RECRUITING

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)

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Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)Prostatic Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the efficacy and safety of opevesostat 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 hypothesis is that opevesostat 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), 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)

Quick Facts

Study Start:2023-12-18
Study Completion:2030-12-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06136650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
  2. * Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
  3. * 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)
  4. * 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
  5. * 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
  6. * Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
  7. * Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
  8. * Has adequate organ function
  9. * 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
  10. * 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
  11. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  12. * 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 or ≤Grade 2 osteopenia/osteoporosis are eligible
  13. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  1. * Has presence of gastrointestinal condition
  2. * Is unable to swallow capsules/tablets
  3. * Has history of pituitary dysfunction
  4. * Has poorly controlled diabetes mellitus
  5. * Has clinically significant abnormal serum potassium or sodium level
  6. * 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
  7. * Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
  8. * History or family history of long QTc syndrome
  9. * 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
  10. * Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
  11. * Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
  12. * Has not adequately recovered from major surgery or have ongoing surgical complications
  13. * Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
  14. * Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
  15. * Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
  16. * Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  17. * 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
  18. * Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
  19. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  20. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  21. * Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
  22. * 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
  23. * Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  24. * 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
  25. * 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
  26. * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
  27. * Active infection requiring systemic therapy
  28. * Has concurrent active Hepatitis B virus and Hepatitis C virus infection

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

The University of Arizona Cancer Center - North Campus ( Site 0073)
Tucson, Arizona, 85719
United States
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, California, 90404
United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
Orange, California, 92868
United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)
Orange, California, 92868
United States
Stanford Cancer Center ( Site 0036)
Palo Alto, California, 94304
United States
Emad Ibrahim,MD,INC. ( Site 0012)
Redlands, California, 92373
United States
Kaiser Permanente Riverside Medical Center ( Site 0099)
Riverside, California, 92505
United States
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)
Sacramento, California, 95817
United States
San Francisco VA Health Care System ( Site 0093)
San Francisco, California, 94121
United States
Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
Vallejo, California, 94589
United States
University of Colorado Anschutz Medical Campus ( Site 0046)
Aurora, Colorado, 80045
United States
UCHealth Highlands Ranch Hospital ( Site 0111)
Highlands Ranch, Colorado, 80129
United States
Colorado Clinical Research ( Site 0067)
Lakewood, Colorado, 80228
United States
University of Colorado Health - Lone Tree Medical Center ( Site 0112)
Lone Tree, Colorado, 80124
United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
New Haven, Connecticut, 06510
United States
MedStar Washington Hospital Center ( Site 0103)
Washington D.C., District of Columbia, 20010
United States
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, 33901
United States
Mount Sinai Cancer Center ( Site 0107)
Miami Beach, Florida, 33140
United States
Memorial Hospital West-Memorial Cancer Institute ( Site 0109)
Pembroke Pines, Florida, 33028
United States
Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
Atlanta, Georgia, 30342
United States
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
Elmhurst, Illinois, 60126
United States
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
Naperville, Illinois, 60540
United States
Illinois Cancer Care ( Site 0104)
Peoria, Illinois, 61615
United States
Urology of Indiana - Carmel ( Site 0055)
Carmel, Indiana, 46032
United States
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, 40536
United States
Baltimore Veterans Affairs Medical Center ( Site 0069)
Baltimore, Maryland, 21201
United States
Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland, 21201
United States
Chesapeake Urology ( Site 0009)
Towson, Maryland, 21204
United States
Henry Ford Hospital ( Site 0015)
Detroit, Michigan, 48202
United States
Cancer and Hematology Centers of Western Michigan ( Site 0005)
Grand Rapids, Michigan, 49503
United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
Saint Louis Park, Minnesota, 55426
United States
HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
Saint Paul, Minnesota, 55101
United States
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana, 59102
United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska, 68130
United States
OptumCare Cancer Care-Research Department ( Site 0078)
Las Vegas, Nevada, 89102
United States
Comprehensive Cancer Centers of Nevada ( Site 0010)
Las Vegas, Nevada, 89148
United States
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, New Jersey, 08901
United States
Associated Medical Professionals - Urology ( Site 0081)
Syracuse, New York, 13210
United States
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, Ohio, 44106
United States
Central Ohio Urology Group - Gahanna ( Site 0098)
Gahanna, Ohio, 43230
United States
Genesis Healthcare System ( Site 0102)
Zanesville, Ohio, 43701
United States
MidLantic urology ( Site 0022)
Bala-Cynwyd, Pennsylvania, 19004
United States
Fox Chase Cancer Center ( Site 0076)
Philadelphia, Pennsylvania, 19111
United States
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
Charleston, South Carolina, 29401
United States
Avera Cancer Institute - Pierre ( Site 0118)
Pierre, South Dakota, 57501
United States
Avera Cancer Institute- Research ( Site 0094)
Sioux Falls, South Dakota, 57105
United States
Avera Cancer Institute - Yankton ( Site 0117)
Yankton, South Dakota, 57078
United States
The West Clinic, PLLC dba West Cancer Center ( Site 0063)
Germantown, Tennessee, 38138
United States
Texas Oncology - Central/South Texas ( Site 8003)
Austin, Texas, 78731
United States
Texas Oncology - DFW ( Site 8001)
Dallas, Texas, 75246
United States
Texas Oncology - Gulf Coast ( Site 8002)
Houston, Texas, 77024
United States
University of Virginia Health System ( Site 0054)
Charlottesville, Virginia, 22908
United States
Inova Schar Cancer Institute ( Site 0017)
Fairfax, Virginia, 22031
United States
Virginia Cancer Specialists (VCS) ( Site 8004)
Fairfax, Virginia, 22031
United States
VCU Health Adult Outpatient Pavillion ( Site 0061)
Richmond, Virginia, 23219
United States
Blue Ridge Cancer Care ( Site 0004)
Roanoke, Virginia, 24014
United States
Spokane Urology ( Site 0035)
Spokane, Washington, 99202
United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
Vancouver, Washington, 98684
United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-18
Study Completion Date2030-12-02

Study Record Updates

Study Start Date2023-12-18
Study Completion Date2030-12-02

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Prostatic Neoplasms