A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT05169684
Last Updated: 2025-06-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2022-02-14
2023-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1A: Docetaxel + BMS-986218
BMS-986218
Specified dose on specified days
Docetaxel
Specified dose on specified days
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
BMS-986218
Specified dose on specified days
Docetaxel
Specified dose on specified days
Nivolumab
Specified dose on specified days
Arm 2A: Docetaxel
Docetaxel
Specified dose on specified days
Arm 2B: Docetaxel + BMS-986218
BMS-986218
Specified dose on specified days
Docetaxel
Specified dose on specified days
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
BMS-986218
Specified dose on specified days
Docetaxel
Specified dose on specified days
Nivolumab
Specified dose on specified days
Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
BMS-986218
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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BMS-986218
Specified dose on specified days
Docetaxel
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
* Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
* Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)
Exclusion Criteria
* Untreated central nervous system (CNS) metastases
* Leptomeningeal metastases
* Active, known or suspected autoimmune disease
18 Years
MALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Arizona Oncology - Tucson - Wilmot Road Location
Tucson, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States
Yale School Of Medicine
New Haven, Connecticut, United States
Medical Oncology Hematology Consultants - Newark
Newark, Delaware, United States
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Local Institution - 0004
Marietta, Georgia, United States
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Local Institution - 0006
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Oncology Hematology Care, Inc. - Eastgate
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology
Bedford, Texas, United States
Texas Oncology - Denton North
Denton, Texas, United States
Texas Oncology
Flower Mound, Texas, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
Houston, Texas, United States
Texas Oncology - McKinney
McKinney, Texas, United States
Texas Oncology- Tyler
Tyler, Texas, United States
Local Institution - 0056
Hampton, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution - 0003
Toulouse, , France
Local Institution - 0037
Milan, MI, Italy
Local Institution - 0021
Rozzano, MI, Italy
Local Institution - 0071
Meldola, , Italy
Local Institution - 0016
Modena, , Italy
Local Institution - 0029
Pozzuoli, , Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-003990-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1268-2566
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA022-009
Identifier Type: -
Identifier Source: org_study_id
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