A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
Megadott ok: Business objectives have changed
Key facts
- Where
- Atlanta, Baltimore, Beaumont, Bedford, Chicago, Cincinnati, Denton, Durham, Eugene, Flower Mound, Fort Worth, Hampton, Houston, Iowa City, Littleton, Los Angeles, Marietta, McKinney, Milwaukee, New Haven, New York, Newark, St Louis, Tucson és Tyler, Egyesült ÁllamokSee the 25 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- The Winship Cancer Institute of Emory UniversityAtlanta, Egyesült ÁllamokNo longer taking part
- The Johns Hopkins HospitalBaltimore, Egyesült ÁllamokNo longer taking part
- Texas Oncology-Beaumont Mamie McFaddin Ward Cancer CenterBeaumont, Egyesült ÁllamokNo longer taking part
- Texas OncologyBedford, Egyesült ÁllamokNo longer taking part
- The University of Chicago Medical Center - Duchossois Center for Advanced MedicineChicago, Egyesült ÁllamokNo longer taking part
- Oncology Hematology Care, Inc. - EastgateCincinnati, Egyesült ÁllamokNo longer taking part
- Texas Oncology - Denton NorthDenton, Egyesült ÁllamokNo longer taking part
- Duke Cancer InstituteDurham, Egyesült ÁllamokNo longer taking part
- Willamette Valley Cancer InstituteEugene, Egyesült ÁllamokNo longer taking part
- Texas OncologyFlower Mound, Egyesült ÁllamokNo longer taking part
- Texas Oncology - Fort Worth Cancer CenterFort Worth, Egyesült ÁllamokNo longer taking part
- HamptonHampton, Egyesült ÁllamokNo longer taking part
- The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, Egyesült ÁllamokNo longer taking part
- Rocky Mountain Cancer Centers-LittletonLittleton, Egyesült ÁllamokNo longer taking part
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- MariettaMarietta, Egyesült ÁllamokNo longer taking part
- Texas Oncology-McKinneyMcKinney, Egyesült ÁllamokNo longer taking part
- Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
- Yale School of MedicineNew Haven, Egyesült ÁllamokNo longer taking part
- New YorkNew York, Egyesült ÁllamokNo longer taking part
- Medical Oncology Hematology Consultants - NewarkNewark, Egyesült ÁllamokNo longer taking part
- Washington University School of Medicine in St. LouisSt Louis, Egyesült ÁllamokNo longer taking part
- Arizona Oncology - Tucson - Wilmot Road LocationTucson, Egyesült ÁllamokNo longer taking part
- Texas Oncology - TylerTyler, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05169684
- Record updated
- 2025. június 10.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Active, known or suspected autoimmune disease; Other protocol-defined inclusion/exclusion criteria apply; Untreated central nervous system (CNS) metastases; Leptomeningeal metastases.