Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patient... | NCT02552121 | Trialant
NCT02552121
Sponsor
Seagen Inc.
Status
Completed
Last Update Posted
Apr 8, 2021Actual
Enrollment
33Actual
Phase
Phase 1Phase 2
Conditions
Ovary Cancer
Cervix Cancer
Endometrium Cancer
Bladder Cancer
Prostate Cancer (CRPC)
Esophagus Cancer
Lung Cancer (NSCLC)
Interventions
Tisotumab vedotin (HuMax-TF-ADC)
Countries
United States
Belgium
Denmark
Hungary
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02552121
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GEN702
Secondary IDs
ID
Type
Description
Link
innovaTV 202
Other Identifier
Genmab
Brief Title
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
Official Title
Dose-escalating and Cohort Expansion Safety Trial of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax®-TF-ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor
Acronym
Not provided
Organization
Seagen Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 30, 2015Actual
Primary Completion Date
Dec 13, 2017Actual
Completion Date
Dec 13, 2017Actual
First Submitted Date
Sep 14, 2015
First Submission Date that Met QC Criteria
Sep 15, 2015
First Posted Date
Sep 16, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2018
Results First Submitted that Met QC Criteria
Feb 19, 2019
Results First Posted Date
Mar 12, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 15, 2021
Last Update Posted Date
Apr 8, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Seagen Inc.INDUSTRY
Collaborators
Name
Class
Genmab
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors.
Detailed Description
The study is conducted in two parts. In the Dose Escalation portion of the trial, subjects are enrolled into cohorts at increasing dose levels of tisotumab vedotin (HuMax-TF-ADC) in 28 day treatment cycles.
The Cohort Expansion portion of the trial will further explore the recommended phase 2 dose of tisotumab vedotin (HuMax-TF-ADC) as determined in Part 1.
Conditions Module
Conditions
Ovary Cancer
Cervix Cancer
Endometrium Cancer
Bladder Cancer
Prostate Cancer (CRPC)
Esophagus Cancer
Lung Cancer (NSCLC)
Keywords
ovary cancer
cervix cancer
endometrium cancer
bladder cancer
prostate cancer (CRPC)
esophagus cancer
lung cancer (NSCLC)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
33Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tisotumab vedotin (HuMax-TF-ADC)
Experimental
Drug: Tisotumab vedotin (HuMax-TF-ADC)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tisotumab vedotin (HuMax-TF-ADC)
Drug
Tisotumab vedotin (HuMax-TF-ADC)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Who Experienced at Least One or More Serious Adverse Event (SAE)
A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:
Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Number of Participants Reporting One or More Serious Adverse Events (SAE)
A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:
Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
- Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy.
Patients must have measurable disease according to RECIST v1.1
Age ≥ 18 years.
Acceptable renal function.
Acceptable liver function.
Acceptable hematological status (hematologic support allowed under certain circumstances).
Acceptable coagulation status.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least three months.
A negative serum pregnancy test (if female and aged between 18-55 years old).
Women who are pregnant or breast feeding are not to be included.
Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of HuMax-TF-ADC.
Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.
Exclusion Criteria:
Known past or current coagulation defects.
Diffuse alveolar hemorrhage from vasculitis.
Known bleeding diathesis.
Ongoing major bleeding.
Trauma with increased risk of life-threatening bleeding.
Have clinically significant cardiac disease.
A baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block.
Therapeutic anti-coagulative or long term anti-platelet treatment except use of low dose acetylsalicylic acid (ASA) up to 81 mg/day and non-ASA nonsteroidal anti-inflammatory drugs (NSAIDs).
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.
Have received a cumulative dose of corticosteroid ≥ 150 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.
No dietary supplements allowed during the study period, except multivitamins, vitamin D and calcium.
Major surgery within six weeks or open biopsy within 14 days before drug infusion.
Plan for any major surgery during treatment period.
Patients not willing or able to have a pre-trial tumor biopsy taken (the screening biopsy can be omitted if archived material is available).
Presence or anticipated requirement of epidural catheter in relation to infusions (within 48 hours before and after dose of trial drug).
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within four weeks or five half lives, whichever is longest, before first infusion.
Prior treatment with bevacizumab within twelve weeks before the first infusion.
Prior therapy with a conjugated or unconjugated auristatin derivative.
Radiotherapy within 28 days prior to first dose.
Patients who have not recovered from symptomatic side effects of radiotherapy at the time of initiation of screening procedure.
Known past or current malignancy other than inclusion diagnosis, except for:
Cervical carcinoma of Stage 1B or less.
Non-invasive basal cell or squamous cell skin carcinoma.
Non-invasive, superficial bladder cancer.
Prostate cancer with a current PSA level < 0.1 ng/mL.
Breast cancer in BRCA1 or BRACA2 positive ovarian cancer patients.
Any curable cancer with a complete response (CR) of > 5 years duration.
Radiographic evidence of cavitating pulmonary lesions and tumor adjacent to or invading any large blood vessel unless approved by sponsor.
Ongoing, significant , uncontrolled medical condition.
Presence of peripheral neuropathy.
Active viral, bacterial or fungal infection requiring intravenous treatment with antimicrobial therapy starting less than four weeks prior to first dose.
Oral treatment with antimicrobial therapy starting less than two weeks prior to first dose.
Known human immunodeficiency virus seropositivity.
Positive serology (unless due to vaccination or passive immunization due to Ig therapy) for hepatitis B.
Positive serology for hepatitis C based on test at screening.
Inflammatory bowel disease including Crohn's disease and colitis ulcerosa.
Inflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.
Ongoing acute or chronic inflammatory skin disease.
Active ocular surface disease at baseline (based on ophthalmological evaluation).
History of cicatricial conjunctivitis (as evaluated by an ophthalmologist).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Johann de Bono, Professor
The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
For the Dose Escalation, participants took part in the trial at 3 sites located in Denmark, the United Kingdom (UK), and the United States (USA) from 30 Nov 2015 until 10 Feb 2017. Cohort Expansion trial was performed at 10 sites located in Belgium, UK, Denmark, and the USA from 16 Feb 2016 until the last participant visit on 13 Dec 2017.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
FG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Part 1: Dose Level 1 (Weeks 1-16)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 6, 2017
Dec 10, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Reporting One or More Infusion-related Adverse Events
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
Day 1, Day 8 & Day 15 (+1 day) until end of treatment (Part 1), approximately 48 weeks
Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events
A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events
A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Reporting One or More Treatment-related Adverse Events
A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Number of Participants Reporting One or More Treatment-related Adverse Events
A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.
Baseline to end of trial (Part 2), up to 36 weeks
Part 2: Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Who Experienced a Skin Rash
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Number of Participants Who Experienced a Skin Rash
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Who Experienced a Bleeding Event
Baseline to end of trial (Part 1), up to 72 weeks
Part 2: Number of Participants Who Experienced a Bleeding Event
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Who Experienced a Neuropathy Event
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Number of Participants Who Experienced a Neuropathy Event
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), + 24 hours 3rd infusion (Day 16), + 72 hours 3rd infusion (Day 18), + 168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), +168 hours 3rd infusion (Day 22) of Cycle 1
Part 1: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
Before infusion of Day 1, 8 and 15 of Cycle 1
Part 1: Terminal Phase Elimination Half-life (T1/2) for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 1: Total Clearance (CL) of Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate pharmacokinetic samples were collected after the third dose to define a terminal phase, and therefore CL could not be determined.
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 1: Apparent Volume of Distribution (Vz) for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore Vz could not be determined.
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Total HuMax-TF (Conjugated and Non-conjugated)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 1: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Terminal Phase Elimination Half-life (T1/2) for Total HuMax-TF (Conjugated and Non-conjugated)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)
CL could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.
0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1
Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Conjugated and Non-conjugated)
Vz could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.
0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)
Data is only available for Part 1, for Part 2, inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
Before infusion on Day 1, 8 and 15 of Cycle 1
Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Free Toxin (MMAE)
Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
Before infusion on Day 1, 8 and 15 of Cycle 1
Part 1: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result
Baseline to end of follow-up; maximum follow-up was 24 weeks
Part 2: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Patients Who Experienced Anti-tumor Activity Measured by Tumor Shrinkage
Baseline to end of trial (Part 1), up to 72 weeks
Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen [Prostate Cancer]): Percentage Change From Baseline to End of Study
Baseline to end of follow-up; maximum follow-up was 24 weeks
Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study
Baseline to end of follow-up; maximum follow-up was 24 weeks
Part 2: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study
Baseline to end of trial (Part 2), up to 36 week
Part 1: Best Overall Response (OR)
Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.
Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Baseline to end of trial (Part 1), up to 72 weeks
Part 2: Best Overall Response (OR)
Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.
Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Number of Participants Who Experienced Disease Control
Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.
6, 12, 24 and 36 weeks post first infusion (Part 1)
Part 2: Number of Participants Who Experienced Disease Control
Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.
6, 12, 24 and 36 weeks post first infusion (Part 2)
Part 1: Progression Free Survival (PFS)
Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
Part 2: Progression Free Survival (PFS)
Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.
Baseline to end of trial (Part 2), up to 36 weeks
Part 1: Duration of Response
Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.
Baseline to end of trial (Part 1), up to 72 weeks
Part 2: Duration of Response
Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.
Baseline to end of trial (Part 2), up to 36 weeks
Brussels
Brussels Capital
1000
Belgium
Universitaire Ziekenhuizen Leuven
Leuven
Flemish Brabant
3000
Belgium
Grand Hôpital de Charleroi
Charleroi
Hainaut
6000
Belgium
CHU de Liège
Liège
Liège
4000
Belgium
CHU UCL Namur - site Godinne
Yvoir
Namur
5530
Belgium
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
CHU UCL Namur - Sainte Elisabeth
Namur
5000
Belgium
Rigshospitalet, Copenhagen University Hospital
Copenhagen
DK-2100
Denmark
Petz Aladár Megyei Oktató Kórház
Győr
Győr-Moson-Sopron
9023
Hungary
Debreceni Egyetem Klinikai Központ
Debrecen
Hajdú-Bihar
4032
Hungary
Semmelweis Egyetem Onkológiai Központ
Budapest
1083
Hungary
University College London Hospitals NHS Foundation Trust
London
England
NW1 2PG
United Kingdom
Sarah Cannon Cancer Center
London
England
W1G 6AD
United Kingdom
The Christie NHS Foundation Trust
Manchester
England
M20 4BX
United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton
SM2 5PT
United Kingdom
Passey C, Voellinger J, Gibiansky L, Gunawan R, Nicacio L, Soumaoro I, Hanley WD, Winter H, Gupta M. Exposure-safety and exposure-efficacy analyses for tisotumab vedotin for patients with locally advanced or metastatic solid tumors. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1262-1273. doi: 10.1002/psp4.13007. Epub 2023 Jul 26.
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
FG002
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
FG003
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
FG004
Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
FG005
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
FG006
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
FG007
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Disease Progression
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1: Dose Level 2 (Week 17-48)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Patient Choice
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Part 2: Cohort Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00211 subjects
FG0033 subjects
FG0041 subjects
FG0055 subjects
FG0061 subjects
FG0073 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00211 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Patient Choice
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
BG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
BG002
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
BG003
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
BG004
Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
BG005
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
BG006
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
BG007
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG00211
BG0033
BG0041
BG0055
BG0061
BG0073
BG00833
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG00211
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Belgium
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Weight
The study was conducted in two parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Each part was analyzed separately.
Median
Full Range
kg
Title
Denominators
Categories
Part 1: Dose Escalation
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Height
The study was conducted in two parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Each part was analyzed separately.
Median
Full Range
cm
Title
Denominators
Categories
Part 1: Dose Escalation
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Body Mass Index (BMI)
The study was conducted in two parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Each part was analyzed separately.
Median
Full Range
kg/m^2
Title
Denominators
Categories
Part 1: Dose Escalation
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG0003
OG0016
Primary
Part 2: Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Primary
Part 1: Number of Participants Who Experienced at Least One or More Serious Adverse Event (SAE)
A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:
Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Primary
Part 2: Number of Participants Reporting One or More Serious Adverse Events (SAE)
A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:
Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Primary
Part 1: Number of Participants Reporting One or More Infusion-related Adverse Events
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
Posted
Count of Participants
Participants
Day 1, Day 8 & Day 15 (+1 day) until end of treatment (Part 1), approximately 48 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Primary
Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
Posted
Count of Participants
Participants
Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Primary
Part 1: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events
A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Primary
Part 2: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events
A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Primary
Part 1: Number of Participants Reporting One or More Treatment-related Adverse Events
A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Primary
Part 2: Number of Participants Reporting One or More Treatment-related Adverse Events
A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Number of Participants Who Experienced a Skin Rash
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants Who Experienced a Skin Rash
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Number of Participants Who Experienced a Bleeding Event
Posted
Count of Participants
Participants
Baseline to end of trial (Part 1), up to 72 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants Who Experienced a Bleeding Event
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Number of Participants Who Experienced a Neuropathy Event
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants Who Experienced a Neuropathy Event
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), + 24 hours 3rd infusion (Day 16), + 72 hours 3rd infusion (Day 18), + 168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Secondary
Part 1: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Before infusion of Day 1, 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 1: Terminal Phase Elimination Half-life (T1/2) for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Secondary
Part 1: Total Clearance (CL) of Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate pharmacokinetic samples were collected after the third dose to define a terminal phase, and therefore CL could not be determined.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h/kg
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Secondary
Part 1: Apparent Volume of Distribution (Vz) for Tisotumab Vedotin (HuMax-TF-ADC)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore Vz could not be determined.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/kg
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Secondary
Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Total HuMax-TF (Conjugated and Non-conjugated)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Secondary
Part 1: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Terminal Phase Elimination Half-life (T1/2) for Total HuMax-TF (Conjugated and Non-conjugated)
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Secondary
Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)
CL could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.
CL could not be estimated for Part 1 or Part 2 participants.
Posted
0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Conjugated and Non-conjugated)
Vz could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.
Vz could not be estimated for Part 1 or Part 2 participants.
Posted
0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)
Data is only available for Part 1, for Part 2, inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Data includes all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Before infusion on Day 1, 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)
Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).
Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Secondary
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Free Toxin (MMAE)
Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
Before infusion on Day 1, 8 and 15 of Cycle 1
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 1: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result
Posted
Count of Participants
Participants
Baseline to end of follow-up; maximum follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result
Posted
Count of Participants
Participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Number of Patients Who Experienced Anti-tumor Activity Measured by Tumor Shrinkage
Posted
Count of Participants
Participants
Baseline to end of trial (Part 1), up to 72 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements
Posted
Mean
Standard Deviation
percentage of change
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen [Prostate Cancer]): Percentage Change From Baseline to End of Study
PSA is only assessed for participants with prostate cancer. 2 participants in Part 1 Cohort 1 and 1 participant in Part 1 Cohort 2 had the indication of prostate cancer.
Posted
Mean
Standard Deviation
percentage of change
Baseline to end of follow-up; maximum follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study
CA 125 is only assessed for participants with ovarian and endometrial cancer, 1 participant in Cohort 1 and 1 participant in Cohort 2 had the indication of ovarian or endometrial cancer. No participants from Cohort 1 with the indication of ovarian and endometrial Cancer had results at the End of Study visit.
Posted
Mean
Standard Deviation
percentage of change
Baseline to end of follow-up; maximum follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study
CA 125 was only assessed for participants with Ovarian cancer. No participants from Cohort 5 participated in the End of Trial visit.
Posted
Mean
Standard Deviation
percentage of change
Baseline to end of trial (Part 2), up to 36 week
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG002
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
Secondary
Part 1: Best Overall Response (OR)
Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.
Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Posted
Number
participants
Baseline to end of trial (Part 1), up to 72 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Secondary
Part 2: Best Overall Response (OR)
Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.
Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Posted
Number
participants
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Secondary
Part 1: Number of Participants Who Experienced Disease Control
Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.
Posted
Count of Participants
Participants
6, 12, 24 and 36 weeks post first infusion (Part 1)
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants Who Experienced Disease Control
Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.
Posted
Count of Participants
Participants
6, 12, 24 and 36 weeks post first infusion (Part 2)
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Progression Free Survival (PFS)
Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.
Posted
Median
95% Confidence Interval
weeks
Baseline to end of follow-up; maximum time of follow-up was 24 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
OG000
Secondary
Part 2: Progression Free Survival (PFS)
Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.
Posted
Median
95% Confidence Interval
weeks
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Secondary
Part 1: Duration of Response
Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.
Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.
Posted
Baseline to end of trial (Part 1), up to 72 weeks
ID
Title
Description
OG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
OG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Units
Counts
Participants
Secondary
Part 2: Duration of Response
Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.
Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.
Posted
Baseline to end of trial (Part 2), up to 36 weeks
ID
Title
Description
OG000
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG001
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Time Frame
Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
0
3
1
3
3
3
EG001
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
0
6
2
6
6
6
EG002
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
1
11
9
11
10
11
EG003
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
0
3
2
3
3
3
EG004
Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).
0
1
0
1
1
1
EG005
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, once every 3 weeks (1q3w).
0
5
2
5
5
5
EG006
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
0
1
0
1
0
1
EG007
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
0
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial flutter
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected3 at risk
Symblepharon
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0024 events4 affected11 at risk
EG003
Colonic pseudo-obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
General physical health deterioration
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Disease progression
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events4 affected6 at risk
EG0025 events5 affected11 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected5 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected3 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected6 at risk
EG0026 events5 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected6 at risk
EG0024 events4 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0024 events3 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Tongue blistering
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0026 events4 affected11 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0017 events6 affected6 at risk
EG0026 events5 affected11 at risk
EG003
Escherichia vaginitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Malaise
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0004 events3 affected3 at risk
EG0015 events5 affected6 at risk
EG0028 events7 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected11 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0019 events5 affected6 at risk
EG0023 events3 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0023 events2 affected11 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events4 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected6 at risk
EG0028 events6 affected11 at risk
EG003
Pain
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Oedema
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0014 events3 affected6 at risk
EG0025 events5 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Cell death
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0025 events5 affected11 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Keratitis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Symblepharon
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Blepharitis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Eye pain
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Meibomianitis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected11 at risk
EG003
Episcleritis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Keratopathy
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0023 events2 affected11 at risk
EG003
Vital dye staining cornea present
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Urine output increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0024 events2 affected11 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Radiation proctitis
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D014594
Uterine Neoplasms
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D014571
Urologic Neoplasms
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D005834
Genital Neoplasms, Male
D005832
Genital Diseases, Male
D011469
Prostatic Diseases
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D006258
Head and Neck Neoplasms
D004066
Digestive System Diseases
D004935
Esophageal Diseases
D005767
Gastrointestinal Diseases
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000707142
tisotumab vedotin
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Investigator Judgment
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Disease Progression
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Miscellaneous
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0054 subjects
FG0061 subjects
FG0073 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Disease Progression
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG0041 subjects
FG0054 subjects
FG0060 subjects
FG0073 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
3
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
Adults (18-64 years)
BG0000
BG0013
BG00210
BG0033
BG0041
BG0054
BG0061
BG0073
BG00825
From 65 to 84 years
BG0003
BG0013
BG0021
BG0030
BG004
11
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
Female
BG0001
BG0014
BG00211
BG0033
BG0041
BG0055
BG0061
BG0073
BG00829
Male
BG0002
BG0012
BG0020
BG0030
BG004
11
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
Not Hispanic or Latino
BG0003
BG0016
BG00210
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
11
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0000
BG0011
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0003
BG0015
BG00210
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
11
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
BG0000
BG0010
BG0026
BG0033
BG0040
BG0052
BG0060
BG0072
BG00813
United States
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG00211
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
BG0000
BG0013
BG0021
BG003
Denmark
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG00211
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
BG0002
BG0012
BG0020
BG003
United Kingdom
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG00211
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00833
Title
Measurements
BG0001
BG0011
BG0024
BG003
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0089
Title
Measurements
BG00080.0(76.3 to 80.0)
BG00167.5(48.1 to 85.0)
BG00874.7(48.1 to 85.0)
Part 2: Cohort Expansion
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00211
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00824
Title
Measurements
BG00266.8(40.0 to 89.6)
BG00355.2(41.7 to 63.5)
BG00457.8(57.8 to 57.8)
BG005
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0089
Title
Measurements
BG000171.0(168.0 to 171.4)
BG001162.0(156.0 to 175.0)
BG008168.0(156.0 to 175.0)
Part 2: Cohort Expansion
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00211
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00824
Title
Measurements
BG002159.0(154.0 to 174.0)
BG003157.0(148.0 to 161.0)
BG004160.6(160.6 to 160.6)
BG005
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0089
Title
Measurements
BG00027.4(26.0 to 28.3)
BG00125.5(19.8 to 27.8)
BG00825.7(19.8 to 28.3)
Part 2: Cohort Expansion
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00211
ParticipantsBG0033
ParticipantsBG0041
ParticipantsBG0055
ParticipantsBG0061
ParticipantsBG0073
ParticipantsBG00824
Title
Measurements
BG00226.4(16.9 to 32.5)
BG00322.4(16.1 to 29.0)
BG00422.4(22.4 to 22.4)
BG005
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG00011
OG0013
OG0021
OG0035
OG0040
OG0053
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0009
OG0012
OG0020
OG0032
OG0040
OG0051
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0004
OG0012
OG0021
OG0031
OG0040
OG0051
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG00010
OG0012
OG0020
OG0033
OG0040
OG0051
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0003
OG0016
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0009
OG0013
OG0021
OG0035
OG0040
OG0053
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0016
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
OG0020
OG0033
OG0041
OG0053
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0014
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0021
OG0031
OG0040
OG0051
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0003
OG0015
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0007
OG0013
OG0021
OG0035
OG0040
OG0052
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0003
OG0011
OG0020
OG0032
OG0040
OG0051
OG0003
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG0003336± 7.3
OG0015317± 34.6
Cycle 1 Day 1
Title
Measurements
OG000867± 17.6
OG0011328± 48.0
Cycle 1 Day 8
Title
Measurements
OG0001603± 16.2
OG0012216± 11.7
Cycle 1 Day 15
Title
Measurements
OG000789± 15.6
OG0011411± 94.2
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0002267± 24.8
OG0011755± 19.1
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Participants
OG0002
OG0014
Title
Denominators
Categories
Title
Measurements
OG000920± 3.6
OG0011106± 21.3
OG000
3
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG00021.2± 14.5
OG00130.7± 10.1
Cycle 1 Day 1
Title
Measurements
OG00020.2± 17.9
OG00128.7± 12.1
Cycle 1 Day 8
Title
Measurements
OG00020.9± 14.1
OG00128.0± 8.9
Cycle 1 Day 15
Title
Measurements
OG00019.9± 11.8
OG00126.8± 21.6
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00028.2± 34.5
OG00119.5± 17.6
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
OG0003
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG0005.864± 172.022
OG0015.061± 166.177
Cycle 1 Day 1
Title
Measurements
OG0000.747± 11.547
OG0010.873± 79.228
Cycle 1 Day 8
Title
Measurements
OG0000.717± 0.000
OG0010.846± 86.481
Cycle 1 Day 15
Title
Measurements
OG0001.141± 81.075
OG0011.084± 73.110
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.75± 68.49
OG0010.58± 22.85
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
OG000
3
OG0016
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00030.0± 0
OG00130.0± 0
Cycle 1 Day 8
Title
Measurements
OG000797.3± 22.1
OG0011328.5± 191.8
Cycle 1 Day 15
Title
Measurements
OG000912.1± 23.7
OG001989.0± 44.3
Participants
OG0003
OG0014
Title
Denominators
Categories
Title
Measurements
OG00040.45± 24.78
OG00148.15± 16.47
Participants
OG0002
OG0014
Title
Denominators
Categories
Title
Measurements
OG0000.979± 3.561
OG0011.085± 21.476
Participants
OG0002
OG0014
Title
Denominators
Categories
Title
Measurements
OG00066.75± 6.67
OG00175.37± 14.89
OG0003
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG0003916± 7.3
OG0015573± 15.0
Cycle 1 Day 1
Title
Measurements
OG0001058± 15.0
OG0011530± 34.7
Cycle 1 Day 8
Title
Measurements
OG0001750± 16.2
OG0012460± 8.5
Cycle 1 Day 15
Title
Measurements
OG0001012± 25.7
OG0011426± 28.6
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0002660± 20.0
OG0011948± 35.2
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Counts
Participants
OG0002
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001268± 14.4
OG0011594± 24.6
OG0003
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG00022.1± 9.1
OG00131.7± 11.9
Cycle 1 Day 1
Title
Measurements
OG00020.3± 14.3
OG00130.2± 34.7
Cycle 1 Day 8
Title
Measurements
OG00021.0± 6.3
OG00129.2± 6.6
Cycle 1 Day 15
Title
Measurements
OG00020.9± 12.0
OG00129.2± 16.2
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00027.5± 36.4
OG00120.6± 18.6
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
OG0003
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG00036.445± 99.474
OG00114.003± 117.534
Cycle 1 Day 1
Title
Measurements
OG0000.747± 11.547
OG0010.893± 66.752
Cycle 1 Day 8
Title
Measurements
OG0000.717± 0
OG0010.869± 78.568
Cycle 1 Day 15
Title
Measurements
OG0000.727± 4.784
OG0010.896± 78.665
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.86± 73.61
OG0010.58± 22.85
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Participants
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG00049.56± 17.35
OG00149.34± 19.18
OG003
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG004
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG005
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG006
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG007
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG004
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG005
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG006
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG007
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0003
OG0016
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0016
Title
Measurements
OG000150.0± 0.0
OG001150.0± 0.0
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0016
Title
Measurements
OG0001273.1± 23.4
OG001
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0016
Title
Measurements
OG0001625.1± 24.4
OG001
OG0003
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG000885± 27.1
OG001968± 59.7
Cycle 1 Day 1
Title
Measurements
OG000185± 48.1
OG001185± 75.3
Cycle 1 Day 8
Title
Measurements
OG000180± 14.1
OG001236± 75.5
Cycle 1 Day 15
Title
Measurements
OG000506± 25.3
OG001520± 51.3
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000920± 74.5
OG0011049± 89.4
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
OG000
3
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG0002.76± 23.7
OG0012.88± 52.4
Cycle 1 Day 1
Title
Measurements
OG0001.46± 54.7
OG0011.38± 78.4
Cycle 1 Day 8
Title
Measurements
OG0001.18± 19.8
OG0011.54± 75.4
Cycle 1 Day 15
Title
Measurements
OG0002.76± 23.7
OG0012.88± 52.4
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0003.9± 97.0
OG0013.6± 101.4
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
OG000
3
OG0016
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG000392.024± 3.256
OG001373.366± 6.290
Cycle 1 Day 1
Title
Measurements
OG00044.568± 114.567
OG00132.001± 125.788
Cycle 1 Day 8
Title
Measurements
OG00010.354± 165.509
OG00120.837± 106.094
Cycle 1 Day 15
Title
Measurements
OG00054.511± 20.424
OG00132.537± 63.879
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Cycle 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000307.05± 36.52
OG001410.61± 3.82
Cycle 1 Dose 1
ParticipantsOG00011
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 2
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Dose 3
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
3
OG0016
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00012.50± 0
OG00112.50± 0
Cycle 1 Day 8
Title
Measurements
OG000853.42± 22.93
OG0011061.28± 87.81
Cycle 1 Day 15
Title
Measurements
OG0001013.22± 14.47
OG0011384.29± 83.43
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
3
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG000-17.34± 43.388
OG00132.78± 83.933
OG002-63.27± NAOnly 1 participant is included in this arm, therefore Standard deviation cannot be calculated.
OG0030.74± 21.877
OG0040± NAOnly 1 participant is included in this arm, therefore Standard deviation cannot be calculated.
OG00511.76± 27.658
2
OG0011
Title
Denominators
Categories
Title
Measurements
OG00023.42± 61.686
OG00112.97± NAOnly 1 participant is included in the analysis, therefore Standard deviation cannot be calculated.
OG000
0
OG0011
Title
Denominators
Categories
Title
Measurements
OG001186.21± NAOnly 1 participant was included in the analysis, therefore Standard deviation could not calculated.
Units
Counts
Participants
OG0008
OG0011
OG0020
Title
Denominators
Categories
Title
Measurements
OG000-31.75± 36.235
OG001-32.50± NAOnly 1 participant was included in the analysis, therefore Standard deviation could not be calculated.
Units
Counts
Participants
OG0003
OG0016
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
Partial Response
Title
Measurements
OG0000
OG0011
Stable Disease
Title
Measurements
OG0002
OG0013
Progressive Disease
Title
Measurements
OG0001
OG0011
Not Evaluable
Title
Measurements
OG0000
OG0011
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
OG002
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Partial Response
Title
Measurements
OG0003
OG0011
OG0021
OG003
Stable Disease
Title
Measurements
OG0003
OG0010
OG0020
OG003
Progressive Disease
Title
Measurements
OG0002
OG0012
OG0020
OG003
Not Evaluable
Title
Measurements
OG0003
OG0010
OG0020
OG003
3
OG0016
Title
Denominators
Categories
6 Weeks
Title
Measurements
Disease Control - Yes
OG0002
OG0013
Disease Control - No
OG0001
OG0013
12 Weeks
Title
Measurements
Disease Control - Yes
OG0000
OG0010
Disease Control - No
OG0003
OG001
24 Weeks
Title
Measurements
Disease Control - Yes
OG0000
OG0010
Disease Control - No
OG0003
OG001
36 Weeks
Title
Measurements
Disease Control - Yes
OG0000
OG0010
Disease Control - No
OG0003
OG001
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Units
Counts
Participants
OG00011
OG0013
OG0021
OG0035
OG0041
OG0053
Title
Denominators
Categories
6 Weeks
Title
Measurements
Disease Control - Yes
OG0006
OG0011
OG0021
OG0034
OG0040
OG0052
Disease Control - No
OG0005
OG0012
OG0020
OG0031
OG004
12 Weeks
Title
Measurements
Disease Control - Yes
OG0002
OG0011
OG0021
OG003
24 Weeks
Title
Measurements
Disease Control - Yes
OG0000
OG0010
OG0020
OG003
36 Weeks
Title
Measurements
Disease Control - Yes
OG0000
OG0010
OG0020
OG003
2
OG0011
Title
Denominators
Categories
Title
Measurements
OG00011.3(7.3 to 15.3)
OG001NA(7.1 to NA)Could not be estimated due to the low number of events disease progression or death.
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity.
Units
Counts
Participants
OG0004
OG0012
OG0021
OG0034
OG0041
OG0053
Title
Denominators
Categories
Title
Measurements
OG00010.7(2.0 to NA)Could not be estimated due to the low number of events disease progression or death.
OG0018.0(4.3 to NA)Could not be estimated due to the low number of events disease progression or death.
OG00222.0(NA to NA)Could not be estimated due to the low number of events disease progression or death.
OG00314.0(9.1 to NA)Could not be estimated due to the low number of events disease progression or death.
OG0045.0(NA to NA)Could not be estimated due to the low number of events disease progression or death.
OG00511.9(11.0 to 17.1)
OG0000
OG0010
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG003
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
OG004
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
OG005
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.