Overview

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

Status:
Not yet recruiting
Trial end date:
2025-12-21
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to assess the safety, 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Docetaxel
Nivolumab
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

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