Prostate Cancer Clinical Trial

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

The purpose of this study is to assess the efficacy and safety of MK-5684 plus hormone replacement therapy (HRT) 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 hypotheses are that MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

View Eligibility Criteria

Eligibility Criteria

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 current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
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), for at least 8 weeks (at least 14 weeks 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 six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
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 therapy (HRT) or participants who have ≤Grade 2 neuropathy 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 a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
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
History or family history of long QTc syndrome
Has a history of seizure(s) within 6 months prior to signing the 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 and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
Has not adequately recovered from major surgery or have ongoing surgical complications
Has received prior treatment with radium for prostate cancer
Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
Participants on an unstable dose of thyroid hormone therapy 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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1500

Study ID:

NCT06136650

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 50 Locations for this study

See Locations Near You

Emad Ibrahim,MD,INC. ( Site 0012)
Redlands California, 92373, United States More Info
Study Coordinator
Contact
909-478-7973
Colorado Clinical Research ( Site 0067)
Lakewood Colorado, 80228, United States More Info
Study Coordinator
Contact
303-885-9828
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
Elmhurst Illinois, 60126, United States More Info
Study Coordinator
Contact
630-527-3788
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
Naperville Illinois, 60540, United States More Info
Study Coordinator
Contact
630-527-3788
Baltimore Veterans Affairs Medical Center ( Site 0069)
Baltimore Maryland, 21201, United States More Info
Study Coordinator
Contact
410-707-4011
Chesapeake Urology ( Site 0009)
Towson Maryland, 21204, United States More Info
Study Coordinator
Contact
443-471-5741
Cancer and Hematology Centers of Western Michigan ( Site 0005)
Grand Rapids Michigan, 49503, United States More Info
Study Coordinator
Contact
616-399-6500
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
Saint Louis Park Minnesota, 55426, United States More Info
Study Coordinator
Contact
952-993-1290
HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
Saint Paul Minnesota, 55101, United States More Info
Study Coordinator
Contact
952-993-1290
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings Montana, 59102, United States More Info
Study Coordinator
Contact
406-238-6290
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha Nebraska, 68130, United States More Info
Study Coordinator
Contact
402-334-4773
OptumCare Cancer Care-Research Department ( Site 0078)
Las Vegas Nevada, 89102, United States More Info
Study Coordinator
Contact
973-330-2391
Comprehensive Cancer Centers of Nevada ( Site 0010)
Las Vegas Nevada, 89148, United States More Info
Study Coordinator
Contact
702-952-1251
The West Clinic, PLLC dba West Cancer Center ( Site 0063)
Germantown Tennessee, 38138, United States More Info
Study Coordinator
Contact
901-683-0055
Urology Clinics of North Texas, PLLC ( Site 0077)
Dallas Texas, 75246, United States More Info
Study Coordinator
Contact
214-580-1391
University of Virginia Health System ( Site 0054)
Charlottesville Virginia, 22908, United States More Info
Study Coordinator
Contact
434-327-3029
Blue Ridge Cancer Care ( Site 0004)
Roanoke Virginia, 24014, United States More Info
Study Coordinator
Contact
540-982-0237
Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
Macquarie University New South Wales, 2109, Australia More Info
Study Coordinator
Contact
0402856430
First Medical Center of Chinese PLA General Hospital ( Site 1601)
Beijing Beijing, 10085, China More Info
Study Coordinator
Contact
13693556315
Hubei Cancer Hospital-Urinary surgery ( Site 1631)
Wuhan Hubei, 43007, China More Info
Study Coordinator
Contact
8613907110640
Nanchong Central Hospital-urology ( Site 1647)
Nanchong Sichuan, 63700, China More Info
Study Coordinator
Contact
0817-2606822
Zhejiang Provincial People's Hospital-Urology ( Site 1641)
Hangzhou Zhejiang, 31001, China More Info
Study Coordinator
Contact
13858019285
The First Hospital of Jiaxing-urology ( Site 1605)
Jiaxing Zhejiang, 31400, China More Info
Study Coordinator
Contact
13957391616
Ningbo First Hospital-Urology ( Site 1608)
Ningbo Zhejiang, 31501, China More Info
Study Coordinator
Contact
15958800971
CIMCA-Hemato-Oncology ( Site 0380)
San José San Jose, 10103, Costa Rica More Info
Study Coordinator
Contact
50683893636
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
Avignon Vaucluse, 84918, France More Info
Study Coordinator
Contact
33490276090
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
Munich Bayern, 81675, Germany More Info
Study Coordinator
Contact
498941402522
Vivantes Klinikum Am Urban ( Site 0512)
Berlin , 10967, Germany More Info
Study Coordinator
Contact
4930130226301
CELAN,S.A ( Site 0579)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
502 42142081
Queen Mary Hospital ( Site 0602)
Hksar , , Hong Kong More Info
Study Coordinator
Contact
85222556220
Emek Medical Center ( Site 0680)
Afula , 18341, Israel More Info
Study Coordinator
Contact
+97246495540
Rambam Health Care Campus-Oncology Division ( Site 0676)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247776750
Shaare Zedek Medical Center ( Site 0679)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
97286400798
Hadassah Medical Center ( Site 0683)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
972505172315
Meir Medical Center ( Site 0682)
Kfar Saba , 44281, Israel More Info
Study Coordinator
Contact
972-9-7471606
Rabin Medical Center ( Site 0678)
Petah Tikva , 49414, Israel More Info
Study Coordinator
Contact
97239378074
Sheba Medical Center ( Site 0677)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
0525505090
Sourasky Medical Center ( Site 0681)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
97236947284
National Cancer Center-Center for Urologic Cancer ( Site 1254)
Goyang-si Kyonggi-do, 10408, Korea, Republic of More Info
Study Coordinator
Contact
82-31-920-1740
Seoul National University Bundang Hospital-Urology ( Site 1253)
Seongnam Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
82-31-787-7342
Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of More Info
Study Coordinator
Contact
+82532002400
Seoul National University Hospital-Urology ( Site 1251)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82-053-3027
Hospital CUF - Tejo ( Site 1157)
Lisboa , 1350-, Portugal More Info
Study Coordinator
Contact
966606539
Advance Urology and Laparoscopic Center ( Site 1178)
Ponce , 00716, Puerto Rico More Info
Study Coordinator
Contact
7874329059
Ad-Vance Medical Research-Research ( Site 1177)
Ponce , 00717, Puerto Rico More Info
Study Coordinator
Contact
7876516697
Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
San Juan , 00909, Puerto Rico More Info
Study Coordinator
Contact
7876745868
Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)
Craiova Dolj, 20074, Romania More Info
Study Coordinator
Contact
40727774974
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
+34914521987
Hospital Quirón Málaga ( Site 1286)
Málaga Malaga, 29004, Spain More Info
Study Coordinator
Contact
00349422033350000
China Medical University Hospital-Department of Urology ( Site 1335)
Taichung , 40447, Taiwan More Info
Study Coordinator
Contact
886-975-681295
Taipei Veterans General Hospital ( Site 1332)
Taipei , 112, Taiwan More Info
Study Coordinator
Contact
886228757519304

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1500

Study ID:

NCT06136650

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.