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

  • Clinicaltrials.gov identifier

    NCT05169684

  • Recruitment Status

    Recruiting

  • First Posted

    December 27, 2021

  • Last update posted

    May 13, 2022

Study Description

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.

  • Condition or Disease:Prostatic Neoplasms, Castration-Resistant
  • Intervention/Treatment: Biological: BMS-986218
    Drug: Docetaxel
    Biological: Nivolumab
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 204 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
  • Actual Study Start Date: February 2022
  • Estimated Primary Completion Date: February 2026
  • Estimated Study Completion Date: February 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Arm 1A: Docetaxel + BMS-986218
Biological: BMS-986218
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days
Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab
Biological: BMS-986218
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Arm 2B: Docetaxel + BMS-986218
Biological: BMS-986218
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days
Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab
Biological: BMS-986218
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
Biological: BMS-986218
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Arm 2A: Docetaxel
Drug: Docetaxel
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 1
  • 2. Number of deaths [ Time Frame: Up to 2 years ]
    Part 1
  • 3. Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
  • Secondary Outcome Measures: 1. Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
  • 2. Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ]
    Part 2
  • 3. Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ]
    Part 2
  • 4. Prostate-specific antigen response rate (PSA-RR) [ Time Frame: Up to 4 years ]
    Part 2
  • 5. Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 [ Time Frame: Up to 4 years ]
    Part 2
  • 6. Overall survival (OS) [ Time Frame: Up to 4 years ]
    Part 2
  • 7. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 2
  • 8. Number of deaths [ Time Frame: Up to 2 years ]
    Part 2

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arizona
Arizona Oncology - Tucson - Wilmot Road Location
Tucson

United States, California
Local Institution
Los Angeles

United States, Colorado
Rocky Mountain Cancer Centers (Littleton) - USOR
Littleton

United States, Connecticut
Local Institution
New Haven

United States, Delaware
Medical oncology Hematology Consultants PA, Helen F Graham Cancer Center
Newark

United States, Florida
Florida Urology Partners, LLP - Tampa
Tampa

United States, Georgia
Local Institution
Atlanta

United States, Georgia
Northwest Georgia Oncology Centers PC
Marietta

United States, Illinois
Local Institution
Chicago

United States, Maryland
Local Institution
Baltimore

United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia

United States, Missouri
Local Institution
Saint Louis

United States, New York
Columbia University Medical Center Herbert Irving Pavilion
New York

United States, North Carolina
Local Institution
Cary

United States, Ohio
Oncology Hematology Care Incorporated
Cincinnati

United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene

United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia

United States, Texas
Texas Oncology-Beaumont
Beaumont

United States, Texas
Texas Oncology
Bedford

United States, Texas
Texas Oncology - Denton North
Denton

United States, Texas
Texas Oncology
Flower Mound

United States, Texas
Texas Oncology - Fort Worth Cancer Center
Fort Worth

United States, Texas
Local Institution
Houston

United States, Texas
Local Institution
McKinney

United States, Texas
Texas Oncology-Tyler
Tyler

United States, Virginia
Local Institution
Hampton

United States, Wisconsin
Local Institution
Milwaukee

Argentina, Buenos Aires
Local Institution
Ciudad de Buenos Aires

Argentina, Buenos Aires
Local Institution
Mar Del Plata

Argentina, Buenos Aires
Local Institution
Pergamino

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution - 0018
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Tucuman

Australia, New South Wales
Local Institution
Darlinghurst

Australia, South Australia
Local Institution
Elizabeth Vale

Australia, Victoria
Local Institution
Heidleberg

Canada, Ontario
Local Institution
Hamilton

Canada, Ontario
Local Institution
Toronto

Canada
Local Institution
Quebec

France, Paca
Local Institution
Nice

France
Local Institution
Besançon

France
Local Institution
Bordeaux

France
Local Institution
Brest

France
Local Institution
Clermont-Ferrand

France
Local Institution
Lyon

France
Local Institution
Marseille

France
Local Institution
Saint-Quentin

France
Local Institution
Toulouse

France
Local Institution
Villejuif Cedex

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Marousi

Greece
Local Institution
Pylaia-Chortiatis

Greece
Local Institution
Thessaloniki

Greece
Local Institution
Thessaloniki

Italy
Local Institution
Meldola

Italy
Local Institution
Milano

Italy
Local Institution
Modena

Italy
Local Institution
Pozzuoli

Italy
Local Institution
Roma

Italy
Local Institution
Rozzano

Netherlands
Local Institution
Dordrecht

Netherlands
Local Institution
Rotterdam

Netherlands
Local Institution
Rotterdam

Spain
Local Institution
Badajoz

Spain
Local Institution
Madrid

Spain
Local Institution
Santander

United Kingdom
Local Institution
Blackburn

United Kingdom
Local Institution
Brighton

United Kingdom
Local Institution
Bristol

United Kingdom
Local Institution
Guildford

United Kingdom
Local Institution
Huddersfield

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Preston

United Kingdom
Local Institution
Torquay

United Kingdom
Local Institution
Truro

United Kingdom
Local Institution
Wolverhampton

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05169684 History of Changes
  • Other Study ID Numbers: CA022-009, 2021-003990-74, U1111-1268-2566
  • First Posted: December 27, 2021 Key Record Dates
  • Last Update Posted: May 13, 2022
  • Last Verified: May 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: BMS-986218
    BMS-936558
    Docetaxel
    Metastatic
    MDX1106
    Nivolumab
    ONO-4538
    TAXOTERE
  • Additional relevant MeSH terms: Prostatic Neoplasms
    Prostatic Neoplasms, Castration-Resistant
    Genital Neoplasms, Male
    Urogenital Neoplasms
    Neoplasms by Site
    Neoplasms
    Prostatic Diseases