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A Study to Evaluate Preliminary Safety and Efficacy of Nivolumab Plus Ipilimumab 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 : April 30, 2018
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 treatment of metastatic castration-resistant prostate cancer

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : December 16, 2018
Estimated Study Completion Date : March 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Second Generation Hormone Therapies

Asymptomatic or minimally symptomatic subjects who have progressed after second generation hormone therapies and have not been treated with chemotherapy

Subjects will be treated with nivolumab in combination with ipilimumab followed by nivolumab monotherapy

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: Cytotoxic Chemotherapy

Subjects with progression after taxane-based chemotherapy

Subjects will be treated with nivolumab in combination with ipilimumab followed by nivolumab monotherapy

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 24 weeks from treatment initiation ]
    measured by response assessment

  2. Radiographic Progression-Free Survival (rPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by radiographic/clinical progression


Secondary Outcome Measures :
  1. Radiographic/Clinical Progression-Free Survival (rcPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by radiographic/clinical progression

  2. Overall Survival (OS) [ Time Frame: Up to 5 years from treatment initiation ]
    measured by time

  3. Number of patients with adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  4. Number of patients with serious adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  5. Number of patients with adverse events leading to discontinuation [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  6. Number of patients with immune-mediated adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  7. Number of patients with deaths [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  8. Number of patients with laboratory abnormalities [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  9. Number of patients with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients

  10. European Quality of Life- Five Dimensions (EQ-5D-3L) scores [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by assessment



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:

  • Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria)
  • 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)
  • Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment
  • Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before

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)

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
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
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Akash Patnaik, Site 0011         
United States, Missouri
Washington University School Of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Icahn School Of Medicine At Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Matthew Galsky, Site 0001         
Local Institution Withdrawn
New York, New York, United States, 10065
United States, Pennsylvania
University Of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vivek Narayan, Site 0010         
United States, Texas
MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
France
Local Institution Recruiting
Clermont-ferrand, France, 63000
Contact: Site 0009         
Local Institution Recruiting
Lyon, France, 69008
Contact: Site 0005         
Local Institution Recruiting
Marseille Cedex 9, France, 13273
Contact: Site 0004         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0003         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02985957     History of Changes
Other Study ID Numbers: CA209-650
2016-001928-54 ( EudraCT Number )
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs