A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostatic Neoplasms, Castration-Resistant

In brief

The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.

Key facts

Study ID

NCT05169684

Run by

Bristol-Myers Squibb

People needed

10

Starts

2022-02-14

Expected to finish

2023-12-06

Last updated by the study team

2025-06-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologic confirmation of carcinoma of the prostate without small cell features
• 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)

You may not qualify if…

• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2
• Untreated central nervous system (CNS) metastases
• Leptomeningeal metastases
• Active, known or suspected autoimmune disease
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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