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| Name | Class |
|---|---|
| Genmab | INDUSTRY |
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This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).
The study objectives are to evaluate the safety, antitumor activity, and pharmacokinetics of tisotumab vedotin (TV) administered every 3 weeks or on Days 1, 8, and 15 of every 4-week cycle (3Q4W) for patients with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has relapsed within 6 months of the completion of platinum-based treatment and determined to be platinum resistant. All patients must have PROC and be eligible for single agent chemotherapy.
The safety run-in period will evaluate the safety of a weekly schedule. The highest dose level that is considered safe will be the recommended phase 2 dose (RP2D) and will be used in Part A. In Part A, participants will be randomized in a 1:1 ratio to receive tisotumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisotumab vedotin on Days 1, 8, and 15 of every 4-week cycle (weekly regimen) at a pre-specified dose level, if the dose level is considered safe and tolerable in the safety run-in period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Run-In (3Q4W Schedule) | Experimental | 28-day, 3 dose cycle |
|
| Part A: Tisotumab Vedotin | Experimental | 21-day, single dose cycle |
|
| Part A: Tisotumab Vedotin (3Q4W Schedule) | Experimental | 28-day, 3 dose cycle |
|
| Part B: Tisotumab Vedotin (3Q4W Schedule) | Experimental | 28-day, 3 dose cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tisotumab vedotin | Drug | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) (Safety Run-In Only) | Incidence of dose-limiting toxicity (DLT) was evaluated in participants enrolled in the Safety Run-In, who were followed for protocol-defined DLT events up to 28 days after the first dose of tisotumab vedotin. | Up to 28 days |
| Confirmed Objective Response Rate (ORR) (Part B) | Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator | Up to 9.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) (Part B) | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. |
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Inclusion Criteria:
Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Safety run-in only: PROC. Patients may have received more than 1 prior systemic treatment regimen in the PROC setting.
Part A and Part B only: Patients with PROC who have received 1 to 3 anticancer lines of therapy overall, including at least 1 line of therapy containing bevacizumab or biosimilar.
Measurable disease according to RECIST v1.1 as assessed by the investigator
An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Life expectancy of at least 3 months
Able to provide fresh or archival tissue for biomarker analysis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristi Schmidt, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center South Bay | San Jose | California | 95124 | United States | ||
| Poudre Valley Health System (PVHS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41044356 | Derived | Feng S, Gunawan R, Passey C, Voellinger J, Polhamus D, Gerritsen A, O'Day C, Carret AS, Soumaoro I, Gupta M, Hanley WD. Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. J Pharmacokinet Pharmacodyn. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w. |
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A total of 98 participants were enrolled into the Safety Run-In and Part B Expansion cohorts, of which 94 received study drug. No participants were enrolled into Part A.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Run-In 0.9 mg/kg 3Q4W | Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| FG001 | Safety Run-In 1.2 mg/kg 3Q4W | Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2020 | Jan 27, 2023 |
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|
| Up to 23.0 months |
| Confirmed and Unconfirmed ORR (Part B) | Proportion of participants who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator | Up to 9.7 months |
| Cancer Antigen 125 (CA-125) Response Rate According to Gynecologic Cancer Intergroup (GCIG) Criteria (Part B) | Percentage of participants who have at least a 50% reduction in CA-125 value from baseline | Up to 10.1 months |
| Overall Response According to the Gynecological Cancer Intergroup (GCIG) Combined RECIST and CA-125 Criteria (Part B) | Percentage of participants whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria | Up to 10.1 months |
| Duration of Response (DOR) (Part B) | Time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or death due to any cause, whichever comes first | Up to 8.3 months |
| Disease Control Rate (DCR) (Part B) | Percentage of participants who achieved a confirmed Complete Response(CR) or Partial Response (PR) per RECIST v1.1 as assessed by the investigator, or meet the Stable Disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks. | Up to 3.0 months |
| Time to Response (TTR) (Part B) | Time from the start of study treatment to the first documentation of objective response (CR or PR that is subsequently confirmed) | Up to 23.0 months |
| Progression-free Survival (PFS) (Part B) | Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first | Up to 9.7 months |
| Overall Survival (OS) (Part B) | Time from the start of study treatment to date of death due to any cause | Up to 23.0 months |
| Incidence of Antitherapeutic Antibodies (ATA) (Part B) | The proportion of participants who develop ATA at any time during the study. A positive baseline ATA result is considered positive post-baseline if the post-baseline ATA titer result is at least four times higher than the baseline result. | Up to 6.9 months |
| Pharmacokinetic (PK) Parameter: Antibody-Drug Conjugate (ADC) Maximum Concentration (Cmax) (Part B) | ADC Cmax was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: ADC Time of Cmax (Tmax) (Part B) | ADC Tmax was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B) | ADC AUC was derived from the PK blood samples collected. | Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose). |
| PK Parameter: Free Monomethyl Auristatin E (MMAE) Cmax (Part B) | MMAE Cmax was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: MMAE Tmax (Part B) | MMAE Tmax was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: MMAE AUC (Part B) | MMAE AUC was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: MMAE Trough Concentration (Ctrough) (Part B) | MMAE Ctrough was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: Total Antibody (TAb) Cmax (Part B) | TAb Cmax was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: TAb Tmax (Part B) | TAb Tmax was derived from the PK blood samples collected. | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
| PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B) | TAb AUC was derived from the PK blood samples collected. | Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose). |
| Fort Collins |
| Colorado |
| 80524 |
| United States |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Miami Cancer Institute- Plantation (MCIP) | Miami | Florida | 33176 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| University of Missouri Healthcare / Ellis Fischel Cancer Center | Columbia | Missouri | 65212 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai Chelsea | New York | New York | 10011 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | United States |
| Ohio State University Clinical Trials Management Office | Columbus | Ohio | 43210 | United States |
| Cleveland Clinic Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Texas Oncology - Fort Worth | Dallas | Texas | 75246 | United States |
| Renovatio Clinical | The Woodlands | Texas | 77380 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Algemeen Ziekenhuis Maria Middelares | Ghent | Other | 9000 | Belgium |
| Universitair Ziekenhuis Leuven | Lueven | Other | 3000 | Belgium |
| Aalborg Universite Hospital | Aalborg | Other | 9100 | Denmark |
| Mater Private | Dublin | Other | D07 WKW8 | Ireland |
| Cork University Hospital | Wilton | Other | T12 E8YV | Ireland |
| Ospedale Ramazzini di Carpi | Carpi | Other | 41012 | Italy |
| IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l | Meldola | Other | 47014 | Italy |
| Istituto Europeo di Oncologia | Milan | Other | 20141 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Naples | Other | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino | Rome | Other | 00168 | Italy |
| Hospital Universitario Vall d'Hebron | Barcelona | Other | 08035 | Spain |
| L'Institut Catala d'Oncologia | L'Hospitalet de Llobregat | Other | 08907 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | Other | 28034 | Spain |
| HM Centro Integral Oncologico Clara Campal | Madrid | Other | 28050 | Spain |
| Clinica Universidad de Navarra | Pamplona | Other | 31008 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Other | 28223 | Spain |
| FG002 | Part A Q3W | Tisotumab Vedotin 2.0 mg/kg by IV infusion on Day 1 of each 3-week treatment cycle |
| FG003 | Part A 3Q4W | Tisotumab Vedotin by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| FG004 | Part B Expansion | Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set includes all participants who received any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Run-In 0.9 mg/kg 3Q4W | Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| BG001 | Safety Run-In 1.2 mg/kg 3Q4W | Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| BG002 | Part B Expansion | Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Score | Measure Description: 0=Normal activity; 1=Symtoms but ambulatory; 2=In bed <50% of the time; 3= In bed > 50% of the time; 4=100% bedridden; 5=Dead | Count of Participants | Participants |
|
| 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 | Number of Participants With Dose-Limiting Toxicities (DLTs) (Safety Run-In Only) | Incidence of dose-limiting toxicity (DLT) was evaluated in participants enrolled in the Safety Run-In, who were followed for protocol-defined DLT events up to 28 days after the first dose of tisotumab vedotin. | Participants from the Safety Analysis Set that were enrolled in the Safety Run-In. The Safety Analysis Set includes all participants who received any amount of study drug. | Posted | Count of Participants | Participants | Up to 28 days |
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| Primary | Confirmed Objective Response Rate (ORR) (Part B) | Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator | The Full Analysis Set includes all participants who received any amount of study drug. | Posted | Count of Participants | Participants | Up to 9.7 months |
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| Secondary | Number of Participants With Adverse Events (AEs) (Part B) | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. | The Safety Analysis Set includes all participants who received any amount of study drug. | Posted | Count of Participants | Participants | Up to 23.0 months |
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| Secondary | Confirmed and Unconfirmed ORR (Part B) | Proportion of participants who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator | The Full Analysis Set includes all participants who received any amount of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 9.7 months |
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| Secondary | Cancer Antigen 125 (CA-125) Response Rate According to Gynecologic Cancer Intergroup (GCIG) Criteria (Part B) | Percentage of participants who have at least a 50% reduction in CA-125 value from baseline | The CA-125 evaluable analysis set includes participants who have an elevated baseline CA-125 value of ≥2 x ULN (upper limit of normal) within 2 weeks prior to the first dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 10.1 months |
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| Secondary | Overall Response According to the Gynecological Cancer Intergroup (GCIG) Combined RECIST and CA-125 Criteria (Part B) | Percentage of participants whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria | The Full Analysis Set includes all participants who received any amount of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 10.1 months |
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| Secondary | Duration of Response (DOR) (Part B) | Time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or death due to any cause, whichever comes first | Subset of the Full Analysis Set includes all participants who received any amount of study drug and had a confirmed CR or PR. | Posted | Median | 95% Confidence Interval | Months | Up to 8.3 months |
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| Secondary | Disease Control Rate (DCR) (Part B) | Percentage of participants who achieved a confirmed Complete Response(CR) or Partial Response (PR) per RECIST v1.1 as assessed by the investigator, or meet the Stable Disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks. | The Full Analysis Set includes all participants who received any amount of study drug | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 3.0 months |
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| Secondary | Time to Response (TTR) (Part B) | Time from the start of study treatment to the first documentation of objective response (CR or PR that is subsequently confirmed) | Subset of the Full Analysis Set includes all participants who received any amount of study drug and had a confirmed CR or PR. | Posted | Median | Full Range | Months | Up to 23.0 months |
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| Secondary | Progression-free Survival (PFS) (Part B) | Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first | The Full Analysis Set includes all participants who received any amount of study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 9.7 months |
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| Secondary | Overall Survival (OS) (Part B) | Time from the start of study treatment to date of death due to any cause | The Full Analysis Set includes all participants who received any amount of study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 23.0 months |
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| Secondary | Incidence of Antitherapeutic Antibodies (ATA) (Part B) | The proportion of participants who develop ATA at any time during the study. A positive baseline ATA result is considered positive post-baseline if the post-baseline ATA titer result is at least four times higher than the baseline result. | Participants in the Safety Analysis Set with a baseline and at least one post-baseline ATA sample. | Posted | Count of Participants | Participants | Up to 6.9 months |
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| Secondary | Pharmacokinetic (PK) Parameter: Antibody-Drug Conjugate (ADC) Maximum Concentration (Cmax) (Part B) | ADC Cmax was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: ADC Time of Cmax (Tmax) (Part B) | ADC Tmax was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B) | ADC AUC was derived from the PK blood samples collected. | PK Analysis Set includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL*day | Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose). |
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| Secondary | PK Parameter: Free Monomethyl Auristatin E (MMAE) Cmax (Part B) | MMAE Cmax was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: MMAE Tmax (Part B) | MMAE Tmax was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: MMAE AUC (Part B) | MMAE AUC was derived from the PK blood samples collected. | PK Analysis Set includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL*day | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: MMAE Trough Concentration (Ctrough) (Part B) | MMAE Ctrough was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: Total Antibody (TAb) Cmax (Part B) | TAb Cmax was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: TAb Tmax (Part B) | TAb Tmax was derived from the PK blood samples collected. | PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle. |
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| Secondary | PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B) | TAb AUC was derived from the PK blood samples collected. | PK Analysis Set includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL*day | Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose). |
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Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months.
All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Run-In 0.9 mg/kg 3Q4W | Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle | 6 | 8 | 2 | 7 | 7 | 7 |
| EG001 | Safety Run-In 1.2 mg/kg 3Q4W | Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle | 5 | 8 | 4 | 8 | 8 | 8 |
| EG002 | Part B Expansion | Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle | 53 | 82 | 28 | 79 | 77 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Conjunctival ulcer | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Ectropion | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Symblepharon | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA v25.0 | Systematic Assessment |
| |
| Incision site impaired healing | Injury, poisoning and procedural complications | MedDRA v25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seagen Inc. | (855) 473-2436 | medinfo@seagen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2021 | Jan 27, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | 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 |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707142 | tisotumab vedotin |
Not provided
Not provided
Not provided
| Intersex |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not of Hispanic or Latino/a, or of Spanish Origin |
|
| Unknown |
|
| Grade 1 |
|
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