drugset / Trial / NCT06764485
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-13
- Primary completion
- 2027-09-12
- Completion
- 2029-01-19
Publications
- Background Rathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ. Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2025 Jan;36(1):76-88. doi: 10.1016/j.annonc.2024.09.005. Epub 2024 Sep 16.
- Background 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.
- Chi KN, McKay RR, Sandhu S, Arranz JA, Barthelemy P, Hadaschik B, Matsubara N, Shore ND, Ye D, Cascella T, Irincheeva I, Kreiser S, Thiery-Vuillemin A, Rathkopf DE. rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator's choice in patients with mCRPC. Future Oncol. 2025 Jun;21(14):1771-1777. doi: 10.1080/14796694.2025.2502318. Epub 2025 Jun 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abiraterone acetate | Small molecule | — | — |
| Subject | BMS-986365 | Other / unclassified | — | Oral |
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Enzalutamide | Other / unclassified | — | — |
| Comparator | Prednisolone | Other / unclassified | — | — |
| Comparator | Prednisone | Other / unclassified | — | — |