BMS-986365
DrugSpecified dose on specified days
NCT Number: NCT06764485
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 3
Hospital Británico de Buenos Aires, CABA, Buenos Aires, Argentina
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to approximately 1.5 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
Time frame: Up to 4 years
ECG Findings defined as :
Time frame: Up to 4 years
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Celgene
Industry
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
Acronym: rechARge
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06067841
Genital Diseases, Genital Diseases, Male
Palo Alto, California, United States
View Trial DetailsNCT07545811
Castration-resistant Prostate Cancer, Genital Diseases
St Louis, Missouri, United States
View Trial DetailsNCT07005154
Genital Diseases, Genital Diseases, Male
Huntsville, Alabama, United States
View Trial DetailsNCT07288359
Advanced CCNE1-amplified Solid Tumors, Advanced HR+/HER2- Breast Cancer
Nashville, Tennessee, United States
View Trial Details