A Phase 2 interventional study of Nivolumab and Ipilimumab in Prostate Cancer, sponsored by Bristol-Myers Squibb. Completed at 59 sites in 10 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).
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This study's enrollment of 351 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
Exclusion Criteria:
For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
Other protocol-defined inclusion/exclusion criteria apply
Biological: Nivolumab · Biological: Ipilimumab
Biological: Nivolumab · Biological: Ipilimumab
Biological: Nivolumab · Biological: Ipilimumab
Biological: Nivolumab · Biological: Ipilimumab
Biological: Nivolumab · Biological: Ipilimumab
Biological: Ipilimumab
Drug: Cabazitaxel · Drug: Prednisone
Specified dose on specified days
Also known as: BMS-936558, Opdivo
Specified dose on specified days
Also known as: BMS-734016, Yervoy
Specified dose on specified days
Specified dose on specified days
Objective Response Rate (ORR) Cohorts B and C Per BICR
Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
Time frame: From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Objective Response Rate (ORR) Cohort D
In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
Time frame: From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on 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 (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Time frame: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Radiographic Progression-Free Survival (rPFS) for Cohort D
Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per BICR assessment 1. Bone disease progression by (Prostate Cancer Working Group) PCWG2 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on 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 (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Time frame: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first. Radiographic progression per Investigator assessment: 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: 1. Need for palliative radiation therapy involving more than one site, OR 2. Surgery of kyphoplasty to any neoplastic lesion, OR 3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Time frame: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first. Radiographic progression per Investigator assessment: 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: 1. Need for palliative radiation therapy involving more than one site, OR 2. Surgery of kyphoplasty to any neoplastic lesion, OR 3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
Time frame: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)
Overall Survival (OS) Cohorts B and C
Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up. Based on Kaplan-Meier estimates.
Time frame: From first dose to the date of death due to any cause (assessed up to approximately 61 months)
Overall Survival (OS) Cohort D
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up. Based on Kaplan-Meier estimates.
Time frame: From randomization to the date of death due to any cause (assessed up to approximately 93 months)
Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. Confidence-interval based on Clopper Pearson method.
Time frame: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. Confidence-interval based on Clopper Pearson method.
Time frame: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 93 months)
The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
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 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
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 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
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 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
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 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Time frame: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Time frame: From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)
The Number of Participants Who Died in Cohorts A, B and C
Death due to any cause.
Time frame: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).
The Number of Participants Who Died in Cohort D
Death due to any cause.
Time frame: From first dose to 100 days after last dose of study therapy (an average of 8.48 months assessed up to approximately 29.09 months)
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.
Time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
The number of participants with an change in laboratory values from baseline Grade in Cohort D.
Time frame: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time frame: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Time frame: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Time frame: From first dose to 30 days after last dose of study therapy (an average of 6.19 months assessed up to approximately 26.8 months)
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Time frame: At baseline and Week 4 (Cycle 2)
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Time frame: At baseline and 4 weeks after first dose.
Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.
Time frame: At baseline and 4 weeks after first dose.
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Time frame: At baseline and at Week 4 of Cycle 2.
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
Time frame: At baseline and 4 weeks after first dose.
Cohort A: Asymptomatic or minimally symptomatic, not previously received second generation hormone therapies or cytotoxic chemotherapy. Cohort B: Asymptomatic or minimally symptomatic, progressed after second generation hormone therapies and had not been treated with cytotoxic chemotherapy. Cohort C: Progressed after prior taxane-based cytotoxic chemotherapy. Cohort D: Progressed after prior docetaxel-containing therapy.
| Milestone | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|---|---|---|
| Started | 2 | 45 | 45 | 73 | 74 | 38 | 74 |
| Completed | 2 | 45 | 45 | 73 | 73 | 38 | 72 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Withdrew: Participant no longer meets study criteria | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Participant withdrew consent | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event unrelated to study drug | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|---|---|---|
| Started | 2 | 45 | 45 | 73 | 73 | 38 | 72 |
| Eligible participants who progressed and received nivolumab 3 mg/kg + ipilimumab 1 mg/kg | 0 | 0 | 0 | 0 | 0 | 13 | 27 |
| Completed | 0 | 0 | 0 | 5 | 3 | 19 | 25 |
| Not completed | 2 | 45 | 45 | 68 | 70 | 19 | 47 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Participant withdrew consent | 0 | 0 | 0 | 1 | 3 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Other reasons | 0 | 0 | 1 | 3 | 5 | 0 | 1 |
| Withdrew: Not reported | 0 | 2 | 2 | 5 | 0 | 0 | 0 |
| Withdrew: Maximum clinical benefit | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Withdrew: Adverse event unrelated to study drug | 1 | 4 | 1 | 2 | 8 | 2 | 7 |
| Withdrew: Study drug toxicity | 1 | 23 | 20 | 12 | 20 | 3 | 5 |
| Withdrew: Disease progression | 0 | 16 | 20 | 40 | 29 | 11 | 28 |
| Withdrew: Participant request to discontinue study treatment | 0 | 0 | 0 | 4 | 2 | 2 | 3 |
| Withdrew: Poor/non-compliance | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
| Percent of Participants | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Objective Response Rate (ORR) Cohorts B and C Per BICR | 12.5 (3.5 to 29.0) | 20.0 (7.7 to 38.6) |
In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
| Percent of Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Objective Response Rate (ORR) Cohort D | 8.9 (2.5 to 21.2) | 15.2 (6.3 to 28.9) | 4.3 (0.1 to 21.9) | 11.1 (3.7 to 24.1) |
Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on 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 (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
| Months | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR | 7.59 (3.65 to 10.22) | 5.36 (2.92 to 7.66) |
Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per BICR assessment 1. Bone disease progression by (Prostate Cancer Working Group) PCWG2 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on 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 (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
| Months | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Radiographic Progression-Free Survival (rPFS) for Cohort D | 3.94 (2.17 to 7.62) | 4.17 (3.32 to 5.59) | 3.48 (2.14 to 5.78) | 7.92 (5.55 to 9.33) |
Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first. Radiographic progression per Investigator assessment: 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: 1. Need for palliative radiation therapy involving more than one site, OR 2. Surgery of kyphoplasty to any neoplastic lesion, OR 3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
| Months | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C | 4.34 (2.79 to 5.49) | 3.71 (2.10 to 4.04) |
Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first. Radiographic progression per Investigator assessment: 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: 1. Need for palliative radiation therapy involving more than one site, OR 2. Surgery of kyphoplasty to any neoplastic lesion, OR 3. Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
| Months | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D | 2.53 (2.10 to 3.22) | 3.78 (2.23 to 4.63) | 2.66 (2.04 to 3.71) | 5.85 (3.84 to 7.52) |
Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up. Based on Kaplan-Meier estimates.
| Months | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Overall Survival (OS) Cohorts B and C | 19.75 (13.90 to 23.56) | 15.21 (8.44 to 17.77) |
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up. Based on Kaplan-Meier estimates.
| Months | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Overall Survival (OS) Cohort D | 15.9 (13.14 to 19.29) | 14.46 (10.64 to 17.51) | 18.46 (10.28 to 25.69) | 15.15 (11.56 to 18.56) |
The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. Confidence-interval based on Clopper Pearson method.
| Percent of Participants | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C | 17.6 (6.8 to 34.5) | 10.0 (2.8 to 23.7) |
The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. Confidence-interval based on Clopper Pearson method.
| Percent of Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|
| Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D | 13.6 (6.4 to 24.3) | 18.2 (9.8 to 29.6) | 5.4 (0.7 to 18.2) | 23.9 (14.6 to 35.5) | 30.8 (9.1 to 61.4) | 17.4 (5.0 to 38.8) |
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C | 2 | 45 | 45 |
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|
| The Number of Participants Experiencing Adverse Events (AEs) in Cohort D | 69 | 71 | 37 | 69 | 11 | 27 |
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.
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C | 1 | 17 | 33 |
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.
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|
| The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D | 38 | 44 | 15 | 32 | 7 | 18 |
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.
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C | 1 | 17 | 18 |
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.
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|
| The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D | 16 | 27 | 7 | 13 | 3 | 6 |
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| Pneumonitis | 1 | 3 | 2 |
| Diarrhea/Colitis | 0 | 15 | 17 |
| Hepatitis | 0 | 4 | 1 |
| Adrenal Insufficiency | 0 | 1 | 2 |
| Hypothyroidism/Thyroiditis | 0 | 2 | 1 |
| Diabetes Mellitus | 0 | 0 | 0 |
| Nephritis and Renal Dysfunction | 0 | 1 | 0 |
| Rash | 0 | 16 | 6 |
| Hypersensitivity | 0 | 0 | 0 |
| Hyperthyroidism | 0 | 1 | 1 |
| Hypophysitis | 0 | 3 | 1 |
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|
| Pneumonitis | 1 | 4 | 0 | 0 | 1 | 2 |
| Diarrhea/Colitis | 9 | 21 | 5 | 0 | 0 | 2 |
| Hepatitis | 5 | 8 | 0 | 0 | 0 | 2 |
| Adrenal Insufficiency | 2 | 3 | 1 | 0 | 2 | 1 |
| Hypothyroidism/Thyroiditis | 6 | 9 | 1 | 0 | 3 | 3 |
| Diabetes Mellitus | 1 | 1 | 0 | 0 | 0 | 1 |
| Nephritis and Renal Dysfunction | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash | 12 | 10 | 2 | 0 | 1 | 4 |
| Hypersensitivity | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyperthyroidism | 4 | 5 | 0 | 0 | 1 | 2 |
| Hypophysitis | 2 | 5 | 3 | 0 | 1 | 1 |
Death due to any cause.
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| The Number of Participants Who Died in Cohorts A, B and C | 2 | 39 | 39 |
Death due to any cause.
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|
| The Number of Participants Who Died in Cohort D | 14 | 15 | 4 | 13 | 2 | 9 |
The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C.
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| Hemoglobin | 0 | 6 | 23 |
| Platelet Count | 0 | 3 | 8 |
| Leukocytes | 0 | 1 | 7 |
| Lymphocytes (Absolute) | 0 | 9 | 17 |
| Absolute Neutrophil Count | 0 | 0 | 6 |
| Alkaline Phosphatase | 0 | 7 | 15 |
| Aspartate Aminotransferase | 0 | 9 | 17 |
| Alanine Aminotransferase | 1 | 5 | 14 |
| Bilirubin, Total | 0 | 3 | 0 |
| Creatinine | 0 | 5 | 8 |
| Amylase, Total | 0 | 8 | 6 |
| Lipase, Total | 0 | 6 | 3 |
| Hypernatremia | 0 | 1 | 0 |
| Hyponatremia | 0 | 8 | 15 |
| Hyperkalemia | 0 | 1 | 5 |
| Hypokalemia | 0 | 3 | 7 |
| Hypercalcemia | 0 | 0 | 0 |
| Hypocalcemia | 0 | 4 | 12 |
| Hyperglycemia | — | 0 | 2 |
| Hypoglycemia | — | 0 | 0 |
The number of participants with an change in laboratory values from baseline Grade in Cohort D.
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Hemoglobin | 26 | 35 | 14 | 42 |
| Platelet Count | 10 | 8 | 2 | 15 |
| Leukocytes | 8 | 9 | 3 | 25 |
| Lymphocytes (Absolute) | 28 | 31 | 9 | 37 |
| Absolute Neutrophil Count | 7 | 7 | 2 | 18 |
| Alkaline Phosphatase | 23 | 18 | 12 | 14 |
| Aspartate Aminotransferase | 17 | 21 | 5 | 11 |
| Alanine Aminotransferase | 21 | 24 | 3 | 6 |
| Bilirubin, Total | 3 | 1 | 0 | 3 |
| Creatinine | 20 | 15 | 2 | 14 |
| Amylase, Total | 13 | 16 | 1 | 3 |
| Lipase, Total | 17 | 16 | 7 | 8 |
| Hypernatremia | 4 | 4 | 1 | 3 |
| Hyponatremia | 21 | 12 | 7 | 12 |
| Hyperkalemia | 7 | 12 | 1 | 7 |
| Hypokalemia | 5 | 8 | 5 | 8 |
| Hypercalcemia | 2 | 7 | 2 | 1 |
| Hypocalcemia | 12 | 23 | 14 | 18 |
| Hyperglycemia | 1 | 9 | 3 | 5 |
| Hypoglycemia | 0 | 0 | 0 | 1 |
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| ALT OR AST > 3XULN | 0 | 2 | 5 |
| ALT OR AST> 5XULN | 0 | 2 | 2 |
| ALT OR AST> 10XULN | 0 | 2 | 1 |
| ALT OR AST > 20XULN | 0 | 2 | 1 |
| TOTAL BILIRUBIN > 2XULN | 0 | 2 | 0 |
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| ALT OR AST > 3XULN | 6 | 8 | 0 | 1 |
| ALT OR AST> 5XULN | 3 | 5 | 0 | 0 |
| ALT OR AST> 10XULN | 1 | 3 | 0 | 0 |
| ALT OR AST > 20XULN | 0 | 1 | 0 | 0 |
| TOTAL BILIRUBIN > 2XULN | 2 | 0 | 0 | 0 |
| ALP>1.5XULN | 23 | 24 | 15 | 17 |
| CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 1 DAY | 1 | 0 | 0 | 0 |
| CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 30 DAYS | 1 | 0 | 0 | 0 |
| CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 1 DAY | 1 | 0 | 0 | 0 |
| CONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 30 DAYS | 1 | 0 | 0 | 0 |
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
| Participants | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|---|
| TSH > ULN | 0 | 5 | 13 |
| TSH > ULN WITH TSH <= ULN AT BASELINE | 0 | 3 | 7 |
| TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 | 4 | 6 |
| TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 | 1 | 4 |
| TSH > ULN WITH FT3/FT4 TEST MISSING | 0 | 0 | 3 |
| TSH < LLN | 0 | 7 | 10 |
| TSH <LLN WITH TSH >= LLN AT BASELINE | 0 | 6 | 10 |
| TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 | 4 | 8 |
| TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 | 2 | 1 |
| TSH < LLN WITH FT3/FT4 TEST MISSING | 0 | 1 | 1 |
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
| Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| TSH > ULN | 13 | 20 | 1 | 11 |
| TSH > ULN WITH TSH <= ULN AT BASELINE | 10 | 16 | 1 | 6 |
| TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 6 | 12 | 0 | 3 |
| TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 6 | 7 | 1 | 5 |
| TSH > ULN WITH FT3/FT4 TEST MISSING | 1 | 1 | 0 | 3 |
| TSH < LLN | 22 | 22 | 7 | 6 |
| TSH <LLN WITH TSH >= LLN AT BASELINE | 22 | 20 | 6 | 5 |
| TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 9 | 9 | 1 | 3 |
| TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 13 | 11 | 5 | 3 |
| TSH < LLN WITH FT3/FT4 TEST MISSING | 0 | 2 | 1 | 0 |
Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
| Score on a scale | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Worst pain in the last 24 hours Week 4 (Cycle 2) | 0.0 (-4 to 5) | -0.1 (-5 to 6) |
| Least pain in the last 24 hours Week 4 (Cycle 2) | -0.5 (-3 to 1) | -0.1 (-3 to 3) |
| Average pain in the last 24 hours Week 4 (Cycle 2) | -0.2 (-3 to 2) | -0.1 (-4 to 2) |
| Current pain Week 4 (Cycle 2) | -0.1 (-3 to 2) | 0 (-5 to 4) |
Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a "worse" outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
| Score on a scale | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Worst pain in the last 24 hours Week 4 | -0.3 (-7 to 8) | 0.5 (-5 to 7) | -0.1 (-8 to 6) | -0.5 (-7 to 5) |
| Least pain in the last 24 hours Week 4 | -0.3 (-7 to 8) | 0.2 (-4 to 4) | 0.2 (-4 to 5) | -0.3 (-5 to 3) |
| Average pain in the last 24 hours Week 4 | -0.5 (-6 to 6) | 0.2 (-5 to 6) | -0.3 (-5 to 5) | -0.4 (-5 to 3) |
| Current pain Week 4 | -0.2 (-6 to 6) | 0.3 (-4 to 4) | -0.4 (-6 to 6) | -0.3 (-6 to 5) |
The Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a multidimensional, self-report Quality of Life (QoL) instrument designed for use with prostate cancer patients. It consists of 27 core items. The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which assesses patient function in 4 domains: Physical, Social/Family, Emotional, and Functional well-being. This is further supplemented by the Prostate Cancer Subscale (PCS), 12 disease-specific items to assess for prostate-related symptoms. Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores for each domain, a Trial Outcome Index which is based on the Physical and Functional well-being scales and the PCS as well as a total score which ranges from 0 to 156. Higher scores represent better QoL. Baseline evaluations or events were defined as those that occur before or on the date and time of the first dose of study treatment.
| Score on a scale | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D | 6.73 (-60.2 to 116.4) | -4.74 (-81.0 to 72.7) | -3.64 (-91.5 to 65) | -0.28 (-71.7 to 53.0) |
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
| Score on a scale | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg |
|---|---|---|
| Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C | 0.0083 (-0.311 to 0.275) | -0.0074 (-0.327 to 0.628) |
The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.
| Score on a scale | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D | 0.0032 (-0.736 to 0.791) | -0.0328 (-0.574 to 0.532) | 0.0113 (-0.532 to 0.463) | 0.0219 (-0.514 to 0.697) |
In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
| Percent of Participants | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Objective Response Rate (ORR) Cohort D | 13.3 (5.1 to 26.8) | 17.4 (7.8 to 31.4) | 8.7 (1.1 to 28.0) | 8.9 (2.5 to 21.2) |
Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per BICR assessment 1. Bone disease progression by (Prostate Cancer Working Group) PCWG2 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on 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 (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
| Months | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg |
|---|---|---|---|---|
| Radiographic Progression-Free Survival (rPFS) for Cohort D | 3.70 (2.37 to 5.36) | 3.81 (2.23 to 4.63) | 3.09 (2.04 to 4.37) | 6.34 (5.22 to 8.31) |
Collected over Participants will be assessed for All-Cause Mortality (ACM) from the date of their first dose of study therapy until study completion for Cohorts A, B and C and from randomization until study completion for Cohort D (assessed up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy for all Cohorts (assessed up to approximately 29.09 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 2/2 (100%) | 2/2 (100%) | 2/2 (100%) |
| Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 40/45 (88.9%) | 37/45 (82.2%) | 44/45 (97.8%) |
| Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 41/45 (91.1%) | 39/45 (86.7%) | 45/45 (100%) |
| Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | 67/73 (91.8%) | 44/73 (60.3%) | 66/73 (90.4%) |
| Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | 65/74 (87.8%) | 50/73 (68.5%) | 64/73 (87.7%) |
| Cohort D Arm 3: Ipilimumab 3 mg/kg | 28/38 (73.7%) | 25/38 (65.8%) | 37/38 (97.4%) |
| Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | 49/74 (66.2%) | 50/72 (69.4%) | 71/72 (98.6%) |
| Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | 9/13 (69.2%) | 9/13 (69.2%) | 10/13 (76.9%) |
| Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 | 21/27 (77.8%) | 20/27 (74.1%) | 25/27 (92.6%) |
| Event | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|---|---|---|
| Disseminated intravascular coagulationBlood and lymphatic system disorders | 1/2 | 0/45 | 0/45 | 0/73 | 0/73 | 0/38 | 0/72 | 0/13 | 0/27 |
| ThyroiditisEndocrine disorders | 1/2 | 1/45 | 0/45 | 0/73 | 0/73 | 0/38 | 0/72 | 0/13 | 0/27 |
| Neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/2 | 0/45 | 0/45 | 0/73 | 0/73 | 0/38 | 0/72 | 0/13 | 0/27 |
| Cerebral haemorrhageNervous system disorders | 1/2 | 0/45 | 0/45 | 0/73 | 1/73 | 0/38 | 0/72 | 0/13 | 0/27 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/2 | 2/45 | 1/45 | 1/73 | 0/73 | 1/38 | 2/72 | 1/13 | 2/27 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/2 | 0/45 | 3/45 | 11/73 | 8/73 | 3/38 | 18/72 | 2/13 | 6/27 |
| ColitisGastrointestinal disorders | 0/2 | 5/45 | 9/45 | 3/73 | 7/73 | 1/38 | 2/72 | 0/13 | 2/27 |
| DiarrhoeaGastrointestinal disorders | 0/2 | 2/45 | 7/45 | 5/73 | 6/73 | 2/38 | 4/72 | 0/13 | 2/27 |
| Adrenal insufficiencyEndocrine disorders | 0/2 | 2/45 | 1/45 | 0/73 | 0/73 | 2/38 | 0/72 | 2/13 | 0/27 |
| Atrial fibrillationCardiac disorders | 0/2 | 4/45 | 1/45 | 1/73 | 0/73 | 0/38 | 1/72 | 0/13 | 0/27 |
| Event | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D3 | Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D4 |
|---|---|---|---|---|---|---|---|---|---|
| AgitationPsychiatric disorders | 2/2 | 1/45 | 1/45 | 0/73 | 0/73 | 0/38 | 1/72 | 0/13 | 1/27 |
| FatigueGeneral disorders | 1/2 | 28/45 | 31/45 | 21/73 | 20/73 | 15/38 | 31/72 | 1/13 | 5/27 |
| Decreased appetiteMetabolism and nutrition disorders | 0/2 | 15/45 | 29/45 | 17/73 | 14/73 | 15/38 | 20/72 | 3/13 | 7/27 |
| DiarrhoeaGastrointestinal disorders | 0/2 | 23/45 | 28/45 | 24/73 | 26/73 | 15/38 | 24/72 | 4/13 | 5/27 |
| AnaemiaBlood and lymphatic system disorders | 1/2 | 13/45 | 14/45 | 10/73 | 15/73 | 9/38 | 26/72 | 4/13 | 6/27 |
| TachycardiaCardiac disorders | 1/2 | 0/45 | 3/45 | 1/73 | 2/73 | 2/38 | 2/72 | 1/13 | 1/27 |
| HypothyroidismEndocrine disorders | 1/2 | 6/45 | 9/45 | 5/73 | 9/73 | 3/38 | 4/72 | 2/13 | 3/27 |
| Vision blurredEye disorders | 1/2 | 2/45 | 5/45 | 1/73 | 2/73 | 1/38 | 3/72 | 1/13 | 0/27 |
| ConstipationGastrointestinal disorders | 1/2 | 17/45 | 15/45 | 13/73 | 7/73 | 11/38 | 20/72 | 1/13 | 4/27 |
| PyrexiaGeneral disorders | 1/2 | 9/45 | 14/45 | 7/73 | 6/73 | 6/38 | 8/72 | 1/13 | 4/27 |
| Age, Categorical(Participants) | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 15 | 21 | 25 | 23 | 16 | 23 | 124 |
| >=65 years | 1 | 30 | 24 | 48 | 51 | 22 | 51 | 227 |
| Sex: Female, Male(Participants) | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 2 | 45 | 45 | 73 | 74 | 38 | 74 | 351 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 3 |
| Not Hispanic or Latino | 2 | 40 | 40 | 53 | 56 | 28 | 51 | 270 |
| Unknown or Not Reported | 0 | 5 | 5 | 19 | 18 | 9 | 22 | 78 |
| Race/Ethnicity, Customized(Participants) | Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W | Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W | Cohort D Arm 3: Ipilimumab 3 mg/kg | Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg | Total |
|---|---|---|---|---|---|---|---|---|
| White | 2 | 33 | 37 | 70 | 72 | 32 | 67 | 313 |
| Black or African American | 0 | 6 | 3 | 2 | 2 | 5 | 6 | 24 |
| Other | 0 | 5 | 5 | 1 | 0 | 1 | 1 | 13 |
| Asian | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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