A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
Summary
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.
Detailed description
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide. In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).
Arms & interventions
- DrugBMS-986365
Specified dose on specified days
- DrugEnzalutamide
Specified dose on specified days
- DrugAbiraterone
Specified dose on specified days
- DrugDocetaxel
Specified dose on specified days
- DrugPredinsone/Prednisolone
Specified dose on specified days
Outcome measures
Primary
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Time frame: Up to 4 years
Secondary
Overall Survival (OS)
Time frame: Up to 4 years
Recommended dose of BMS-986365 for Part 2
Time frame: Up to approximately 1.5 years
Progression-free survival (PFS)
Time frame: Up to 4 years
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Time frame: Up to 4 years
Time to pain progression (TTPP)
Time frame: Up to 4 years
Time to symptomatic progression (TTSP)
Time frame: Up to 4 years
Time to initiation of the first subsequent systemic therapy (TFST)
Time frame: Up to 4 years
Prostate-specific antigen (PSA) response rate
Time frame: Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores
Time frame: Up to 4 years
Change from baseline in Prostate Cancer Subscale (PCS) scores
Time frame: Up to 4 years
Change from baseline in trial outcome index (TOI)
Time frame: Up to 4 years
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity
Time frame: Up to 4 years
Incidence of adverse events (AEs)
Time frame: Up to 4 years
Incidence of serious adverse events (SAEs)
Time frame: Up to 4 years
Incidence of AEs leading to dose modifications
Time frame: Up to 4 years
Incidence of AEs leading to interruptions
Time frame: Up to 4 years
Incidence of AEs leading to discontinuation
Time frame: Up to 4 years
Electrocardiogram (ECG) findings
Time frame: Up to 4 years
Incidence of laboratory abnormalities
Time frame: Up to 4 years
Eligibility criteria
Study locations (55)
Central Alabama Research
Birmingham, Alabama, 35209
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Local Institution - 0370
Anaheim, California, 92801
Moores Cancer Center
La Jolla, California, 92093
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Local Institution - 0364
Los Angeles, California, 90048
California Pacific Medical Center
San Francisco, California, 94115
San Francisco VA Health Care System
San Francisco, California, 94121
Local Institution - 0458
Santa Rosa, California, 95403
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Colorado Clinical Research
Lakewood, Colorado, 80228
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Local Institution - 0077
Athens, Georgia, 30607
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
Wichita Urology Group
Wichita, Kansas, 67226
Chesapeake Urology
Baltimore, Maryland, 21204
Johns Hopkins Hospital
Baltimore, Maryland, 21287
James M Stockman Cancer Institute
Frederick, Maryland, 21702
Local Institution - 0104
Minneapolis, Minnesota, 55455
Local Institution - 0049
Las Vegas, Nevada, 89148
Thomas Jefferson University, Kennedy Health Alliance
Sewell, New Jersey, 08080
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87106
New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, 87109
Roswell Park Cancer Institute
Buffalo, New York, 14263
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Local Institution - 0085
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Associated Medical Professionals - Urology
Syracuse, New York, 13210
Local Institution - 0056
Columbus, Ohio, 43210
Providence Portland Medical Center
Portland, Oregon, 97213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Local Institution - 0433
Allentown, Pennsylvania, 18103
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Hollings Cancer Center
Charleston, South Carolina, 29425
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Tennessee Oncology
Nashville, Tennessee, 37203
Texas Oncology - Central/South Texas
Austin, Texas, 78705
Urology Austin, PLLC
Austin, Texas, 78745
Local Institution - 0457
Houston, Texas, 77026
Local Institution - 0220
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Intermountain Medical Center
Murray, Utah, 84107
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
Local Institution - 0023
Richmond, Virginia, 23219
Local Institution - 0078
Seattle, Washington, 98109
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
References
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- Nayak S, Norris JD, Ammirante M, Rychak E, Wardell SE, Liao D, Toyama B, Kandimalla R, Christoforou A, Tsuji T, Liu K, Tran M, Meiring J, Reiss S, Piccotti JR, Baughman JM, Fontanillo C, Khater M, Mortensen DS, Cathers B, Bence N, Pierce DW, Plantevin-Krenitsky V, Rathkopf D, Hansen JD, Hamann LG, Narla RK, Arora VK, McDonnell DP, Rolfe M, Xu S. Discovery of BMS-986365, a First-in-Class Dual Androgen Receptor Ligand-Directed Degrader and Antagonist, for the Treatment of Advanced Prostate Cancer. Clin Cancer Res. 2026 Jan 6;32(1):224-241. doi: 10.1158/1078-0432.CCR-25-0471.(PubMed)
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