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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
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE March 17, 2017
Estimated Primary Completion Date March 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Objective Response Rate (ORR) [ Time Frame: Approximately 24 weeks from treatment initiation ]
  • Radiographic Progression-Free Survival (rPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Radiographic/Clinical Progression-Free Survival (rcPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
  • Overall Survival (OS) [ Time Frame: Up to 5 years from treatment initiation ]
  • Number of subjects with adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
  • Number of subjects with serious adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
  • Number of subjects with adverse events leading to discontinuation [ Time Frame: Approximately 12 months from treatment initiation ]
  • Number of subjects with immune-mediated adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
  • Number of subjects with deaths [ Time Frame: Approximately 12 months from treatment initiation ]
  • Number of subjects with laboratory abnormalities [ Time Frame: Approximately 12 months from treatment initiation ]
  • Number of subjects with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 12 months from treatment initiation ]
  • European Quality of Life- Five Dimensions (EQ-5D-3L) scores [ Time Frame: Approximately 12 months from treatment initiation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • BMS-734016
    • Yervoy
  • Drug: Cabazitaxel
    Specified dose on specified days
  • Drug: Prednisone
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Cohort A (Arm A)
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cohort B (Arm B)
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cohort C (Arm C)
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cohort D (Arm D1)
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cohort D (Arm D2)
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cohort D (Arm D3)
    Intervention: Biological: Ipilimumab
  • Experimental: Cohort D (Arm D4)
    Interventions:
    • Drug: Cabazitaxel
    • Drug: Prednisone
Publications * Sharma P, Pachynski RK, Narayan V, Fléchon 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2020)
497
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
90
Estimated Study Completion Date  ICMJE June 26, 2024
Estimated Primary Completion Date March 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Denmark,   France,   Germany,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02985957
Other Study ID Numbers  ICMJE CA209-650
2016-001928-54 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP