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

NCT06764485
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
960
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Lead sponsor
Celgene
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Start date
2025-03-13
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Number of sites
227
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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.
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Acronym
rechARge
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Short title
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
clinicaltrials.gov
Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-01-19
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First posted
2025-01-08
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Registry last updated
2026-09-30
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Primary completion date
2027-09-12
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Start date
2025-03-13
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Participants
960
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Participant count basis
Estimated
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Planned participants
960
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Protocol amendments
0
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Randomisation ratio
1:1:1
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Number of sites
227
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Celgene
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06764485
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ClinicalTrials.gov ID
NCT06764485
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. 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

    Timeframe: Up to 4 years

  1. Overall Survival (OS)

    Timeframe: Up to 4 years

  2. Recommended dose of BMS-986365 for Part 2

    Timeframe: Up to approximately 1.5 years

  3. Progression-free survival (PFS)

    Timeframe: Up to 4 years

  4. Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria

    Timeframe: Up to 4 years

  5. Time to pain progression (TTPP)

    Timeframe: Up to 4 years

  6. Time to symptomatic progression (TTSP)

    Timeframe: Up to 4 years

  7. Time to initiation of the first subsequent systemic therapy (TFST)

    Timeframe: Up to 4 years

  8. Prostate-specific antigen (PSA) response rate

    Timeframe: Up to 4 years

  9. Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores

    Timeframe: Up to 4 years

  10. Change from baseline in Prostate Cancer Subscale (PCS) scores

    Timeframe: Up to 4 years

  11. Change from baseline in trial outcome index (TOI)

    Timeframe: Up to 4 years

  12. Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity

    Timeframe: Up to 4 years

  13. Incidence of adverse events (AEs)

    Timeframe: Up to 4 years

  14. Incidence of serious adverse events (SAEs)

    Timeframe: Up to 4 years

  15. Incidence of AEs leading to dose modifications

    Timeframe: Up to 4 years

  16. Incidence of AEs leading to interruptions

    Timeframe: Up to 4 years

  17. Incidence of AEs leading to discontinuation

    Timeframe: Up to 4 years

  18. Electrocardiogram (ECG) findings

    Timeframe: Up to 4 years

    ECG Findings defined as : * Number of Postbaseline Abnormal Corrected QT (QTc) Values * Number of abnormal Beats Per Minute (BPM)

  19. Incidence of laboratory abnormalities

    Timeframe: Up to 4 years

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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).

  • 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 apply.
Sources for eligibility
clinicaltrials.gov

  • Local Institution - 0330Birmingham, United States
  • Local Institution - 0329Gilbert, United States
  • Local Institution - 0370Anaheim, United States
  • Local Institution - 0015La Jolla, United States
  • Local Institution - 0224Los Alamitos, United States
  • Local Institution - 0016San Francisco, United States
  • Local Institution - 0411San Francisco, United States
  • Local Institution - 0238Aurora, United States
  • Local Institution - 0294Denver, United States
  • Local Institution - 0419Lakewood, United States
  • Local Institution - 0413Washington D.C., United States
  • Local Institution - 0426Lakeland, United States
  • Local Institution - 0077Athens, United States
  • Local Institution - 0048Chicago, United States
  • Local Institution - 0331Westwood, United States
  • Local Institution - 0060Wichita, United States
  • Local Institution - 0054Baltimore, United States
  • Local Institution - 0019Baltimore, United States
  • Local Institution - 0344Frederick, United States
  • Local Institution - 0429Sewell, United States
  • Local Institution - 0081Albuquerque, United States
  • Local Institution - 0334Albuquerque, United States
  • Local Institution - 0197Buffalo, United States
  • Local Institution - 0412Mineola, United States
  • Local Institution - 0069New York, United States

And 202 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1311-0532
  • 2024-517422-25
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (2)

Targets (23)