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RECRUITING

NCT06136650

PHASE3

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Official title: MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1314

Start Date

2023-12-18

Completion Date

2030-12-02

Last Updated

2026-10-20

Healthy Volunteers

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)Prostatic Neoplasms

Interventions

DRUG

Opevesostat

Administered orally

DRUG

Dexamethasone

Administered orally

DRUG

Fludrocortisone acetate

Administered orally

DRUG

Hydrocortisone

Administered orally or IM as a rescue drug

DRUG

Abiraterone acetate

Administered orally

DRUG

Prednisone acetate

Administered orally

DRUG

Enzalutamide

Administered orally

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology * Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening * Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI) * Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel * Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment * Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM) * Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization * Has adequate organ function * Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has presence of gastrointestinal condition * Is unable to swallow capsules/tablets * Has history of pituitary dysfunction * Has poorly controlled diabetes mellitus * Has clinically significant abnormal serum potassium or sodium level * Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy * Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events * History or family history of long QTc syndrome * Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment * Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place * Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) * Has not adequately recovered from major surgery or have ongoing surgical complications * Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures * Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention * Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids * Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention * Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat * Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed * Active infection requiring systemic therapy * Has concurrent active Hepatitis B virus and Hepatitis C virus infection

Locations (330)

The University of Arizona Cancer Center - North Campus ( Site 0073)

Tucson, Arizona, United States

CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 0120)

Irvine, California, United States

UCLA Hematology/Oncology - Santa Monica ( Site 0044)

Los Angeles, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)

Orange, California, United States

Stanford Cancer Center ( Site 0036)

Palo Alto, California, United States

Emad Ibrahim,MD,INC. ( Site 0012)

Redlands, California, United States

Kaiser Permanente Riverside Medical Center ( Site 0099)

Riverside, California, United States

University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)

Sacramento, California, United States

San Francisco VA Health Care System ( Site 0093)

San Francisco, California, United States

Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)

Vallejo, California, United States

University of Colorado Anschutz Medical Campus ( Site 0046)

Aurora, Colorado, United States

UCHealth Highlands Ranch Hospital ( Site 0111)

Highlands Ranch, Colorado, United States

Colorado Clinical Research ( Site 0067)

Lakewood, Colorado, United States

University of Colorado Health - Lone Tree Medical Center ( Site 0112)

Lone Tree, Colorado, United States

Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)

New Haven, Connecticut, United States

MedStar Washington Hospital Center ( Site 0103)

Washington D.C., District of Columbia, United States

Florida Cancer Specialists - South ( Site 7003)

Fort Myers, Florida, United States

Mount Sinai Braman Comprehensive Cancer Center ( Site 0107)

Miami Beach, Florida, United States

Memorial Hospital West-Memorial Cancer Institute ( Site 0109)

Pembroke Pines, Florida, United States

Northside Hospital-Northside Hospital Oncology Network ( Site 0100)

Atlanta, Georgia, United States

Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)

Elmhurst, Illinois, United States

Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)

Naperville, Illinois, United States

Illinois Cancer Care ( Site 0104)

Peoria, Illinois, United States

Urology of Indiana - Carmel ( Site 0055)

Carmel, Indiana, United States

University of Kentucky Chandler Medical Center ( Site 0048)

Lexington, Kentucky, United States

Baltimore Veterans Affairs Medical Center ( Site 0069)

Baltimore, Maryland, United States

Greenebaum Comprehensive Cancer Center ( Site 0049)

Baltimore, Maryland, United States

Chesapeake Urology ( Site 0009)

Towson, Maryland, United States

Henry Ford Hospital ( Site 0015)

Detroit, Michigan, United States

Cancer and Hematology Centers of Western Michigan ( Site 0005)

Grand Rapids, Michigan, United States

Avera Cancer Institute - Marshall ( Site 0122)

Marshall, Minnesota, United States

HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)

Saint Louis Park, Minnesota, United States

HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)

Saint Paul, Minnesota, United States

St. Vincent Frontier Cancer Center-Research ( Site 0037)

Billings, Montana, United States

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)

Omaha, Nebraska, United States

OptumCare Cancer Care-Research Department ( Site 0078)

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada ( Site 0010)

Las Vegas, Nevada, United States

Rutgers Cancer Institute of New Jersey ( Site 0033)

New Brunswick, New Jersey, United States

Associated Medical Professionals - Urology ( Site 0081)

Syracuse, New York, United States

University Hospitals Cleveland Medical Center ( Site 0043)

Cleveland, Ohio, United States

Central Ohio Urology Group - Gahanna ( Site 0098)

Gahanna, Ohio, United States

Genesis Healthcare System ( Site 0102)

Zanesville, Ohio, United States

MidLantic urology ( Site 0022)

Bala-Cynwyd, Pennsylvania, United States

Fox Chase Cancer Center ( Site 0076)

Philadelphia, Pennsylvania, United States

Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)

Charleston, South Carolina, United States

Avera Cancer Institute - Aberdeen ( Site 0123)

Aberdeen, South Dakota, United States

Avera Cancer Institute - Mitchell ( Site 0121)

Mitchell, South Dakota, United States

Avera Cancer Institute - Pierre ( Site 0118)

Pierre, South Dakota, United States

Avera Cancer Institute- Research ( Site 0094)

Sioux Falls, South Dakota, United States

Avera Cancer Institute - Yankton ( Site 0117)

Yankton, South Dakota, United States

The West Clinic, PLLC dba West Cancer Center ( Site 0063)

Germantown, Tennessee, United States

Texas Oncology - Central/South Texas ( Site 8003)

Austin, Texas, United States

Cancer Clinics of North Texas ( Site 0077)

Dallas, Texas, United States

Texas Oncology - DFW ( Site 8001)

Dallas, Texas, United States

Texas Oncology - Gulf Coast ( Site 8002)

Houston, Texas, United States

University of Virginia Health System ( Site 0054)

Charlottesville, Virginia, United States

Inova Schar Cancer Institute ( Site 0017)

Fairfax, Virginia, United States

Virginia Cancer Specialists (VCS) ( Site 8004)

Fairfax, Virginia, United States

VCU Health Adult Outpatient Pavillion ( Site 0061)

Richmond, Virginia, United States

Blue Ridge Cancer Care ( Site 0004)

Roanoke, Virginia, United States

Spokane Urology ( Site 0035)

Spokane, Washington, United States

Northwest Cancer Specialists (Compass Oncology) ( Site 8008)

Vancouver, Washington, United States

Medical College of Wisconsin ( Site 0020)

Milwaukee, Wisconsin, United States

Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)

Macquarie University, New South Wales, Australia

Westmead Hospital ( Site 0212)

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)

Brisbane, Queensland, Australia

Monash Health ( Site 0219)

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)

Melbourne, Victoria, Australia

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)

Fortaleza, Ceará, Brazil

Hospital Santa Rita de Cassia ( Site 0271)

Vitória, Espírito Santo, Brazil

Obras Sociais Irma Dulce ( Site 0255)

Salvador, Estado de Bahia, Brazil

Hospital São Domingos ( Site 0258)

São Luís, Maranhão, Brazil

Hospital Mario Penna ( Site 0264)

Belo Horizonte, Minas Gerais, Brazil

Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)

Uberaba, Minas Gerais, Brazil

ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)

Curitiba, Paraná, Brazil

Hospital Universitário Evangélico Mackenzie ( Site 0252)

Curitiba, Paraná, Brazil

Hospital São Lucas da PUCRS ( Site 0270)

Porto Alegre, Rio Grande do Sul, Brazil

Clínica de Neoplasias Litoral ( Site 0269)

Itajaí, Santa Catarina, Brazil

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)

Bragança Paulista, São Paulo, Brazil

Hospital de Base de São José do Rio Preto ( Site 0275)

São José do Rio Preto, São Paulo, Brazil

Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)

Taubaté, São Paulo, Brazil

Hospital Paulistano ( Site 0259)

São Paulo, Brazil

Cross Cancer Institute ( Site 0281)

Edmonton, Alberta, Canada

BC Cancer Abbotsford-Clinical Trials Unit ( Site 0287)

Abbotsford British Columbia, British Columbia, Canada

Trillium Health Partners - Credit Valley Hospital ( Site 0289)

Mississauga, Ontario, Canada

The Ottawa Hospital - General Campus ( Site 0286)

Ottawa, Ontario, Canada

Sunnybrook Research Institute ( Site 0285)

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0276)

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)

Québec, Quebec, Canada

CIDO SpA-Oncology ( Site 0302)

Temuco, Araucania, Chile

Clinica Universidad Catolica del Maule-Oncology ( Site 0306)

Talca, Maule Region, Chile

Fundación Arturo López Pérez ( Site 0303)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 0301)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0305)

Viña del Mar, Valparaiso, Chile

The Second Hospital Of Anhui Medical University ( Site 1633)

Hefei, Anhui, China

Peking University First Hospital-Urology ( Site 1602)

Beijing, Beijing Municipality, China

Beijing Cancer hospital-Urinary Surgery ( Site 1620)

Beijing, Beijing Municipality, China

First Medical Center of Chinese PLA General Hospital ( Site 1601)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 1623)

Beijing, Beijing Municipality, China

And 230 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (330)