A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT05169684
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 1A: Docetaxel + BMS-986218 BMS-986218 - Arm 1B: Docetaxel + BMS-986218 + Nivolumab BMS-986218 - Arm 1B: Docetaxel + BMS-986218 + Nivolumab Nivolumab - Arm 2B: Docetaxel + BMS-986218 BMS-986218 - Arm 2B: Docetaxel + BMS-986218 Docetaxel - Arm 2C: Docetaxel + BMS-986218 + Nivolumab BMS-986218 - Arm 2C: Docetaxel + BMS-986218 + Nivolumab Docetaxel - Arm 2C: Docetaxel + BMS-986218 + Nivolumab Nivolumab - Arm 2D (Optional Crossover): BMS-986218 + Nivolumab BMS-986218 - Arm 2D (Optional Crossover): BMS-986218 + Nivolumab Nivolumab - Arm 1A: Docetaxel + BMS-986218 Docetaxel - Arm 1B: Docetaxel + BMS-986218 + Nivolumab Docetaxel - Arm 2A: Docetaxel Docetaxel -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 2 years Part 1
Number of deaths Up to 2 years Part 1
Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3) Up to 4 years Part 2
- Secondary Outcome Measures
Name Time Method Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR Up to 4 years Part 2
Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) Up to 4 years Part 2
Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR Up to 4 years Part 2
Prostate-specific antigen response rate (PSA-RR) Up to 4 years Part 2
Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 Up to 4 years Part 2
Overall survival (OS) Up to 4 years Part 2
Number of participants with adverse events (AEs) Up to 2 years Part 2
Number of deaths Up to 2 years Part 2
Trial Locations
- Locations (69)
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Local Institution - 0028
🇨🇦Toronto, Ontario, Canada
The Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Texas Oncology- Tyler
🇺🇸Tyler, Texas, United States
Local Institution - 0046
🇦🇷Buenos Aires, Argentina
Rocky Mountain Cancer Centers - Littleton
🇺🇸Littleton, Colorado, United States
Willamette Valley Cancer Institute
🇺🇸Eugene, Oregon, United States
Texas Oncology - McKinney
🇺🇸McKinney, Texas, United States
Virginia Oncology Associates - Hampton
🇺🇸Hampton, Virginia, United States
Local Institution - 0007
🇬🇷Athina, I, Greece
Local Institution - 0014
🇫🇷Villejuif Cedex, France
Yale School Of Medicine
🇺🇸New Haven, Connecticut, United States
Texas Oncology - Denton North
🇺🇸Denton, Texas, United States
Local Institution - 0055
🇦🇷Buenos Aires, C, Argentina
Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Local Institution - 0003
🇫🇷Toulouse, France
Local Institution - 0041
🇦🇷MarDel Lata, Argentina
Columbia University Medical Center - Herbert Irving Pavilion Location
🇺🇸New York, New York, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Local Institution - 0081
🇬🇷Thessaloniki, B, Greece
Local Institution - 0051
🇬🇧Torquay, TOB, United Kingdom
Local Institution - 0053
🇬🇧Guildford, SRY, United Kingdom
Local Institution - 0008
🇫🇷Lyon, France
Arizona Oncology - Tucson - Wilmot Road Location
🇺🇸Tucson, Arizona, United States
Northwest Georgia Oncology Centers, P.C.
🇺🇸Marietta, Georgia, United States
University Of Iowa Hospitals And Clinics
🇺🇸Iowa City, Iowa, United States
Medical Oncology Hematology Consultants - Newark
🇺🇸Newark, Delaware, United States
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
🇺🇸Chicago, Illinois, United States
Oncology Hematology Care, Inc. - Eastgate
🇺🇸Cincinnati, Ohio, United States
Texas Oncology - Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
🇺🇸Houston, Texas, United States
Local Institution - 0070
🇦🇷Pergamino, B, Argentina
Local Institution - 0039
🇦🇷Buenos Aires, Argentina
Local Institution - 0025
🇦🇷San Miguel De Tocuman, T, Argentina
Local Institution - 0067
🇨🇦Hamilton, Ontario, Canada
Local Institution - 0083
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0080
🇫🇷Bordeaux, France
Local Institution - 0011
🇫🇷Besancon, France
Local Institution - 0062
🇦🇷San Juan, Argentina
Local Institution - 0086
🇫🇷Angers, France
Local Institution - 0023
🇫🇷Clermont-Ferrand CEDEX 01, France
Local Institution - 0015
🇨🇦Québec, Quebec, Canada
Local Institution - 0031
🇫🇷Brest, France
Local Institution - 0012
🇫🇷Nice CEDEX 2, France
Local Institution - 0076
🇫🇷Marseille, France
Local Institution - 0049
🇫🇷St Quentin, France
Local Institution - 0010
🇬🇷Athens, I, Greece
Local Institution - 0027
🇬🇷Athina, I, Greece
Local Institution - 0054
🇬🇷Marousi, I, Greece
Local Institution - 0032
🇬🇷Peiraias, I, Greece
Local Institution - 0077
🇬🇷Athens, Greece
Local Institution - 0037
🇮🇹Milano, MI, Italy
Local Institution - 0069
🇬🇷Thessaloniki, Greece
Local Institution - 0021
🇮🇹Rozzano, MI, Italy
Local Institution - 0071
🇮🇹Meldola, Italy
Local Institution - 0029
🇮🇹Pozzuoli, Italy
Local Institution - 0016
🇮🇹Modena, Italy
Local Institution - 0075
🇬🇧Brighton, BNH, United Kingdom
Local Institution - 0074
🇳🇱Dordrecht, ZH, Netherlands
Local Institution - 0064
🇬🇧Blackburn, LAN, United Kingdom
Local Institution - 0030
🇬🇧Preston, LAN, United Kingdom
Local Institution - 0048
🇬🇧London, LND, United Kingdom
Local Institution - 0073
🇬🇧West Midlands, WLV, United Kingdom
Local Institution - 0063
🇬🇧Truro, United Kingdom
Texas Oncology
🇺🇸Flower Mound, Texas, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0035
🇬🇧Sutton, United Kingdom
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States