Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
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ClinicalTrials.gov Identifier: NCT02985957 |
Recruitment Status :
Recruiting
First Posted : December 7, 2016
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Biological: Nivolumab Biological: Ipilimumab Drug: Cabazitaxel Drug: Prednisone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 497 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer |
Actual Study Start Date : | March 17, 2017 |
Estimated Primary Completion Date : | March 11, 2022 |
Estimated Study Completion Date : | June 26, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort A (Arm A) |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Cohort B (Arm B) |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Cohort C (Arm C) |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Cohort D (Arm D1) |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Cohort D (Arm D2) |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Cohort D (Arm D3) |
Biological: Ipilimumab
Specified dose on specified days
Other Names:
|
Experimental: Cohort D (Arm D4) |
Drug: Cabazitaxel
Specified dose on specified days Drug: Prednisone Specified dose on specified days |
- Objective Response Rate (ORR) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Approximately 24 weeks from treatment initiation ]
- Objective Response Rate (ORR) in Cohort D - Part 1 period [ Time Frame: Approximately 24 weeks from treatment initiation ]
- Radiographic Progression-Free Survival (rPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
- Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Approximately 12 months from treatment initiation ]
- Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D - Part 1 period [ Time Frame: Approximately 12 months from randomization ]
- Overall Survival (OS) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Up to 5 years from treatment initiation ]
- Overall Survival (OS) in Cohort D - Part 1 period [ Time Frame: Up to 5 years from randomization ]
- Incidence of Adverse Events (AEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of Adverse Events (AEs) leading to discontinuation [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of Immune-mediated Adverse Events (IMAEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of deaths [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Hematology [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Clinical Chemistry [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Coagulation [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Liver function [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Thyroid function [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Adrenal function [ Time Frame: From first dose up to and including 100 days post last dose ]
- Incidence of laboratory abnormalities: Renal function [ Time Frame: From first dose up to and including 100 days post last dose ]
- Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 12 months from treatment initiation ]
- Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L) [ Time Frame: Approximately 12 months from treatment initiation ]
- Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire [ Time Frame: Approximately 24 months from treatment initiation ]
- Prostate Specfic Antigen (PSA) Response Rate [ Time Frame: Up to 24 weeks from treatment initiation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985957
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain NCT# and Site #. |

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02985957 |
Other Study ID Numbers: |
CA209-650 2016-001928-54 ( EudraCT Number ) |
First Posted: | December 7, 2016 Key Record Dates |
Last Update Posted: | October 19, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Prednisone Nivolumab Ipilimumab |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antineoplastic Agents, Immunological |