A Phase 2 Trial of BMS-986218 or BMS-986218/Nivolumab in Combination with Docetaxel in Metastatic Castration-resistant Prostate Cancer

Phase 1

• Conditions: Metastatic Castration-resistant Prostate Cancer; MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003990-74-GR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 204

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).

Other protocol-defined inclusion criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 163
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

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 exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified