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

  • STATUS
    Recruiting
  • End date
    Feb 13, 2026
  • participants needed
    204
  • sponsor
    Bristol-Myers Squibb
Updated on 4 October 2022

Summary

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.

Details
Condition Prostatic Neoplasms, Castration-Resistant
Treatment docetaxel, Nivolumab, BMS-986218
Clinical Study IdentifierNCT05169684
SponsorBristol-Myers Squibb
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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