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
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
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.
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).
Inclusion Criteria
Exclusion Criteria
Clinical.Trials@bms.com855-907-3286
Birmingham, Alabama 35209, United States
205-502-4700
Sewell, New Jersey 08080, United States
Albuquerque, New Mexico 87106, United States
Albuquerque, New Mexico 87109, United States
Mineola, New York 11501, United States
Philadelphia, Pennsylvania 19104, United States
Philadelphia, Pennsylvania 19107, United States
CABA, Buenos Aires CP1280AEB, Argentina
54911563819972
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ, Argentina
5432218900
ABB, Buenos Aires F.D. C1199ABB, Argentina
054911555933332
Macquarie University, New South Wales 2109, Australia
+61298122956
Port Macquarie, New South Wales 2444, Australia
Greenslopes, Queensland 4120, Australia
Québec, Quebec G1J 1Z4, Canada
Rimouski, Quebec G5L 5T1, Canada
Nanjing, Jiangsu 210000, China
Nanchang, Jiangxi 330209, China
Vandœuvre-lès-Nancy, Lorraine 54519, France
Clermont-Ferrand, 63011, France
Kita-gun, Kagawa-ken 761-0793, Japan
Bunkyo-ku, Tokyo 1138603, Japan
Koto-ku, Tokyo 135-8550, Japan
Shinjuku-ku, Tokyo 1608582, Japan
Toyoma, Toyama 930-0194, Japan
Opole, Opole Voivodeship 45-061, Poland
Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea
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