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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Histologic confirmation of carcinoma of the prostate without small cell features
  2. Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
  3. 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)
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  5. 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
  6. Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)

EXCLUSION CRITERIA

Exclusion Criteria:


  1. 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
  2. Untreated central nervous system (CNS) metastases
  3. Leptomeningeal metastases
  4. Active, known or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply


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Study Locations

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How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study Details


Contition
Prostatic Neoplasms, Castration-Resistant
Age (in years)
18+
Phase
Phase 2
Participants Needed
204
Est. Completion Date
Feb 13, 2026
Treatment Type
Interventional

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT05169684
Study Number
CA022009

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