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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05169684
Phase
PHASE2
Status
Terminated

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986218 — BIOLOGICAL
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Feb 14, 2022
Status verified
May 2025
Primary completion
Dec 6, 2023
Completion
Dec 6, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants With Treatment Related Adverse Events [ Time Frame: From first dose to 100 days follow up to last dose (Approximately 22 months) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Arizona Oncology - Tucson - Wilmot Road LocationTucsonArizona85711-2701-
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-5969-
Rocky Mountain Cancer Centers - LittletonLittletonColorado80120-4413-
Yale School Of MedicineNew HavenConnecticut06510-3206-
Medical Oncology Hematology Consultants - NewarkNewarkDelaware19713-2055-
The Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-1013-
Local Institution - 0004MariettaGeorgia30060-
The University of Chicago Medical Center - Duchossois Center for Advanced MedicineChicagoIllinois60637-1426-
University Of Iowa Hospitals And ClinicsIowa CityIowa52242-
The Johns Hopkins HospitalBaltimoreMaryland21287-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-1010-
Local Institution - 0006New YorkNew York10032-3729-
Duke Cancer InstituteDurhamNorth Carolina27710-
Oncology Hematology Care, Inc. - EastgateCincinnatiOhio45245-1995-
Willamette Valley Cancer InstituteEugeneOregon97477-
Texas Oncology-Beaumont Mamie McFaddin Ward Cancer CenterBeaumontTexas77702-
Texas OncologyBedfordTexas76022-6920-
Texas Oncology - Denton NorthDentonTexas76201-4315-
Texas OncologyFlower MoundTexas75028-
Texas Oncology - Fort Worth Cancer CenterFort WorthTexas76104-2150-
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer CenterHoustonTexas77030-4004-
Texas Oncology - McKinneyMcKinneyTexas75071-8106-
Texas Oncology- TylerTylerTexas75702-8363-
Local Institution - 0056HamptonVirginia23666-5963-
Medical College of WisconsinMilwaukeeWisconsin53226-

Related coverage on Hipa.ai

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By research site
Arizona Oncology - Tucson - Wilmot Road Location· Tucson, AZKaiser Permanente Los Angeles Medical Center· Los Angeles, CARocky Mountain Cancer Centers - Littleton· Littleton, COYale School Of Medicine· New Haven, CTMedical Oncology Hematology Consultants - Newark· Newark, DEThe Winship Cancer Institute of Emory University· Atlanta, GA

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