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(s) studied
Investigational drug(s) / intervention(s)
Opevesostat: Oral Tablet
Olaparib: Oral Tablet
Docetaxel: IV Infusion
Cabazitaxel: IV Infusion
Fludrocortisone acetate: Oral Tablet
Dexamethasone: Oral Tablet
Prednisone: Oral Tablet
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number of participants who experience one or more dose-limiting toxicities (DLTs) — Up to approximately 28 days
The following events, if considered drug related by the investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not laboratory value); Grade 4 hematologic toxicity lasting \>7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia associated with clinically significant bleeding); Any nonhematologic adverse event (AE) \>Grade 3 in severity should be considered a DLT (with exceptions); Any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); Febrile neutropenia Grade 3 or Grade 4; Prolonged delay (\>2 weeks) in initiating treatment after the first 28 days due to study intervention-related toxicity; Missing \>25% of study intervention doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity. - Number of participants who experience one or more adverse events (AEs) — Up to approximately 46 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - Number of participants who discontinue study intervention due to an AE — Up to approximately 46 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - Prostate-specific antigen (PSA) response rate — Up to approximately 46 months
The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria.
Trial sites (77)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSD Moores Cancer Center ( Site 0039) | La Jolla | California | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 0044) | Los Angeles | California | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) | Miami | Florida | Recruiting |
| University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) | Baltimore | Maryland | Active Not Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0033) | New Brunswick | New Jersey | Active Not Recruiting |
| University Hospitals Cleveland Medical Center ( Site 0043) | Cleveland | Ohio | Recruiting |
| MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020) | Milwaukee | Wisconsin | Recruiting |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0108) | Macquarie University | New South Wales | Recruiting |
| Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107) | Greenslopes | Queensland | Recruiting |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110) | Melbourne | Victoria | Recruiting |
| Centre Hospitalier de l'Université de Montréal ( Site 0200) | Montreal | Quebec | Recruiting |
| Jewish General Hospital ( Site 0206) | Montreal | Quebec | Recruiting |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207) | Québec | Quebec | Recruiting |
| CIDO SpA-Oncology ( Site 0302) | Temuco | Biobio | Active Not Recruiting |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0304) | Talca | Maule Region | Recruiting |
| Fundación Arturo López Pérez ( Site 0301) | Santiago | Region M. de Santiago | Active Not Recruiting |
| Pontificia Universidad Catolica de Chile ( Site 0303) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 0300) | Santiago | Region M. de Santiago | Recruiting |
| FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406) | Bogotá | Bogota D.C. | Recruiting |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402) | Bogotá | Bogota D.C. | Recruiting |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400) | Valledupar | Cesar Department | Recruiting |
| IMAT S.A.S ( Site 0404) | Montería | Departamento de Córdoba | Recruiting |
| Fundación Valle del Lili-Oncology CIC ( Site 0403) | Cali | Valle del Cauca Department | Recruiting |
| Herlev and Gentofte Hospital ( Site 0501) | Copenhagen | Capital Region | Recruiting |
| Aalborg Universitetshospital, Syd ( Site 0503) | Aalborg | North Denmark | Recruiting |
| Vaasan Keskussairaala ( Site 0603) | Vaasa | Pohjanmaa | Recruiting |
| Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604) | Helsinki | Uusimaa | Recruiting |
| Docrates Syöpäsairaala ( Site 0602) | Helsinki | Uusimaa | Recruiting |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703) | Bordeaux | Aquitaine | Recruiting |
| Hopitaux Universitaires de Strasbourg ( Site 0700) | Strasbourg | Bas-Rhin | Recruiting |
| Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702) | Paris | France | Recruiting |
| Gustave Roussy ( Site 0701) | Villejuif | Île-de-France Region | Recruiting |
| Universitaetsklinikum Heidelberg ( Site 0805) | Heidelberg | Baden-Wurttemberg | Recruiting |
| Universitaetsklinikum Tuebingen-Urologie ( Site 0801) | Tübingen | Baden-Wurttemberg | Recruiting |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802) | Munich | Bavaria | Recruiting |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800) | Berlin | Germany | Active Not Recruiting |
| Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804) | Hamburg | Germany | Recruiting |
| St. Vincent's University Hospital ( Site 0901) | Dublin | Dublin | Recruiting |
| Cork University Hospital ( Site 0902) | Cork | Ireland | Recruiting |
| Tallaght University Hospital ( Site 0900) | Dublin | Ireland | Recruiting |
+ 37 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06353386 on ClinicalTrials.gov ↗ ← All trials in Italy