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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985957
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior docetaxel-containing regimen.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Nivolumab Biological: Ipilimumab Drug: Cabazitaxel Drug: Prednisone Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A (Arm A) Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Cohort B (Arm B) Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Cohort C (Arm C) Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Cohort D (Arm D1) Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Cohort D (Arm D2) Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Cohort D (Arm D3) Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Cohort D (Arm D4) Drug: Cabazitaxel
Specified dose on specified days

Drug: Prednisone
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Approximately 24 weeks from treatment initiation ]
  2. Objective Response Rate (ORR) in Cohort D - Part 1 period [ Time Frame: Approximately 24 weeks from treatment initiation ]
  3. Radiographic Progression-Free Survival (rPFS) [ Time Frame: Approximately 12 months from treatment initiation ]

Secondary Outcome Measures :
  1. Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Approximately 12 months from treatment initiation ]
  2. Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D - Part 1 period [ Time Frame: Approximately 12 months from randomization ]
  3. Overall Survival (OS) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Up to 5 years from treatment initiation ]
  4. Overall Survival (OS) in Cohort D - Part 1 period [ Time Frame: Up to 5 years from randomization ]
  5. Incidence of Adverse Events (AEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
  6. Incidence of Serious Adverse Events (SAEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
  7. Incidence of Adverse Events (AEs) leading to discontinuation [ Time Frame: From first dose up to and including 100 days post last dose ]
  8. Incidence of Immune-mediated Adverse Events (IMAEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
  9. Incidence of deaths [ Time Frame: From first dose up to and including 100 days post last dose ]
  10. Incidence of laboratory abnormalities: Hematology [ Time Frame: From first dose up to and including 100 days post last dose ]
  11. Incidence of laboratory abnormalities: Clinical Chemistry [ Time Frame: From first dose up to and including 100 days post last dose ]
  12. Incidence of laboratory abnormalities: Coagulation [ Time Frame: From first dose up to and including 100 days post last dose ]
  13. Incidence of laboratory abnormalities: Liver function [ Time Frame: From first dose up to and including 100 days post last dose ]
  14. Incidence of laboratory abnormalities: Thyroid function [ Time Frame: From first dose up to and including 100 days post last dose ]
  15. Incidence of laboratory abnormalities: Adrenal function [ Time Frame: From first dose up to and including 100 days post last dose ]
  16. Incidence of laboratory abnormalities: Renal function [ Time Frame: From first dose up to and including 100 days post last dose ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. Prostate Specfic Antigen (PSA) Response Rate [ Time Frame: Up to 24 weeks from treatment initiation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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