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Study identifier: NCT06353386 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

Condition: Prostatic Neoplasms, Castration-Resistant  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 1/Phase 2
Planned participants220
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

This description comes directly from the study's public registry record.

Talk to the study team

Toll Free Number  ·  1-888-577-8839  ·  Trialsites@msd.com

Always discuss trial participation with your own doctor first.

Locations (77)

UCSD Moores Cancer Center ( Site 0039)La Jolla, California, United StatesRecruiting
UCLA Hematology/Oncology - Santa Monica ( Site 0044)Los Angeles, California, United StatesRecruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)Miami, Florida, United StatesRecruiting
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)Baltimore, Maryland, United StatesActive Not Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0033)New Brunswick, New Jersey, United StatesActive Not Recruiting
University Hospitals Cleveland Medical Center ( Site 0043)Cleveland, Ohio, United StatesRecruiting
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)Milwaukee, Wisconsin, United StatesRecruiting
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)Macquarie University, New South Wales, AustraliaRecruiting
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)Greenslopes, Queensland, AustraliaRecruiting
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)Melbourne, Victoria, AustraliaRecruiting
Centre Hospitalier de l'Université de Montréal ( Site 0200)Montreal, Quebec, CanadaRecruiting
Jewish General Hospital ( Site 0206)Montreal, Quebec, CanadaRecruiting

+ 65 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06353386