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Recruiting

A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer - CA022-009

Updated: 12 May, 2022   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 49

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm 1A: Docetaxel + BMS-986218
Drug: Docetaxel Biological: BMS-986218
Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab
Drug: Docetaxel Biological: BMS-986218 Biological: Nivolumab
Experimental: Arm 2A: Docetaxel
Drug: Docetaxel
Experimental: Arm 2B: Docetaxel + BMS-986218
Drug: Docetaxel Biological: BMS-986218
Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab
Biological: BMS-986218 Biological: Nivolumab Drug: Docetaxel
Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
Biological: Nivolumab Biological: BMS-986218

Key Eligibility Criteria

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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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com