Advanced Pancreatic Cancer
Conditions
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.
Interventions
BIOLOGICALCabiralizumab
specified dose on specified days
DRUGNab-paclitaxel
specified does on specified days
DRUGOnivyde
specified dose on specified days
BIOLOGICALNivolumab
specified dose on specified days
DRUGFluorouracil
specified dose on specified days
DRUGGemcitabine
specified dose on specified days
DRUGOxaliplatin
specified dose on specified day
DRUGLeucovorin
Specified dose on specified days
DRUGIrinotecan Hydrochloride
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) by BICR | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival Rate (PFSR) by BICR | At 6, 9, and 12 months | 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. |
| Progression Free Survival Rate (PFSR) by Investigator | At 6, 9, and 12 months | 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. |
| Objective Response Rate (ORR) by BICR | 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) | 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. |
| Objective Response Rate (ORR) by Investigator | 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) | 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. |
| Duration of Response (DOR) by BICR | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | 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. |
| The Number of Participants Who Experienced Abnormal Hepatic Tests | From first dose and 100 days after last dose of study therapy (up to approximately 51 months) | 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) |
| Duration of Response (DOR) by Investigator | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | 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. |
| Progression Free Survival (PFS) by Investigator | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 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. |
| Overall Survival Rates (OSR) | At 6 months, 1 year, and 2 years | 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. |
| The Number of Participants With Adverse Events (AEs) | From first dose to 100 days after last dose of study therapy (up to approximately 51 months) | 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. |
| The Number of Participants With Serious Adverse Events (SAEs) | From first dose to 100 days after last dose of study therapy (up to approximately 51 months) | 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. |
| The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days after last dose of study therapy (up to approximately 51 months) | 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. |
| The Number of Participants Who Died | From first dose to 150 days after last dose of study therapy (up to approximately 53 months) | The number of participants that died during the study. |
| The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | From first dose and 100 days after last dose of study therapy (up to approximately 51 months) | 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) |
| Overall Survival (OS) | From randomization to the date of death to any cause (up to approximately 65 months) | OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates. |
Countries
Canada, Denmark, Germany, Italy, Japan, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Investigator Choice Participants receive Investigator choice of chemotherapy:
* gemcitabine + nab-paclitaxel
* 5-Fluorouracil/Leucovorin/Irinotecan Liposome | 54 |
| Arm B: Cabiralizumab + Nivolumab Participants receive Cabiralizumab 4MG/KG Q2W + Nivolumab 480 MG Q4W. | 54 |
| 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. | 54 |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy Participants receive Cabiralizumab 4MG/KG Q2W + Nivolumab 480 MG Q4W and Oxaliplatin/5-Fluorouracil/Leucovorin Q2W. | 43 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Randomization | Adverse Event | 1 | 1 | 0 | 0 |
| Randomization | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Randomization | Not reported | 2 | 0 | 1 | 0 |
| Randomization | Other reasons | 1 | 1 | 1 | 0 |
| Randomization | Participant no longer meets study criteria | 0 | 2 | 4 | 1 |
| Randomization | Participant withdrew consent | 9 | 1 | 0 | 0 |
| Treatment | Adverse Event | 2 | 3 | 4 | 4 |
| Treatment | Adverse Event unrelated to study drug | 1 | 1 | 1 | 0 |
| Treatment | Death | 2 | 3 | 3 | 4 |
| Treatment | Disease progression | 23 | 34 | 33 | 26 |
| Treatment | Disease Recurrence | 1 | 0 | 0 | 0 |
| Treatment | Other reasons | 2 | 0 | 0 | 3 |
| Treatment | Participant no longer meets study criteria | 0 | 1 | 0 | 0 |
| Treatment | Participant request to discontinue treatment | 2 | 1 | 2 | 2 |
| Treatment | Participant withdrew consent | 7 | 2 | 3 | 2 |
| Treatment | Study drug toxicity | 0 | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.7 Years STANDARD_DEVIATION 8.6 | 64.2 Years STANDARD_DEVIATION 9.1 | 59.1 Years STANDARD_DEVIATION 9.7 | 64.2 Years STANDARD_DEVIATION 9.6 | 62.4 Years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 48 Participants | 45 Participants | 41 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 8 Participants | 2 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 8 Participants | 8 Participants | 12 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 1 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 40 Participants | 43 Participants | 45 Participants | 27 Participants | 155 Participants |
| Sex: Female, Male Female | 26 Participants | 28 Participants | 26 Participants | 26 Participants | 106 Participants |
| Sex: Female, Male Male | 28 Participants | 26 Participants | 28 Participants | 17 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 26 | 17 / 28 | 49 / 54 | 49 / 54 | 40 / 43 |
| other Total, other adverse events | 19 / 21 | 17 / 19 | 46 / 49 | 47 / 48 | 41 / 42 |
| serious Total, serious adverse events | 11 / 21 | 12 / 19 | 41 / 49 | 39 / 48 | 33 / 42 |
Outcome results
Primary
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.
Time frame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Investigator Choice | Progression Free Survival (PFS) by BICR | 3.52 Months |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival (PFS) by BICR | 1.92 Months |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival (PFS) by BICR | 3.68 Months |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival (PFS) by BICR | 3.22 Months |
60% CI: [1.19, 1.82]
60% CI: [0.77, 1.3]
60% CI: [0.6, 1.03]
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.
Time frame: From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
Population: All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Investigator Choice | Duration of Response (DOR) by BICR | NA Months |
| Arm B: Cabiralizumab + Nivolumab | Duration of Response (DOR) by BICR | 4.2 Months |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Duration of Response (DOR) by BICR | 4.6 Months |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Duration of Response (DOR) by BICR | NA Months |
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.
Time frame: From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
Population: All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Investigator Choice | Duration of Response (DOR) by Investigator | 10.2 Months |
| Arm B: Cabiralizumab + Nivolumab | Duration of Response (DOR) by Investigator | 7.3 Months |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Duration of Response (DOR) by Investigator | NA Months |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Duration of Response (DOR) by Investigator | NA Months |
Secondary
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.
Time frame: 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)
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Investigator Choice | Objective Response Rate (ORR) by BICR | 2.5 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Objective Response Rate (ORR) by BICR | 4.1 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Objective Response Rate (ORR) by BICR | 12.5 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Objective Response Rate (ORR) by BICR | 9.5 Percentage of participants |
p-value: 0.653795% CI: [-5.5, 9]Cochran-Mantel-Haenszel
p-value: 0.095195% CI: [3.1, 21.9]Cochran-Mantel-Haenszel
p-value: 0.517195% CI: [-8, 18.1]Cochran-Mantel-Haenszel
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.
Time frame: 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)
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Investigator Choice | Objective Response Rate (ORR) by Investigator | 5.0 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Objective Response Rate (ORR) by Investigator | 4.1 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Objective Response Rate (ORR) by Investigator | 6.3 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Objective Response Rate (ORR) by Investigator | 4.8 Percentage of participants |
p-value: 0.850595% CI: [-9.4, 7.7]Cochran-Mantel-Haenszel
p-value: 0.814495% CI: [-9.9, 12.8]Cochran-Mantel-Haenszel
p-value: 0.908795% CI: [-10.7, 12.1]Cochran-Mantel-Haenszel
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.
Time frame: From randomization to the date of death to any cause (up to approximately 65 months)
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Investigator Choice | Overall Survival (OS) | 6.28 Months |
| Arm B: Cabiralizumab + Nivolumab | Overall Survival (OS) | 4.44 Months |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Overall Survival (OS) | 6.72 Months |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Overall Survival (OS) | 5.68 Months |
95% CI: [0.76, 1.96]
95% CI: [0.59, 1.86]
95% CI: [0.45, 1.46]
Secondary
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.
Time frame: At 6 months, 1 year, and 2 years
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Investigator Choice | Overall Survival Rates (OSR) | 24-MONTH | NA Percentage of participants |
| Arm A: Investigator Choice | Overall Survival Rates (OSR) | 6-MONTH | 55.8 Percentage of participants |
| Arm A: Investigator Choice | Overall Survival Rates (OSR) | 12-MONTH | 14.7 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Overall Survival Rates (OSR) | 12-MONTH | 20.1 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Overall Survival Rates (OSR) | 6-MONTH | 40.1 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Overall Survival Rates (OSR) | 24-MONTH | NA Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Overall Survival Rates (OSR) | 24-MONTH | NA Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Overall Survival Rates (OSR) | 6-MONTH | 54.2 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Overall Survival Rates (OSR) | 12-MONTH | 20.6 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Overall Survival Rates (OSR) | 12-MONTH | 17.4 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Overall Survival Rates (OSR) | 6-MONTH | 44.8 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Overall Survival Rates (OSR) | 24-MONTH | NA Percentage of participants |
Secondary
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.
Time frame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Investigator Choice | Progression Free Survival (PFS) by Investigator | 3.38 Months |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival (PFS) by Investigator | 1.81 Months |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival (PFS) by Investigator | 3.68 Months |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival (PFS) by Investigator | 2.92 Months |
60% CI: [1.33, 2.02]
60% CI: [0.87, 1.46]
60% CI: [0.55, 0.94]
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.
Time frame: At 6, 9, and 12 months
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Investigator Choice | Progression Free Survival Rate (PFSR) by BICR | 12-MONTH | NA Percentage of participants |
| Arm A: Investigator Choice | Progression Free Survival Rate (PFSR) by BICR | 6-MONTH | 15.5 Percentage of participants |
| Arm A: Investigator Choice | Progression Free Survival Rate (PFSR) by BICR | 9-MONTH | 5.2 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival Rate (PFSR) by BICR | 6-MONTH | 13.1 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival Rate (PFSR) by BICR | 12-MONTH | 2.2 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival Rate (PFSR) by BICR | 9-MONTH | 6.5 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival Rate (PFSR) by BICR | 9-MONTH | 9.5 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival Rate (PFSR) by BICR | 6-MONTH | 21.7 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival Rate (PFSR) by BICR | 12-MONTH | 3.2 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival Rate (PFSR) by BICR | 6-MONTH | 17.7 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival Rate (PFSR) by BICR | 12-MONTH | 5.1 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival Rate (PFSR) by BICR | 9-MONTH | 10.1 Percentage of participants |
Secondary
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.
Time frame: At 6, 9, and 12 months
Population: All Efficacy Participants: Randomized population with at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Investigator Choice | Progression Free Survival Rate (PFSR) by Investigator | 12-MONTH | 3.7 Percentage of participants |
| Arm A: Investigator Choice | Progression Free Survival Rate (PFSR) by Investigator | 9-MONTH | 11.2 Percentage of participants |
| Arm A: Investigator Choice | Progression Free Survival Rate (PFSR) by Investigator | 6-MONTH | 14.9 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival Rate (PFSR) by Investigator | 12-MONTH | NA Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival Rate (PFSR) by Investigator | 9-MONTH | 8.2 Percentage of participants |
| Arm B: Cabiralizumab + Nivolumab | Progression Free Survival Rate (PFSR) by Investigator | 6-MONTH | 16.3 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival Rate (PFSR) by Investigator | 6-MONTH | 17.6 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival Rate (PFSR) by Investigator | 9-MONTH | 5.0 Percentage of participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Progression Free Survival Rate (PFSR) by Investigator | 12-MONTH | 2.5 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival Rate (PFSR) by Investigator | 12-MONTH | 4.9 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival Rate (PFSR) by Investigator | 9-MONTH | 7.3 Percentage of participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Progression Free Survival Rate (PFSR) by Investigator | 6-MONTH | 14.7 Percentage of participants |
Secondary
The Number of Participants Who Died
The number of participants that died during the study.
Time frame: From first dose to 150 days after last dose of study therapy (up to approximately 53 months)
Population: All treated participants: All participants who take at least one dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Investigator Choice | The Number of Participants Who Died | 25 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Died | 33 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Died | 30 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Died | 28 Participants |
Secondary
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)
Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
Population: All treated participants with at least one on-treatment hepatic measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 3xULN | 2 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 5xULN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 10xULN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 12xULN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 20xULN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | TOTAL BILIRUBIN > 2xULN | 3 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALP > 1.5xULN | 27 Participants |
| Arm A: Investigator Choice | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT/AST > 3xULN; TOTAL BILIRUBIN > 2xULN and ALP <=2ULN IN 3 DAYS | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | TOTAL BILIRUBIN > 2xULN | 3 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 20xULN | 1 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 5xULN | 10 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT/AST > 3xULN; TOTAL BILIRUBIN > 2xULN and ALP <=2ULN IN 3 DAYS | 1 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALP > 1.5xULN | 31 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 12xULN | 2 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 10xULN | 2 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 3xULN | 21 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALP > 1.5xULN | 35 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 10xULN | 6 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 12xULN | 4 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 20xULN | 1 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | TOTAL BILIRUBIN > 2xULN | 2 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT/AST > 3xULN; TOTAL BILIRUBIN > 2xULN and ALP <=2ULN IN 3 DAYS | 1 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 3xULN | 37 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 5xULN | 19 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 10xULN | 2 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 12xULN | 2 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 5xULN | 18 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 3xULN | 34 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT or AST > 20xULN | 1 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALT/AST > 3xULN; TOTAL BILIRUBIN > 2xULN and ALP <=2ULN IN 3 DAYS | 1 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | ALP > 1.5xULN | 30 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants Who Experienced Abnormal Hepatic Tests | TOTAL BILIRUBIN > 2xULN | 5 Participants |
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.
Time frame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
Population: All treated participants: All participants who take at least one dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Investigator Choice | The Number of Participants With Adverse Events (AEs) | 40 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With Adverse Events (AEs) | 49 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With Adverse Events (AEs) | 48 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With Adverse Events (AEs) | 42 Participants |
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.
Time frame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
Population: All treated participants: All participants who take at least one dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Investigator Choice | The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 6 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 11 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 11 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 8 Participants |
Secondary
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)
Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
Population: All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 3 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER T3/T4 TEST VALUES <= ULN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE T3/T4 TEST VALUE < LLN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL T3/T4 TEST VALUES >= LLN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm A: Investigator Choice | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE T3/T4 TEST VALUE > ULN | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 4 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER T3/T4 TEST VALUES <= ULN | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE T3/T4 TEST VALUE < LLN | 1 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE T3/T4 TEST VALUE > ULN | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH T3/T4 TEST MISSING | 1 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL T3/T4 TEST VALUES >= LLN | 0 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 1 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL T3/T4 TEST VALUES >= LLN | 0 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE T3/T4 TEST VALUE > ULN | 0 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER T3/T4 TEST VALUES <= ULN | 0 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 10 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 4 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE T3/T4 TEST VALUE < LLN | 1 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH ALL T3/T4 TEST VALUES >= LLN | 0 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 6 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 1 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH AT LEAST ONE T3/T4 TEST VALUE < LLN | 0 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH ALL OTHER T3/T4 TEST VALUES <= ULN | 0 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH T3/T4 TEST MISSING | 0 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN WITH AT LEAST ONE T3/T4 TEST VALUE > ULN | 0 Participants |
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.
Time frame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
Population: All treated participants: All participants who take at least one dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Investigator Choice | The Number of Participants With Serious Adverse Events (SAEs) | 23 Participants |
| Arm B: Cabiralizumab + Nivolumab | The Number of Participants With Serious Adverse Events (SAEs) | 41 Participants |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | The Number of Participants With Serious Adverse Events (SAEs) | 39 Participants |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | The Number of Participants With Serious Adverse Events (SAEs) | 33 Participants |