A Study of ADXS11-001 or MEDI4736 Alone or Combination In... | NCT02291055 | Trialant
NCT02291055
Sponsor
Advaxis, Inc.
Status
Terminated
Last Update Posted
Mar 20, 2023Actual
Enrollment
75Actual
Phase
Phase 1Phase 2
Conditions
Cervical Cancer
Cancer
Head and Neck Cancer
Interventions
ADXS11-001
MEDI4736
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02291055
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ADXS001-04
Secondary IDs
Not provided
Brief Title
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
Official Title
Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer
Acronym
Not provided
Organization
Advaxis, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2015Actual
Primary Completion Date
Jul 9, 2019Actual
Completion Date
Nov 20, 2020Actual
First Submitted Date
Nov 6, 2014
First Submission Date that Met QC Criteria
Nov 13, 2014
First Posted Date
Nov 14, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 20, 2023
Results First Submitted that Met QC Criteria
Feb 20, 2023
Results First Posted Date
Mar 20, 2023Actual
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
Feb 20, 2023
Last Update Posted Date
Mar 20, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Advaxis, Inc.INDUSTRY
Collaborators
Name
Class
MedImmune LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
This was a multicenter, open-label, 2-part randomized study of MEDI4736 administered as monotherapy or in combination with ADXS11-001 to participants with recurrent/persistent or metastatic squamous or non-squamous carcinoma of the cervix or metastatic human papillomaviruses (HPV)+ squamous cell carcinoma of the head and neck (SCCHN).
Detailed Description
The study was conducted in 2 parts Part A (dose-escalation and expansion) and Part B (expansion).
Part A:
Part A of the study was a Phase 1 dose escalation evaluation of the combination treatment of ADXS11-001 at a fixed dose of 1×10^9 colony-forming units (CFU) administered intravenously (IV) every 4 weeks (Q4W) and escalating doses of MEDI4736 (3 mg/kg and 10 mg/kg) administered IV every 2 weeks (Q2W) to determine the safety and tolerability of the combination and to identify a recommended Phase 2 dose (RP2D). Part A also included an expansion cohort of participants with metastatic SCCHN only. Once the RP2D was identified, the expansion cohort of Part A of the study were to commence.
Part B:
Part B of the study was a Phase 2 design in which participants who had failed at least 1 prior systemic treatment for their recurrent, persistent or metastatic cervical cancer were enrolled and randomized 1:1 to receive either MEDI4736 10 mg/kg alone or MEDI4736 10 mg/kg in combination with ADXS11-001 1×10^9 CFU.
Conditions Module
Conditions
Cervical Cancer
Cancer
Head and Neck Cancer
Keywords
Not provided
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
75Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Experimental
Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Drug: ADXS11-001
Drug: MEDI4736
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Experimental
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Drug: ADXS11-001
Drug: MEDI4736
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Experimental
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ADXS11-001
Drug
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part A and Part B
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. Any worsening (ie, any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also considered an AE. A serious adverse event (SAE) was any AE that: results in death; life threatening; resulted in or prolonged an existing inpatient hospitalization, persistent or significant disability/incapacity; congenital anomaly; a new cancer; associated with an overdose; another important medical event. Treatment emergent was defined as events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication.
From first dose until 30 days after last dose (maximum duration: 98 weeks)
Progression Free Survival (Part A and Part B): Cervical Cancer Population
Progression-free survival (PFS) was defined as the time from randomization until objective tumor progression based on response evaluation criteria in solid tumors (RECIST) version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Progression Free Survival (Part A): Human Papillomavirus (HPV)+ Head and Neck Cancer Population
PFS was defined as the time from randomization until objective tumor progression based on RECIST version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have histological diagnosis of SCCHN with confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or adenocarcinoma of the cervix which HPV positivity is not required
Have measurable and/or evaluable disease by response evaluation criteria in solid tumors (RECIST) 1.1
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate organ function defined by the protocol.
Exclusion Criteria:
Has any prior Grade ≥3 immune-related adverse event (irAE) while receiving immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE >Grade 1.
Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Day 1 of trial treatment.
Has any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for invasive malignancy within 2 years. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant
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
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Site
Los Angeles
California
United States
Site
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Slomovitz BM, Moore K, Vangala S, Parsi M, Sheerie S, John Heyburn J ,Posner M. Phase II study of durvalumab alone or in combination with ADXS11-001 (AXAL) in recurrent/persistent or metastatic cervical cancer. Annual Meeting on Women's Cancer. March 28-31, 2020. Toronto Canada.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants with a diagnosis of cervical cancer and human papillomavirus (HPV) positive squamous cell carcinoma of head and neck (SCCHN) were enrolled in the study.
Recruitment Details
Participants were enrolled at study centers in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
May 8, 2015
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
Randomized
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
Drug: ADXS11-001
Drug: MEDI4736
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Experimental
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Drug: MEDI4736
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Experimental
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Drug: ADXS11-001
Drug: MEDI4736
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
MEDI4736
Drug
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
The objective response is defined as confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The objective response is defined as confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
The objective response is defined as confirmed CR or confirmed PR based on immune-related RECIST (irRECIST) v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
The DCR is defined percentage of participants with CR, PR, or stable disease (SD) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The DCR is defined percentage of participants with CR, PR, or SD based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
Overall Survival: Cervical Cancer Population
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
From first dose until death (maximum duration: 146 weeks)
Overall Survival: HPV+ Head and Neck Cancer Population
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
From first dose until death (maximum duration: 146 weeks)
New Haven
Connecticut
United States
Site
Jacksonville
Florida
United States
Site
Miami
Florida
United States
Site
Tampa
Florida
United States
Site
Urbana
Illinois
United States
Site
Lexington
Kentucky
United States
Site
Baltimore
Maryland
United States
Site
Detroit
Michigan
United States
Site
Omaha
Nebraska
United States
Site
Brooklyn
New York
United States
Site
New York
New York
United States
Site
Canton
Ohio
United States
Site
Hilliard
Ohio
United States
Site
Oklahoma City
Oklahoma
United States
Site
Chattanooga
Tennessee
United States
Site
Milwaukee
Wisconsin
United States
FG001
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
FG002
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
FG003
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
FG004
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
FG0005 subjects
FG0015 subjects
FG00211 subjects
FG00327 subjects
FG00427 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG0028 subjects
FG00327 subjects
FG00427 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0012 subjects
FG0025 subjects
FG0038 subjects
FG00412 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
Other
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0034 subjects
FG004
All Treated Population included participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
BG001
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
BG002
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
BG003
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
BG004
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0015
BG00211
BG00327
BG00427
BG00575
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
Asian
BG0001
BG0010
BG002
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 Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part A and Part B
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. Any worsening (ie, any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also considered an AE. A serious adverse event (SAE) was any AE that: results in death; life threatening; resulted in or prolonged an existing inpatient hospitalization, persistent or significant disability/incapacity; congenital anomaly; a new cancer; associated with an overdose; another important medical event. Treatment emergent was defined as events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication.
All Treated Population.
Posted
Number
participants
From first dose until 30 days after last dose (maximum duration: 98 weeks)
ID
Title
Description
OG000
Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG001
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG002
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG003
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0005
OG0015
OG00211
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0005
OG0015
OG00211
OG003
Primary
Progression Free Survival (Part A and Part B): Cervical Cancer Population
Progression-free survival (PFS) was defined as the time from randomization until objective tumor progression based on response evaluation criteria in solid tumors (RECIST) version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
The objective response rate (ORR) evaluable with cervical cancer population included all participants in the All Treated Population who had cervical cancer and had at least 1 post-baseline radiologic tumor response assessment (complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]).
Posted
Median
95% Confidence Interval
months
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Progression Free Survival (Part A): Human Papillomavirus (HPV)+ Head and Neck Cancer Population
PFS was defined as the time from randomization until objective tumor progression based on RECIST version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.
The ORR Evaluable with HPV+ head and neck cancer population included all participants in the All Treated Population who had HPV+ head and neck cancer and had at least 1 post-baseline radiologic tumor response assessment (CR, PR, SD, or PD).
Posted
Median
95% Confidence Interval
months
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and expansion cohorts. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
The objective response is defined as confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
ORR Evaluable with Cervical Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG001
Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and Part B expansion cohort. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The objective response is defined as confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
ORR Evaluable with HPV+ Head and Neck Cancer Population
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and expansion cohorts. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Primary
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
The objective response is defined as confirmed CR or confirmed PR based on immune-related RECIST (irRECIST) v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
ORR Evaluable with Cervical Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG001
Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and Part B expansion cohort. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.
ORR Evaluable with HPV+ Head and Neck Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and expansion cohorts. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
Primary
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population
The DCR is defined percentage of participants with CR, PR, or stable disease (SD) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
ORR Evaluable with Cervical Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The DCR is defined percentage of participants with CR, PR, or SD based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
ORR Evaluable with HPV+ Head and Neck Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and expansion cohorts. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
ORR Evaluable with Cervical Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG001
Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and Part B expansion cohort. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population
The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.
ORR Evaluable with HPV+ Head and Neck Cancer Population.
Posted
Number
95% Confidence Interval
percentage of participants
From randomization until objective tumor progression or death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and expansion cohorts. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Primary
Overall Survival: Cervical Cancer Population
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
All Treated Population.
Posted
Median
95% Confidence Interval
months
From first dose until death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG001
Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and Part B expansion cohort. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Primary
Overall Survival: HPV+ Head and Neck Cancer Population
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
All Treated Population.
Posted
Median
95% Confidence Interval
months
From first dose until death (maximum duration: 146 weeks)
ID
Title
Description
OG000
Part A Escalation and Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and expansion cohorts. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG000
Time Frame
All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks)
Description
All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
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 A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
2
5
2
5
5
5
EG001
Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
2
5
3
5
5
5
EG002
Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
7
11
4
11
11
11
EG003
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
8
27
13
27
25
27
EG004
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
12
27
15
27
27
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG0030 affected27 at risk
EG0041 affected27 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Small intestine obstruction
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Asthenia
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Chest pain
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Disease progression
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pain
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Performance status decreased
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Septic shock
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Upper respiratory track infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Urinary tract stoma complication
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Metastasis to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Embolism
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected5 at risk
EG0023 affected11 at risk
EG00310 affected27 at risk
EG0048 affected27 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected5 at risk
EG0023 affected11 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Vision blurred
Eye disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Visual impairment
Eye disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0023 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected5 at risk
EG0022 affected11 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Levator syndrome
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0013 affected5 at risk
EG0023 affected11 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Tongue discomfort
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0023 affected11 at risk
EG003
Asthenia
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Chest discomfort
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Chest pain
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Chills
General disorders
MedDRA v20.1
Systematic Assessment
EG0004 affected5 at risk
EG0015 affected5 at risk
EG0021 affected11 at risk
EG003
Disease progression
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Face oedema
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Fatigue
General disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected5 at risk
EG0025 affected11 at risk
EG003
Influenza like illness
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Malaise
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA v20.1
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Pain
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Performance status decreased
General disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Peripheral swelling
General disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA v20.1
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected5 at risk
EG0023 affected11 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0025 affected11 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Septic shock
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Stoma site candida
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Stoma site inflammation
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Urinary tract stoma complication
Injury, poisoning and procedural complications
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Blood calcium decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Blood creatine increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Blood glucose increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Blood potassium increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Blood urea increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Heart rate increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Platelet count decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Po2 decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Protein total increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Respiratory rate decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Thyroxine increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Tri-iodothyronine decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Weight decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Weight increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0022 affected11 at risk
EG003
White blood cell count increased
Investigations
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected5 at risk
EG0023 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected5 at risk
EG0022 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Amnesia
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Lethargy
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Tremor
Nervous system disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected11 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Vulvovaginal swelling
Reproductive system and breast disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected11 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected11 at risk
EG003
Embolism
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Flushing
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0012 affected5 at risk
EG0025 affected11 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected11 at risk
EG003
Varicose vein
Vascular disorders
MedDRA v20.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected11 at risk
EG003
Based on a discussion with the FDA, a 1-year duration of the Listeria monocytogenes surveillance period was considered sufficient (instead of protocol specified 3-years period) to monitor and characterize any potential risk associated with delayed listeremia, and therefore, the study was terminated early.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Investigator shall seek the Sponsor's written approval for study results publication which shall not be unreasonably withheld. Such publication by Institution and/or Investigator may be no earlier than after a cooperative publication has been published with Sponsor or 1 year from date of completion or termination of the Study & only after review and comment by Sponsor. Institution agrees to provide Sponsor a copy of proposed publication at least 60 days prior to submission to a publisher.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000613593
durvalumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
10 subjects
2 subjects
1 subjects
0 subjects
0
BG0040
BG0050
Between 18 and 65 years
BG0005
BG0014
BG0029
BG00323
BG00427
BG00568
>=65 years
BG0000
BG0011
BG0022
BG0034
BG0040
BG0057
0
BG00327
BG00427
BG00563
Male
BG0000
BG0011
BG00211
BG0030
BG0040
BG00512
2
BG0033
BG0046
BG00512
Not Hispanic or Latino
BG0005
BG0014
BG0029
BG00324
BG00421
BG00563
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0030
BG0041
BG0052
Black or African American
BG0001
BG0010
BG0021
BG0035
BG0043
BG00510
White
BG0003
BG0014
BG00210
BG00319
BG00421
BG00557
Other
BG0000
BG0011
BG0020
BG0033
BG0042
BG0056
OG004
Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
27
OG00427
25
OG00427
TESAEs
Title
Measurements
OG0002
OG0013
OG0024
OG00313
OG00415
OG001
Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and Part B expansion cohort. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG002
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0004
OG00123
OG00220
Title
Denominators
Categories
Title
Measurements
OG0003.7(1.8 to 22.1)
OG0012.1(1.7 to 3.8)
OG0025.0(1.8 to 6.9)
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG0003.5(1.6 to 5.3)
OG002
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0004
OG00123
OG00220
Title
Denominators
Categories
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0018.7(1.1 to 28.0)
OG00210.0(1.2 to 31.7)
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG0000.00(0.0 to 0.0)
OG002
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0004
OG00123
OG00220
Title
Denominators
Categories
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0018.7(1.1 to 28.0)
OG00210.0(1.2 to 31.7)
OG00012
Title
Denominators
Categories
Title
Measurements
OG0000.00(0.0 to 0.0)
OG001
Part A + Part B (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes in Part A escalation and Part B expansion cohort. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
OG002
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0004
OG00123
OG00220
Title
Denominators
Categories
Title
Measurements
OG00050.0(6.8 to 93.2)
OG00147.8(26.8 to 69.4)
OG00265.0(40.8 to 84.6)
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG00058.3(27.7 to 84.8)
OG002
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0004
OG00123
OG00220
Title
Denominators
Categories
Title
Measurements
OG00075.0(19.4 to 99.4)
OG00152.2(30.6 to 73.2)
OG00265.0(40.8 to 84.6)
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG00050.0(21.1 to 78.9)
OG002
Part B Expansion (Cervical): 10 mg/kg MEDI4736
Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Units
Counts
Participants
OG0005
OG00130
OG00227
Title
Denominators
Categories
Title
Measurements
OG000NA(2.8 to NA)Median, and upper limits of 95% CI were not estimable as more than 50% of participants were censored.
OG0019.3(6.0 to NA)Upper limits of 95% CI were not estimable as more than 50% of participants were censored.
OG0029.2(6.9 to NA)Upper limits of 95% CI were not estimable as more than 50% of participants were censored.
13
Title
Denominators
Categories
Title
Measurements
OG0004.8(3.6 to NA)Upper limits of 95% CI were not estimable as more than 50% of participants were censored.