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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) - rechARge1

Clinical Trials.gov ID NCT06764485

RechARge is a Phase 3, Two-part, Randomized, Open-label, Adaptive Study of people with Metastatic Castration-resistant Prostate Cancer comparing the efficacy & safety  of:

BMS-986365 AR LDD (Androgen Receptor-Ligand Directed Degrader)

vs

Investigator’s Choice Options:​

  • Docetaxel + Prednisone/Prednisolone​
  • Enzalutamide or Abiraterone + Prednisone/Prednisolone

Part 1

Randomization 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator’s choice)

Part 2

Randomization 1:1 between BMS-986365​ selected dose, or to the active comparator arm​ (investigator’s choice)

Study Endpoints

Primary Endpoint

Assess rPFS, by BICR, (RECIST 1.1 for soft tissue, PCWG3 for bone), of BMS-986365 versus ​investigator’s choice therapy.

Select Secondary Endpoints

Efficacy
  • Overall Survival​
  • Progression-free survival​
  • Confirmed overall response rate by BICR assessment​ in participants with measurable disease using RECIST​ 1.1 (soft tissue) and PCWG3 (bone) criteria​
  • Time to symptomatic progression​
  • Prostate-specific antigen response rate​
Quality of Life
  • Change from baseline in Functional​Assessment of Cancer Therapy – Prostate​ Cancer total scores and Prostate Cancer​ Subscale scores​
  • Change from baseline in Brief Pain Inventory -​ Short Form worst pain (item #3) intensity
Safety
  • Incidence of adverse events and serious adverse events

Estimated Enrollment: 960 patients

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Key Inclusion Criteria

  • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.​
  • Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).​
  • Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.​
  • Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).​
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Key Exclusion Criteria

  • Participants must not have impaired cardiac function or clinically significant cardiac disease.​
  • Participants must not have any brain metastasis.
  • Participants must not have any liver metastasis.​
  • Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans

*Other protocol-defined inclusion-exclusion criteria may apply

rechARge Trial Schema

Study CA071-1000 is recruiting adults with Metastatic Castration-Resistant Prostate Cancer

rechARge Trial Schema rechARge Trial Schema

For further details on this trial, visit BMSClinicalTrials.com >

References

  1. Kim Nguyen Chi, Rana R McKay, Shahneen Sandhu, Jose A Arranz, Philippe Barthélémy, Boris Hadaschik, Nobuaki Matsubara, Neal D Shore, Dingwei Ye, Teresa Cascella, Irina Irincheeva, Stephanie Kreiser, Antoine Thiery-Vuillemin & Dana E Rathkopf (02 Jun 2025): rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator’s choice in patients with mCRPC, Future Oncology, DOI: 10.1080/14796694.2025.2502318.

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This website is for US physicians to provide general information about ongoing BMS clinical trials and as an exchange of scientific information related to BMS investigational product BMS-986365. BMS-986365 is not currently approved in any market and has not been approved by the FDA.

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