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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Prostatic Neoplasms, Castration-Resistant

Treatments: Biological: Nivolumab; Drug: Docetaxel; Biological: BMS-986218

Study type: Interventional

Funder types: Industry

Identifiers

NCT05169684

U1111-1268-2566 (Registry Identifier)

CA022-009

2021-003990-74 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 6 patient groups

Arm 1A: Docetaxel + BMS-986218

Experimental group

Treatment:

Biological: BMS-986218

Drug: Docetaxel

Arm 1B: Docetaxel + BMS-986218 + Nivolumab

Experimental group

Treatment:

Biological: BMS-986218

Drug: Docetaxel

Biological: Nivolumab

Arm 2A: Docetaxel

Experimental group

Treatment:

Drug: Docetaxel

Arm 2B: Docetaxel + BMS-986218

Experimental group

Treatment:

Biological: BMS-986218

Drug: Docetaxel

Arm 2C: Docetaxel + BMS-986218 + Nivolumab

Experimental group

Treatment:

Biological: BMS-986218

Drug: Docetaxel

Biological: Nivolumab

Arm 2D (Optional Crossover): BMS-986218 + Nivolumab

Experimental group

Treatment:

Biological: BMS-986218

Biological: Nivolumab