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Trial record 3 of 19 for:    ipilimumab AND Bristol AND prostate

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 : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

November 22, 2016
December 7, 2016
June 19, 2018
March 17, 2017
December 16, 2018   (Final data collection date for primary outcome measure)
  • Objective Response Rate (ORR) [ Time Frame: Approximately 24 weeks from treatment initiation ]
    measured by response assessment
  • Radiographic Progression-Free Survival (rPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by radiographic/clinical progression
  • 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 ]
Complete list of historical versions of study NCT02985957 on ClinicalTrials.gov Archive Site
  • Radiographic/Clinical Progression-Free Survival (rcPFS) [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by radiographic/clinical progression
  • Overall Survival (OS) [ Time Frame: Up to 5 years from treatment initiation ]
    measured by time
  • Number of patients with adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients
  • Number of patients with serious adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients
  • Number of patients with adverse events leading to discontinuation [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients
  • Number of patients with immune-mediated adverse events [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients
  • Number of patients with deaths [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients
  • Number of patients with laboratory abnormalities [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by number of patients
  • 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
  • European Quality of Life- Five Dimensions (EQ-5D-3L) scores [ Time Frame: Approximately 12 months from treatment initiation ]
    measured by assessment
  • 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 ]
Not Provided
Not Provided
 
A Study to Evaluate Preliminary Safety and Efficacy of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • 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: 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

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cytotoxic Chemotherapy

    Subjects with progression after taxane-based chemotherapy

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

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
Same as current
March 24, 2022
December 16, 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   United States
 
 
NCT02985957
CA209-650
2016-001928-54 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2018

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