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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 : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 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 : June 28, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 24 weeks from treatment initiation ]
  2. Radiographic Progression-Free Survival (rPFS) [ Time Frame: Approximately 12 months from treatment initiation ]

Secondary Outcome Measures :
  1. Radiographic/Clinical Progression-Free Survival (rcPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
  2. Overall Survival (OS) [ Time Frame: Up to 5 years from treatment initiation ]
  3. Number of participants with adverse events [ Time Frame: From first dose up to and including 100 days post last dose ]
  4. Number of participants with serious adverse events [ Time Frame: From first dose up to and including 100 days post last dose ]
  5. Number of participants with adverse events leading to discontinuation [ Time Frame: From first dose up to and including 100 days post last dose ]
  6. Number of participants with immune-mediated adverse events [ Time Frame: From first dose up to and including 100 days post last dose ]
  7. Number of participants with deaths [ Time Frame: From first dose up to and including 100 days post last dose ]
  8. Number of participants with laboratory abnormalities [ Time Frame: From first dose up to and including 100 days post last dose ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. Prostate Specfic Antigen (PSA) Response Rate [ Time Frame: Up to 24 weeks from treatment initiation ]


Information from the National Library of Medicine

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.


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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:

  • Evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria) on previous bone, CT and/or MRI scan.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • 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)
  • Participants with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment

Exclusion Criteria:

  • Cancer that has spread to the liver or brain
  • Active, known, or suspected autoimmune disease or infection
  • Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
  • Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment.

Other protocol defined inclusion/exclusion criteria could apply


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
Hide Hide 73 study locations
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United States, Arizona
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85711
Contact: Christopher Di Simone, Site 0074         
United States, California
Local Institution Not yet recruiting
Fresno, California, United States, 93703
Contact: Site 0064         
Local Institution Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Site 0050         
United States, Connecticut
Local Institution Not yet recruiting
West Haven, Connecticut, United States, 06516
Contact: Site 0057         
United States, Georgia
Northwest Georgia Oncology Center, P.C. Recruiting
Marietta, Georgia, United States, 30060
Contact: Steven McCune, Site 0046    770-281-5124      
Local Institution Not yet recruiting
Newnan, Georgia, United States, 30265
Contact: Site 0068         
United States, Illinois
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
Local Institution Not yet recruiting
Zion, Illinois, United States, 60099
Contact: Site 0073         
United States, Kentucky
Local Institution Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Site 0049         
United States, Minnesota
Minnesota Oncology Hematology (Minneapolis) - USOR Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Samith Kochuparambil, Site 0076         
United States, Missouri
Washington University School Of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Center Of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Oscar Goodman, Site 0075         
United States, New York
New York Oncology Hematology Pc Recruiting
Albany, New York, United States, 12208
Contact: David Shaffer, Site 0078         
Local Institution Not yet recruiting
Lake Success, New York, United States, 11042
Contact: Site 0065         
Icahn School Of Medicine At Mount Sinai Active, not recruiting
New York, New York, United States, 10029
Local Institution Withdrawn
New York, New York, United States, 10065
United States, Oregon
Northwest Cancer Specialists, P.C. Recruiting
Tigard, Oregon, United States, 97223
Contact: Ian Schnadig, Site 0077         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Maged Khalil, Site 0047    610-402-1184      
University Of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Site 0045         
United States, South Carolina
Local Institution Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Site 0067         
United States, Texas
Local Institution Not yet recruiting
Austin, Texas, United States, 78731
Contact: Site 0079         
MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Australia, New South Wales
Local Institution Recruiting
Gosford, New South Wales, Australia, 2250
Contact: Site 0027         
Local Institution Not yet recruiting
Wahroonga, New South Wales, Australia, 2076
Contact: Site 0059         
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0029         
Australia, Queensland
Local Institution Recruiting
Southport, Queensland, Australia, 4215
Contact: Site 0028         
Local Institution Recruiting
Woolloongabba, Queensland, Australia, 4012
Contact: Site 0043         
Australia, South Australia
Local Institution Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Site 0030         
Australia, Victoria
Local Institution Recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0031         
Austria
Medizinische Universtaet Wien Recruiting
Wien, Austria, 1090
Contact: Michael Krainer, Site 0048    +4314040075720 0 000 0000 000      
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: Site 0069         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Site 0070         
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Site 0044         
Denmark
Local Institution Recruiting
Aalborg, Denmark, 9000
Contact: Site 0062         
Local Institution Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Site 0063         
Local Institution Recruiting
Kobenhavn O, Denmark, 2100
Contact: Site 0061         
Local Institution Recruiting
Odense, Denmark, 5000
Contact: Site 0060         
France
Local Institution Not yet recruiting
Bordeaux, France, 33076
Contact: Site 0014         
Local Institution Active, not recruiting
Clermont-ferrand, France, 63000
Centre Leon Berard Active, not recruiting
Lyon, France, 69008
Local Institution Active, not recruiting
Marseille Cedex 9, France, 13273
Local Institution Not yet recruiting
Nice, France, 06189
Contact: Site 0012         
Local Institution Not yet recruiting
Quimper Cedex, France, 29107
Contact: Site 0015         
Local Institution Not yet recruiting
Strasbourg Cedex, France, 67091
Contact: Site 0013         
Local Institution Active, not recruiting
Villejuif, France, 94805
Germany
Local Institution Not yet recruiting
Braunschweig, Germany, 38114
Contact: Site 0041         
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Carsten Gruellich, Site 0032    +493514582157      
Universitaetsmedizin Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Arne Strauss, Site 0038         
Marien Hospital Herne Recruiting
Herne, Germany, 44625
Contact: Florian Roghmann, Site 0019    +4923234995252      
Universitaetsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Marc-Oliver Grimm, Site 0017    +4936419329945 0000 000 0000      
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48149
Contact: Martin Boegemann, Site 0018    +492518349949 000 0000000      
Local Institution Not yet recruiting
Munich, Germany, 81377
Contact: Site 0034         
Klinikum Nuernberg Nord, Urologische Klinik Recruiting
Nuernberg, Germany, 90419
Contact: Marinela Augustin, Site 0037    +499113983085      
Studienpraxis Urologie Recruiting
Nuertingen, Germany, 72622
Contact: Tilman Todenhofer, Site 0042    +4915201622246      
Urologische Praxis Recruiting
Rostock, Germany, 18107
Contact: Andreas Huebner, Site 0036    +493817601704 000 000 00 00      
Uniklinik Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Jens Bedke, Site 0033         
Urologische Gemeinschaftspraxis Dres Stammel U. Garcia Recruiting
Wesel, Germany, 46483
Contact: Miguel Garcia Schuermann, Site 0035    +492814755590      
Italy
Local Institution Recruiting
Arezzo, Italy, 52100
Contact: Site 0071         
Local Institution Recruiting
Milano, Italy, 20133
Contact: Site 0052         
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 0053         
Local Institution Not yet recruiting
Parma, Italy, 43100
Contact: Site 0072         
Local Institution Recruiting
Terni, Italy, 05100
Contact: Site 0051         
Poland
Oddzial Dzienny Chemioterapii Recruiting
Koszalin, Poland, 75-581
Contact: Mariusz Kwiatkowski, Site 0066         
Local Institution Recruiting
Krakow, Poland, 31-501
Contact: Site 0055         
Local Institution Recruiting
Warszawa, Poland, 02-781
Contact: Site 0054         
Spain
Local Institution Recruiting
Badajoz, Spain, 06080
Contact: Site 0026         
Local Institution Recruiting
Barcelona, Spain, 08003
Contact: Site 0025         
Local Institution Recruiting
Madrid, Spain, 28007
Contact: Site 0020         
Local Institution Recruiting
Madrid, Spain, 28027
Contact: Site 0022         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0021         
Local Institution Not yet recruiting
Malaga, Spain, 29010
Contact: Site 0024         
Local Institution Recruiting
Santiago Compostela, Spain, 15706
Contact: Site 0023         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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: January 13, 2020
Last Verified: January 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
Genital Diseases, Male
Prostatic Diseases
Prednisone
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal