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A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650) (CheckMate 650)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Cabazitaxel
Prednisone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
  • Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

  • Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

Exclusion Criteria:

  • Presence of visceral metastases in the liver
  • Active brain metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease or infection
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

  • Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
  • Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0074
  • Local Institution - 0046
  • Local Institution - 0011
  • Local Institution - 0076
  • Local Institution - 0008
  • Local Institution - 0075
  • Local Institution - 0078
  • Local Institution - 0065
  • Local Institution - 0001
  • Local Institution - 0077
  • Local Institution - 0047
  • Local Institution - 0010
  • Local Institution - 0067
  • Local Institution - 0079
  • Local Institution - 0002
  • Local Institution - 0027
  • Local Institution - 0059
  • Local Institution - 0029
  • Local Institution - 0028
  • Local Institution - 0043
  • Local Institution - 0030
  • Local Institution - 0031
  • Local Institution - 0048
  • Local Institution
  • Local Institution - 0044
  • Local Institution - 0062
  • Local Institution - 0063
  • Local Institution - 0061
  • Local Institution - 0060
  • Local Institution - 0009
  • Local Institution - 0005
  • Local Institution - 0004
  • Local Institution - 0003
  • Local Institution - 0041
  • Local Institution - 0032
  • Local Institution - 0038
  • Local Institution - 0019
  • Local Institution - 0017
  • Local Institution - 0018
  • Local Institution - 0034
  • Local Institution - 0037
  • Local Institution - 0042
  • Local Institution - 0036
  • Local Institution - 0033
  • Local Institution - 0035
  • Local Institution - 0071
  • Local Institution - 0052
  • Local Institution - 0053
  • Local Institution - 0072
  • Local Institution - 0051
  • Local Institution - 0055
  • Local Institution - 0066
  • Local Institution - 0054
  • Local Institution - 0026
  • Local Institution - 0025
  • Local Institution - 0020
  • Local Institution - 0022
  • Local Institution - 0021
  • Local Institution - 0024
  • Local Institution - 0023

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A (Arm A)

Cohort B (Arm B)

Cohort C (Arm C)

Cohort D (Arm D1)

Cohort D (Arm D2)

Cohort D (Arm D3)

Cohort D (Arm D4)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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 Bone disease progression by Prostate Cancer Working Group (PCWG2) 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.
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 Bone disease progression by (Prostate Cancer Working Group) PCWG2 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.

Secondary Outcome Measures

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: Bone disease progression by Prostate Cancer Working Group (PCWG2) Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: Need for palliative radiation therapy involving more than one site, OR Surgery of kyphoplasty to any neoplastic lesion, OR 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.
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: Bone disease progression by Prostate Cancer Working Group (PCWG2) Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: Need for palliative radiation therapy involving more than one site, OR Surgery of kyphoplasty to any neoplastic lesion, OR 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The Number of Participants Who Died in Cohorts A, B and C
Death due to any cause.
The Number of Participants Who Died in Cohort D
Death due to any cause.
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.
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.
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
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
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
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
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.
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.
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.
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.
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.

Full Information

First Posted
November 22, 2016
Last Updated
September 22, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02985957
Brief Title
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Acronym
CheckMate 650
Official Title
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2017 (Actual)
Primary Completion Date
April 5, 2022 (Actual)
Study Completion Date
October 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A (Arm A)
Arm Type
Experimental
Arm Title
Cohort B (Arm B)
Arm Type
Experimental
Arm Title
Cohort C (Arm C)
Arm Type
Experimental
Arm Title
Cohort D (Arm D1)
Arm Type
Experimental
Arm Title
Cohort D (Arm D2)
Arm Type
Experimental
Arm Title
Cohort D (Arm D3)
Arm Type
Experimental
Arm Title
Cohort D (Arm D4)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Cohorts B and C Per BICR
Description
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)
Title
Objective Response Rate (ORR) Cohort D
Description
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)
Title
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
Description
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 Bone disease progression by Prostate Cancer Working Group (PCWG2) 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)
Title
Radiographic Progression-Free Survival (rPFS) for Cohort D
Description
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 Bone disease progression by (Prostate Cancer Working Group) PCWG2 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)
Secondary Outcome Measure Information:
Title
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
Description
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: Bone disease progression by Prostate Cancer Working Group (PCWG2) Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: Need for palliative radiation therapy involving more than one site, OR Surgery of kyphoplasty to any neoplastic lesion, OR 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)
Title
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
Description
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: Bone disease progression by Prostate Cancer Working Group (PCWG2) Non-bone soft tissue disease progression by RECIST v1.1 Clinical progression per investigator assessment: Need for palliative radiation therapy involving more than one site, OR Surgery of kyphoplasty to any neoplastic lesion, OR 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 61 months)
Title
Overall Survival (OS) Cohorts B and C
Description
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)
Title
Overall Survival (OS) Cohort D
Description
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 61 months)
Title
Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
Description
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)
Title
Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
Description
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 61 months)
Title
The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
Description
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)
Title
The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
Description
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 4.83 months assessed up to approximately 26.5 months)
Title
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
Description
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)
Title
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
Description
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 4.83 months assessed up to approximately 26.5 months)
Title
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
Description
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)
Title
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
Description
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 4.83 months assessed up to approximately 26.5 months)
Title
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Description
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)
Title
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Description
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 4.83 months assessed up to approximately 29.5 months).
Title
The Number of Participants Who Died in Cohorts A, B and C
Description
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).
Title
The Number of Participants Who Died in Cohort D
Description
Death due to any cause.
Time Frame
From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).
Title
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Description
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)
Title
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Description
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 4.83 months assessed up to approximately 26.5 months)
Title
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
Description
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)
Title
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
Description
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 4.83 months assessed up to approximately 26.5 months)
Title
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
Description
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)
Title
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
Description
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 4.83 months assessed up to approximately 26.5 months)
Title
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Description
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)
Title
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Description
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.
Title
Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
Description
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.
Title
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
Description
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.
Title
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI). Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL) For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization Exclusion Criteria: Presence of visceral metastases in the liver Active brain metastases or leptomeningeal metastases Active, known, or suspected autoimmune disease or infection Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel) Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0074
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Local Institution - 0046
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution - 0011
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Local Institution - 0076
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Local Institution - 0008
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0075
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Local Institution - 0078
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Local Institution - 0065
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Local Institution - 0001
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 0077
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Local Institution - 0047
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Local Institution - 0010
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0067
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0079
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Local Institution - 0002
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0027
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Local Institution - 0059
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Local Institution - 0029
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0028
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution - 0043
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4012
Country
Australia
Facility Name
Local Institution - 0030
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Local Institution - 0031
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 0048
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution - 0044
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Local Institution - 0062
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Local Institution - 0063
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Local Institution - 0061
City
Kobenhavn O
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution - 0060
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution - 0009
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Local Institution - 0005
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Local Institution - 0004
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution - 0003
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution - 0041
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Local Institution - 0032
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 0038
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution - 0019
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Local Institution - 0017
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution - 0018
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution - 0034
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution - 0037
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Local Institution - 0042
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Local Institution - 0036
City
Rostock
ZIP/Postal Code
18107
Country
Germany
Facility Name
Local Institution - 0033
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0035
City
Wesel
ZIP/Postal Code
46483
Country
Germany
Facility Name
Local Institution - 0071
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Local Institution - 0052
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0053
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0072
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Local Institution - 0051
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution - 0055
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Local Institution - 0066
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Local Institution - 0054
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0026
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Local Institution - 0025
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution - 0020
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0022
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Local Institution - 0021
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0024
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0023
City
Santiago Compostela
ZIP/Postal Code
15706
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32916128
Citation
Sharma P, Pachynski RK, Narayan V, Flechon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

Learn more about this trial

A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)

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