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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT02985957

  • Recruitment Status

    Active, not recruiting

  • First Posted

    December 7, 2016

  • Last update posted

    October 18, 2021

Study Description

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:Prostate Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
    Drug: Cabazitaxel
    Drug: Prednisone
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 353 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 2017
  • Estimated Primary Completion Date: July 2022
  • Estimated Study Completion Date: October 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Cohort A (Arm A)
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Cohort B (Arm B)
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Cohort C (Arm C)
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Cohort D (Arm D1)
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Cohort D (Arm D2)
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Cohort D (Arm D3)
Biological: Ipilimumab
Specified dose on specified days
Experimental: Cohort D (Arm D4)
Drug: Cabazitaxel
Specified dose on specified days

Drug: Prednisone
Specified dose on specified days

Outcome Measures

  • 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. Overall Survival (OS) in Cohort D - Part 1 period [ Time Frame: Up to 5 years from randomization ]
  • 2. Incidence of Adverse Events (AEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
  • 3. Incidence of Serious Adverse Events (SAEs) [ Time Frame: From first dose up to and including 100 days post last dose ]
  • 4. Incidence of Adverse Events (AEs) leading to discontinuation [ Time Frame: From first dose up to and including 100 days post last dose ]
  • 5. Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Approximately 12 months from treatment initiation ]
  • 6. Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D - Part 1 period [ Time Frame: Approximately 12 months from randomization ]
  • 7. Overall Survival (OS) in Cohort B, C, and Cohort D - Part 2 period [ Time Frame: Up to 5 years from treatment initiation ]
  • 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

  • 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

Contacts

Locations

United States, Arizona
Arizona Oncology Associates, PC - HOPE
Tucson

United States, Georgia
Northwest Georgia Oncology Center, P.C.
Marietta

United States, Illinois
University of Chicago
Chicago

United States, Minnesota
Minnesota Oncology Hematology (Minneapolis) - USOR
Minneapolis

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, Nevada
Comprehensive Cancer Center Of Nevada
Las Vegas

United States, New York
New York Oncology Hematology Pc
Albany

United States, New York
Monter Cancer Center
Lake Success

United States, New York
Icahn School Of Medicine At Mount Sinai
New York

United States, Oregon
Northwest Cancer Specialists, P.C.
Tigard

United States, Pennsylvania
Lehigh Valley Health Network
Allentown

United States, Pennsylvania
University Of Pennsylvania
Philadelphia

United States, South Carolina
Medical University of South Carolina
Charleston

United States, Texas
Texas Oncology, PA - Central Austin Cancer Center
Austin

United States, Texas
MD Anderson Cancer Center
Houston

Australia, New South Wales
Local Institution
Gosford

Australia, New South Wales
Local Institution
Wahroonga

Australia, New South Wales
Local Institution
Westmead

Australia, Queensland
Local Institution
Southport

Australia, Queensland
Local Institution
Woolloongabba

Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale

Australia, Victoria
Local Institution
Clayton

Austria
Medizinische Universtaet Wien
Wien

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Centre Hospitalier De L'Universite De Montreal
Montreal

Denmark
Local Institution
Aalborg

Denmark
Local Institution
Aarhus N

Denmark
Local Institution
Kobenhavn O

Denmark
Local Institution
Odense

France
Local Institution
Clermont-ferrand

France
Centre Leon Berard
Lyon

France
Local Institution
Marseille Cedex 9

France
Local Institution
Villejuif

Germany
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig

Germany
Universitatsklinikum Carl Gustav Carus
Dresden

Germany
Georg August Universitaet Goettingen
Goettingen

Germany
Marien Hospital Herne
Herne

Germany
Universitaetsklinikum Jena
Jena

Germany
Universitaetsklinikum Muenster
Muenster

Germany
Klinikum Grosshadern
Munich

Germany
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg

Germany
Studienpraxis Urologie
Nuertingen

Germany
Urologische Praxis
Rostock

Germany
Uniklinik Tuebingen
Tuebingen

Germany
Urologische Gemeinschaftspraxis Dres Stammel U. Garcia
Wesel

Italy
Local Institution
Arezzo

Italy
Local Institution
Milano

Italy
Local Institution
Napoli

Italy
Local Institution
Parma

Italy
Local Institution
Terni

Poland
Oddzial Dzienny Chemioterapii
Koszalin

Poland
Local Institution
Krakow

Poland
Local Institution
Warszawa

Spain
Local Institution
Badajoz

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Malaga

Spain
Local Institution
Santiago Compostela

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT02985957 History of Changes
  • Other Study ID Numbers: CA209-650, 2016-001928-54
  • First Posted: December 7, 2016 Key Record Dates
  • Last Update Posted: October 18, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Prostatic Neoplasms