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

A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Prostatic Neoplasms, Castration-Resistant
• Intervention / Treatment: Biological: Nivolumab; Drug: Docetaxel; Biological: BMS-986218

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31100
    • Local Institution - 0003
• Italy
  • Meldola, Italy, 47014
    • Local Institution - 0071
  • Modena, Italy, 41124
    • Local Institution - 0016
  • Pozzuoli, Italy, 80078
    • Local Institution - 0029
  • MI
    • Milano, MI, Italy, 20162
      • Local Institution - 0037
    • Rozzano, MI, Italy, 20089
      • Local Institution - 0021
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711-2701
      • Arizona Oncology - Tucson - Wilmot Road Location
  • California
    • Los Angeles, California, United States, 90027-5969
      • Kaiser Permanente Los Angeles Medical Center
  • Colorado
    • Littleton, Colorado, United States, 80120-4413
      • Rocky Mountain Cancer Centers - Littleton
  • Connecticut
    • New Haven, Connecticut, United States, 06510-3206
      • Yale School of Medicine
  • Delaware
    • Newark, Delaware, United States, 19713-2055
      • Medical Oncology Hematology Consultants - Newark
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • The Winship Cancer Institute of Emory University
    • Marietta, Georgia, United States, 30060
      • Local Institution - 0004
  • Illinois
    • Chicago, Illinois, United States, 60637-1426
      • The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110-1010
      • Washington University School of Medicine in St. Louis
  • New York
    • New York, New York, United States, 10032-3729
      • Local Institution - 0006
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45245-1995
      • Oncology Hematology Care, Inc. - Eastgate
  • Oregon
    • Eugene, Oregon, United States, 97477
      • Willamette Valley Cancer Institute
  • Texas
    • Beaumont, Texas, United States, 77702
      • Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center
    • Bedford, Texas, United States, 76022-6920
      • Texas Oncology
    • Denton, Texas, United States, 76201-4315
      • Texas Oncology - Denton North
    • Flower Mound, Texas, United States, 75028
      • Texas Oncology
    • Fort Worth, Texas, United States, 76104-2150
      • Texas Oncology - Fort Worth Cancer Center
    • Houston, Texas, United States, 77030-4004
      • The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
    • McKinney, Texas, United States, 75071-8106
      • Texas Oncology - McKinney
    • Tyler, Texas, United States, 75702-8363
      • Texas Oncology- Tyler
  • Virginia
    • Hampton, Virginia, United States, 23666-5963
      • Local Institution - 0056
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1A: Docetaxel + BMS-986218	Drug: Docetaxel; Specified dose on specified days; Other Names: TAXOTERE; Biological: BMS-986218; Specified dose on specified days
Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558, MDX1106, ONO-4538; Drug: Docetaxel; Specified dose on specified days; Other Names: TAXOTERE; Biological: BMS-986218; Specified dose on specified days
Experimental: Arm 2A: Docetaxel	Drug: Docetaxel; Specified dose on specified days; Other Names: TAXOTERE
Experimental: Arm 2B: Docetaxel + BMS-986218	Drug: Docetaxel; Specified dose on specified days; Other Names: TAXOTERE; Biological: BMS-986218; Specified dose on specified days
Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558, MDX1106, ONO-4538; Drug: Docetaxel; Specified dose on specified days; Other Names: TAXOTERE; Biological: BMS-986218; Specified dose on specified days
Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558, MDX1106, ONO-4538; Biological: BMS-986218; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Related Adverse Events	Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).	From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants With Treatment Related Serious Adverse Events	Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).	From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants With Dose Limiting Toxicities	DLTs will be defined as: Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment. Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for > 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.	From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants With AEs Leading to Discontinuation	Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).	From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants Who Died	Number of participant deaths	From first dose to 100 days follow up to last dose (Approximately 22 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate Specific Antigen Response Rate (PSA-RR)	PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.	From first dose to 100 days follow up to last dose (Approximately 22 months)
Objective Response Rate	Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.	From first dose to 100 days follow up to last dose (Approximately 22 months)
Time to Response	Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.	From first dose to 100 days follow up to last dose (Approximately 22 months)
Duration of Response	Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.	From first dose to 100 days follow up to last dose (Approximately 22 months)
Overall Survival	OS for all randomized participants is the time between randomization date and the date of death from any cause.	From first dose to 100 days follow up to last dose (Approximately 22 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Docetaxel; Nivolumab; Metastatic; BMS-936558; ONO-4538; TAXOTERE; BMS-986218; MDX1106
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Nivolumab
• Other Study ID Numbers: CA022-009; 2021-003990-74 (EudraCT Number); U1111-1268-2566 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No