A Study of Cabiralizumab Given With Nivolumab With and Wi... | NCT03336216 | Trialant
NCT03336216
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Jul 23, 2024Actual
Enrollment
205Actual
Phase
Phase 2
Conditions
Advanced Pancreatic Cancer
Interventions
Cabiralizumab
Nab-paclitaxel
Onivyde
Nivolumab
Fluorouracil
Gemcitabine
Oxaliplatin
Leucovorin
Irinotecan Hydrochloride
Countries
United States
Canada
Denmark
Germany
Italy
Japan
South Korea
Spain
Switzerland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03336216
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA025-006
Secondary IDs
Not provided
Brief Title
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Official Title
A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 18, 2017Actual
Primary Completion Date
Jun 1, 2023Actual
Completion Date
Jun 1, 2023Actual
First Submitted Date
Nov 6, 2017
First Submission Date that Met QC Criteria
Nov 6, 2017
First Posted Date
Nov 8, 2017Actual
Results Waived
Not provided
Results First Submitted Date
May 30, 2024
Results First Submitted that Met QC Criteria
Jul 21, 2024
Results First Posted Date
Jul 23, 2024Actual
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
Jul 21, 2024
Last Update Posted Date
Jul 23, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
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
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Pancreatic 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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
205Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A
Active Comparator
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
Drug: Nab-paclitaxel
Drug: Onivyde
Drug: Fluorouracil
Drug: Gemcitabine
Drug: Leucovorin
Drug: Irinotecan Hydrochloride
Arm B
Experimental
Cabiralizumab Q2W + Nivolumab Q4W
Biological: Cabiralizumab
Biological: Nivolumab
Arm C
Experimental
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
Biological: Cabiralizumab
Drug: Nab-paclitaxel
Biological: Nivolumab
Drug: Gemcitabine
Arm D
Experimental
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
Biological: Cabiralizumab
Biological: Nivolumab
Drug: Fluorouracil
Drug: Oxaliplatin
Drug: Leucovorin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cabiralizumab
Biological
specified dose on specified days
Arm B
Arm C
Arm D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) by BICR
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Secondary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) by Investigator
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy
ECOG Performance status 0-1
Adequate organ functions
Measurable disease
Exclusion Criteria:
Suspected or known CNS metastasis
Participants with active, known, or suspected autoimmune disease
Uncontrolled or significant cardiovascular disease
Prior exposure to selected immune cell-modulating antibody regimens
Participants receive Investigator choice of chemotherapy:
gemcitabine + nab-paclitaxel
5-Fluorouracil/Leucovorin/Irinotecan Liposome
FG001
Arm B: Cabiralizumab + Nivolumab
Periods
Title
Milestones
Reasons Not Completed
Randomization
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 17, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel 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
BMS-986227, FPA008
Nab-paclitaxel
Drug
specified does on specified days
Arm A
Arm C
Abraxane
Onivyde
Drug
specified dose on specified days
Arm A
irinotecan liposome
Nivolumab
Biological
specified dose on specified days
Arm B
Arm C
Arm D
Opdivo, BMS-936558
Fluorouracil
Drug
specified dose on specified days
Arm A
Arm D
5-Fluorouracil
Gemcitabine
Drug
specified dose on specified days
Arm A
Arm C
Oxaliplatin
Drug
specified dose on specified day
Arm D
Leucovorin
Drug
Specified dose on specified days
Arm A
Arm D
Irinotecan Hydrochloride
Drug
Specified dose on specified days
Arm A
From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Progression Free Survival Rate (PFSR) by BICR
Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
At 6, 9, and 12 months
Progression Free Survival Rate (PFSR) by Investigator
Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
At 6, 9, and 12 months
Objective Response Rate (ORR) by BICR
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months)
Objective Response Rate (ORR) by Investigator
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months)
Duration of Response (DOR) by BICR
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
Duration of Response (DOR) by Investigator
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates.
From randomization to the date of death to any cause (up to approximately 65 months)
Overall Survival Rates (OSR)
Overall survival at 6 months, 1 year, and 2 years is defined as the percentage of participants who are alive at 6 months, 1 year, and 2 years. Based on Kaplan-Meier Estimates.
At 6 months, 1 year, and 2 years
The Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants Who Died
The number of participants that died during the study.
From first dose to 150 days after last dose of study therapy (up to approximately 53 months)
The Number of Participants Who Experienced Abnormal Hepatic Tests
The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests
The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN) Upper Limit of Normal (ULN)
From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Median
95% Confidence Interval
Months
From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Median
95% Confidence Interval
Months
From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy
Secondary
Progression Free Survival Rate (PFSR) by BICR
Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Number
95% Confidence Interval
Percentage of participants
At 6, 9, and 12 months
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Progression Free Survival Rate (PFSR) by Investigator
Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Number
95% Confidence Interval
Percentage of participants
At 6, 9, and 12 months
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Number
95% Confidence Interval
Percentage of participants
From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
gemcitabine + nab-paclitaxel
5-Fluorouracil/Leucovorin/Irinotecan Liposome
OG001
Arm B: Cabiralizumab + Nivolumab
Secondary
Objective Response Rate (ORR) by Investigator
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Number
95% Confidence Interval
Percentage of participants
From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
gemcitabine + nab-paclitaxel
5-Fluorouracil/Leucovorin/Irinotecan Liposome
OG001
Arm B: Cabiralizumab + Nivolumab
Secondary
Duration of Response (DOR) by BICR
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR
Posted
Median
95% Confidence Interval
Months
From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
gemcitabine + nab-paclitaxel
5-Fluorouracil/Leucovorin/Irinotecan Liposome
OG001
Arm B: Cabiralizumab + Nivolumab
Secondary
Duration of Response (DOR) by Investigator
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR
Posted
Median
95% Confidence Interval
Months
From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
gemcitabine + nab-paclitaxel
5-Fluorouracil/Leucovorin/Irinotecan Liposome
OG001
Arm B: Cabiralizumab + Nivolumab
Secondary
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Median
95% Confidence Interval
Months
From randomization to the date of death to any cause (up to approximately 65 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Overall survival at 6 months, 1 year, and 2 years is defined as the percentage of participants who are alive at 6 months, 1 year, and 2 years. Based on Kaplan-Meier Estimates.
All Efficacy Participants: Randomized population with at least one dose of study drug.
Posted
Number
95% Confidence Interval
Percentage of participants
At 6 months, 1 year, and 2 years
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy
Participants receive Cabiralizumab 4MG/KG Q2W + Nivolumab 480 MG Q4W and Gemcitabine + Nab-paclitaxel D1, 8, and 15 Q4W.
OG003
Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy
Secondary
The Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
All treated participants: All participants who take at least one dose of study drug
Posted
Count of Participants
Participants
From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy
Participants receive Cabiralizumab 4MG/KG Q2W + Nivolumab 480 MG Q4W and Gemcitabine + Nab-paclitaxel D1, 8, and 15 Q4W.
OG003
Secondary
The Number of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
All treated participants: All participants who take at least one dose of study drug
Posted
Count of Participants
Participants
From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy
Participants receive Cabiralizumab 4MG/KG Q2W + Nivolumab 480 MG Q4W and Gemcitabine + Nab-paclitaxel D1, 8, and 15 Q4W.
Secondary
The Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
All treated participants: All participants who take at least one dose of study drug
Posted
Count of Participants
Participants
From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
ID
Title
Description
OG000
Arm A: Investigator Choice
Participants receive Investigator choice of chemotherapy:
Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy
Participants receive Cabiralizumab 4MG/KG Q2W + Nivolumab 480 MG Q4W and Gemcitabine + Nab-paclitaxel D1, 8, and 15 Q4W.
OG003
Time Frame
All-cause mortality was assessed from a participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 51 months)
Description
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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
Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy
Participants receive Investigator choice of chemotherapy:
- gemcitabine + nab-paclitaxel
19
26
11
21
19
21
EG001
Arm A2: Investigator Choice - 5 FU-Based Chemotherapy
Participants receive Investigator choice of chemotherapy:
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0008 affected21 at risk
EG0016 affected19 at risk
EG00222 affected49 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Oncologic complication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Cerebral ischaemia
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Cerebrovascular accident
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Dizziness
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Encephalopathy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Ischaemic stroke
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Neurotoxicity
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Seizure
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Syncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Transient ischaemic attack
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Confusional state
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Mental status changes
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Psychotic disorder
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Acute kidney injury
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Haematuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Urinary retention
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Capillary leak syndrome
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Deep vein thrombosis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Embolism
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Haematoma
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Hypotension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Hypovolaemic shock
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0009 affected21 at risk
EG0015 affected19 at risk
EG00213 affected49 at risk
EG00334 affected48 at risk
EG00417 affected42 at risk
Leukopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Cardiac failure congestive
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Tachycardia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Vertigo
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Hypothyroidism
Endocrine disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0022 affected49 at risk
EG003
Halo vision
Eye disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Periorbital oedema
Eye disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG00213 affected49 at risk
EG003
Vision blurred
Eye disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Visual impairment
Eye disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Vitreous floaters
Eye disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Abdominal distension
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0025 affected49 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0006 affected21 at risk
EG0014 affected19 at risk
EG00215 affected49 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0022 affected49 at risk
EG003
Ascites
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Constipation
Gastrointestinal disorders
26.0
Systematic Assessment
EG0007 affected21 at risk
EG0018 affected19 at risk
EG00213 affected49 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected19 at risk
EG0020 affected49 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0005 affected21 at risk
EG0019 affected19 at risk
EG00211 affected49 at risk
EG003
Dry mouth
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0025 affected49 at risk
EG003
Dyspepsia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0026 affected49 at risk
EG003
Enteritis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Flatulence
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0022 affected49 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Haematochezia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
26.0
Systematic Assessment
EG0003 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Lip dry
Gastrointestinal disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Nausea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0007 affected21 at risk
EG0019 affected19 at risk
EG00219 affected49 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Stomatitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0005 affected21 at risk
EG0012 affected19 at risk
EG0024 affected49 at risk
EG003
Vomiting
Gastrointestinal disorders
26.0
Systematic Assessment
EG0009 affected21 at risk
EG0017 affected19 at risk
EG00211 affected49 at risk
EG003
Asthenia
General disorders
26.0
Systematic Assessment
EG0003 affected21 at risk
EG0011 affected19 at risk
EG0023 affected49 at risk
EG003
Catheter site phlebitis
General disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Chills
General disorders
26.0
Systematic Assessment
EG0005 affected21 at risk
EG0012 affected19 at risk
EG0022 affected49 at risk
EG003
Face oedema
General disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0023 affected49 at risk
EG003
Facial pain
General disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Fatigue
General disorders
26.0
Systematic Assessment
EG00010 affected21 at risk
EG00110 affected19 at risk
EG00225 affected49 at risk
EG003
Generalised oedema
General disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Influenza like illness
General disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Mucosal inflammation
General disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0012 affected19 at risk
EG0020 affected49 at risk
EG003
Non-cardiac chest pain
General disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Oedema peripheral
General disorders
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Pain
General disorders
26.0
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Peripheral swelling
General disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Pyrexia
General disorders
26.0
Systematic Assessment
EG0006 affected21 at risk
EG0013 affected19 at risk
EG00212 affected49 at risk
EG003
Temperature intolerance
General disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Biliary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Candida infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0022 affected49 at risk
EG003
Endocarditis staphylococcal
Infections and infestations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Skin infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Urinary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0025 affected49 at risk
EG003
Contusion
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Fall
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0022 affected49 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Alanine aminotransferase decreased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Alanine aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0029 affected49 at risk
EG003
Amylase increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Aspartate aminotransferase decreased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Aspartate aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0003 affected21 at risk
EG0011 affected19 at risk
EG00214 affected49 at risk
EG003
Blood alkaline phosphatase increased
Investigations
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected19 at risk
EG0029 affected49 at risk
EG003
Blood bilirubin increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0025 affected49 at risk
EG003
Blood creatine phosphokinase increased
Investigations
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG00215 affected49 at risk
EG003
Blood creatinine increased
Investigations
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0027 affected49 at risk
EG003
Brain natriuretic peptide increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
International normalised ratio increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Lymphocyte count decreased
Investigations
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0013 affected19 at risk
EG0024 affected49 at risk
EG003
Neutrophil count decreased
Investigations
26.0
Systematic Assessment
EG0007 affected21 at risk
EG0014 affected19 at risk
EG0021 affected49 at risk
EG003
Neutrophil count increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Platelet count decreased
Investigations
26.0
Systematic Assessment
EG0007 affected21 at risk
EG0013 affected19 at risk
EG0021 affected49 at risk
EG003
Weight decreased
Investigations
26.0
Systematic Assessment
EG0003 affected21 at risk
EG0012 affected19 at risk
EG0025 affected49 at risk
EG003
White blood cell count decreased
Investigations
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0013 affected19 at risk
EG0022 affected49 at risk
EG003
White blood cell count increased
Investigations
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0007 affected21 at risk
EG0016 affected19 at risk
EG00211 affected49 at risk
EG003
Dehydration
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0012 affected19 at risk
EG0029 affected49 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0022 affected49 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0013 affected19 at risk
EG0023 affected49 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0012 affected19 at risk
EG0022 affected49 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0018 affected19 at risk
EG0028 affected49 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0012 affected19 at risk
EG0024 affected49 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0012 affected19 at risk
EG0027 affected49 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected19 at risk
EG0025 affected49 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0012 affected19 at risk
EG0024 affected49 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0013 affected19 at risk
EG0029 affected49 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0022 affected49 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0022 affected49 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Balance disorder
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Dizziness
Nervous system disorders
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0012 affected19 at risk
EG0023 affected49 at risk
EG003
Dysgeusia
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0012 affected19 at risk
EG0024 affected49 at risk
EG003
Headache
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0013 affected19 at risk
EG0026 affected49 at risk
EG003
Neuropathy peripheral
Nervous system disorders
26.0
Systematic Assessment
EG0006 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Polyneuropathy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Presyncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Anxiety
Psychiatric disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Depression
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0023 affected49 at risk
EG003
Insomnia
Psychiatric disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0027 affected49 at risk
EG003
Somnambulism
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Haematuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Proteinuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0021 affected49 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0012 affected19 at risk
EG0023 affected49 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0012 affected19 at risk
EG0023 affected49 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected19 at risk
EG0021 affected49 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected19 at risk
EG0024 affected49 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected19 at risk
EG0021 affected49 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0009 affected21 at risk
EG0012 affected19 at risk
EG0025 affected49 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0013 affected19 at risk
EG0021 affected49 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0020 affected49 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected19 at risk
EG0020 affected49 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected19 at risk
EG0028 affected49 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0004 affected21 at risk
EG0011 affected19 at risk
EG00211 affected49 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected19 at risk
EG0027 affected49 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Deep vein thrombosis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Hot flush
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0021 affected49 at risk
EG003
Hypertension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0028 affected49 at risk
EG003
Thrombophlebitis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected19 at risk
EG0020 affected49 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.