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) (NCT06353386)
MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCSD Moores Cancer Center ( Site 0039) — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (77 Sites)
Showing the first 25 of 77 sites.
- UCSD Moores Cancer Center ( Site 0039) — La Jolla, California
- UCLA Hematology/Oncology - Santa Monica ( Site 0044) — Los Angeles, California
- University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) — Miami, Florida
- University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) — Baltimore, Maryland
- Rutgers Cancer Institute of New Jersey ( Site 0033) — New Brunswick, New Jersey
- University Hospitals Cleveland Medical Center ( Site 0043) — Cleveland, Ohio
- MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020) — Milwaukee, Wisconsin
- Macquarie University-MQ Health Clinical Trials Unit ( Site 0108) — Macquarie University, New South Wales
- Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107) — Greenslopes, Queensland
- Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110) — Melbourne, Victoria
- Centre Hospitalier de l'Université de Montréal ( Site 0200) — Montreal, Quebec
- Jewish General Hospital ( Site 0206) — Montreal, Quebec
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207) — Québec, Quebec
- CIDO SpA-Oncology ( Site 0302) — Temuco, Biobio
- Clinica Universidad Catolica del Maule-Oncology ( Site 0304) — Talca, Maule Region
- FALP ( Site 0301) — Santiago, Region M. de Santiago
- Pontificia Universidad Catolica de Chile ( Site 0303) — Santiago, Region M. de Santiago
- Bradfordhill ( Site 0300) — Santiago, Region M. de Santiago
- FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406) — Bogotá, Bogota D.C.
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402) — Bogotá, Bogota D.C.
- Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400) — Valledupar, Cesar Department
- IMAT S.A.S ( Site 0404) — Montería, Departamento de Córdoba
- Fundación Valle del Lili-Oncology CIC ( Site 0403) — Cali, Valle del Cauca Department
- Herlev and Gentofte Hospital ( Site 0501) — Copenhagen, Capital Region
- Aalborg Universitetshospital, Syd ( Site 0503) — Aalborg, North Denmark
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostatic Neoplasms, Castration-Resistant
- A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer — Tucson, Arizona
- A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer — Chandler, Arizona
- A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan — East Hanover, New Jersey
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) — Stanford, California
- Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer — New York, New York
- A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer — East Hanover, New Jersey
Explore by condition: All Prostatic Neoplasms, Castration-Resistant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.