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

NCT05169684 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CA022-0092021-003990-74U1111-1268-2566
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 31

Brief Summary

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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

BMS-986218; BMS-936558; Docetaxel; Metastatic; MDX1106; Nivolumab; ONO-4538; TAXOTERE

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Prostate Specific Antigen Response Rate (PSA-RR)

  From first dose to 100 days follow up to last dose (Approximately 22 months)

• Objective Response Rate

  From first dose to 100 days follow up to last dose (Approximately 22 months)

• Time to Response

  From first dose to 100 days follow up to last dose (Approximately 22 months)

• Duration of Response

  From first dose to 100 days follow up to last dose (Approximately 22 months)

• Overall Survival

  From first dose to 100 days follow up to last dose (Approximately 22 months)

Study Arms (6)

Arm 1A: Docetaxel + BMS-986218

EXPERIMENTAL

Biological: BMS-986218; Drug: Docetaxel

Arm 1B: Docetaxel + BMS-986218 + Nivolumab

EXPERIMENTAL

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

Arm 2A: Docetaxel

EXPERIMENTAL

Drug: Docetaxel

Arm 2B: Docetaxel + BMS-986218

EXPERIMENTAL

Biological: BMS-986218; Drug: Docetaxel

Arm 2C: Docetaxel + BMS-986218 + Nivolumab

EXPERIMENTAL

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

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

EXPERIMENTAL

Biological: BMS-986218; Biological: Nivolumab

Interventions

BMS-986218 BIOLOGICAL

Specified dose on specified days

Arm 1A: Docetaxel + BMS-986218; Arm 1B: Docetaxel + BMS-986218 + Nivolumab; Arm 2B: Docetaxel + BMS-986218; Arm 2C: Docetaxel + BMS-986218 + Nivolumab; Arm 2D (Optional Crossover): BMS-986218 + Nivolumab

Docetaxel DRUG

Specified dose on specified days

Also known as: TAXOTERE

Arm 1A: Docetaxel + BMS-986218; Arm 1B: Docetaxel + BMS-986218 + Nivolumab; Arm 2A: Docetaxel; Arm 2B: Docetaxel + BMS-986218; Arm 2C: Docetaxel + BMS-986218 + Nivolumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, MDX1106, ONO-4538

Arm 1B: Docetaxel + BMS-986218 + Nivolumab; Arm 2C: Docetaxel + BMS-986218 + Nivolumab; Arm 2D (Optional Crossover): BMS-986218 + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (31)

Arizona Oncology - Tucson - Wilmot Road Location

Tucson, Arizona, 85711-2701, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027-5969, United States

Location

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, 80120-4413, United States

Location

Yale School Of Medicine

New Haven, Connecticut, 06510-3206, United States

Location

Medical Oncology Hematology Consultants - Newark

Newark, Delaware, 19713-2055, United States

Location

The Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322-1013, United States

Location

Local Institution - 0004

Marietta, Georgia, 30060, United States

Location

The University of Chicago Medical Center - Duchossois Center for Advanced Medicine

Chicago, Illinois, 60637-1426, United States

Location

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110-1010, United States

Location

Local Institution - 0006

New York, New York, 10032-3729, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Oncology Hematology Care, Inc. - Eastgate

Cincinnati, Ohio, 45245-1995, United States

Location

Willamette Valley Cancer Institute

Eugene, Oregon, 97477, United States

Location

Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Oncology

Bedford, Texas, 76022-6920, United States

Location

Texas Oncology - Denton North

Denton, Texas, 76201-4315, United States

Location

Texas Oncology

Flower Mound, Texas, 75028, United States

Location

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104-2150, United States

Location

The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center

Houston, Texas, 77030-4004, United States

Location

Texas Oncology - McKinney

McKinney, Texas, 75071-8106, United States

Location

Texas Oncology- Tyler

Tyler, Texas, 75702-8363, United States

Location

Local Institution - 0056

Hampton, Virginia, 23666-5963, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0003

Toulouse, 31100, France

Location

Local Institution - 0037

Milan, MI, 20162, Italy

Location

Local Institution - 0021

Rozzano, MI, 20089, Italy

Location

Local Institution - 0071

Meldola, 47014, Italy

Location

Local Institution - 0016

Modena, 41124, Italy

Location

Local Institution - 0029

Pozzuoli, 80078, Italy

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Neoplasm Metastasis

Interventions

Docetaxel; Nivolumab

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study was terminated early after the safety lead-in portion (Part 1).

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 27, 2021
• Study Start: February 14, 2022
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-05

Locations

IT (5); FR (1); US (25)