Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Part of paid clinical trials in Orange, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06136624
Phase
PHASE3
Status
Recruiting
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Conditions

  • Prostate Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opevesostat — DRUG
    Administered orally
  • Abiraterone acetate — DRUG
    Administered orally
  • Enzalutamide — DRUG
    Administered orally
  • Hydrocortisone — DRUG
    Administered orally or IM as a rescue medication
  • Fludrocortisone acetate — DRUG
    Administered orally
  • Prednisone — DRUG
    Administered orally
  • Dexamethasone — DRUG
    Administered orally as rescue medication

Study Details

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Key Dates

Start date
Dec 31, 2023
Status verified
May 2026
Primary completion
Aug 2, 2028
Completion
Feb 15, 2030

Study Design

Enrollment
1,310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Opevesostat
    Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.
  • Active Comparator: Abiraterone Acetate or Enzalutamide
    Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.

Primary Outcome Measure

Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants [ Time Frame: Up to ~54 months ]

Central Contacts

Locations (44)

FacilityCityStateZIPSite coordinators
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)OrangeCalifornia92868-
Stanford Cancer Center ( Site 0036)Palo AltoCalifornia94304
Study Coordinator
650-725-2078
Kaiser Permanente Riverside Medical Center ( Site 0099)RiversideCalifornia92505
Study Coordinator
951-809-8361
Anschutz Cancer Pavilion ( Site 0046)AuroraColorado80045
Study Coordinator
302-290-3598
University of Colorado Health - Highlands Ranch Hospital ( Site 0111)Highlands RanchColorado80129
Study Coordinator
302-290-3598
Colorado Clinical Research ( Site 0067)LakewoodColorado80228-
University of Colorado Health - Lone Tree Medical Center ( Site 0112)Lone TreeColorado80124
Study Coordinator
720-848-5146
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)New HavenConnecticut06510
Study Coordinator
203-737-8076
Florida Cancer Specialists - South ( Site 7003)Fort MyersFlorida33901
Study Coordinator
727-364-9201
Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)MiamiFlorida33125-
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)MiamiFlorida33136
Study Coordinator
305-243-1543
University of Chicago Medical Center ( Site 0045)ChicagoIllinois60637
Study Coordinator
773-702-7609
University of Illinois at Chicago ( Site 0105)ChicagoIllinois60612
Study Coordinator
973-330-2391
University of Iowa ( Site 0047)Iowa CityIowa52242
Study Coordinator
319-353-8155
University of Kentucky Chandler Medical Center ( Site 0048)LexingtonKentucky40536-
Ochsner Clinic Foundation ( Site 0108)New OrleansLouisiana70121-
Baltimore Veterans Affairs Medical Center ( Site 0069)BaltimoreMaryland21201
Study Coordinator
410-707-4011
Greenebaum Comprehensive Cancer Center ( Site 0049)BaltimoreMaryland21201
Study Coordinator
410-707-4011
Henry Ford Hospital ( Site 0015)DetroitMichigan48202-
M Health Fairview Clinics and Surgery Center ( Site 0019)MinneapolisMinnesota55455
Study Coordinator
612-626-1422
Metro-Minnesota Community Clinical Oncology ( Site 0014)Saint Louis ParkMinnesota55416
Study Coordinator
952-993-3252
Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062)St LouisMissouri63110-
University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095)OmahaNebraska68105
Study Coordinator
402-559-8500
Comprehensive Cancer Centers of Nevada ( Site 0010)Las VegasNevada89148
Study Coordinator
702-952-1251
Atlantic Health System Morristown Medical Center ( Site 0115)MorristownNew Jersey07960
Study Coordinator
973-971-7960
Rutgers Cancer Institute of New Jersey ( Site 0033)New BrunswickNew Jersey08901-
James J. Peters VA Medical Center ( Site 0088)The BronxNew York10468
Study Coordinator
718-584-9000
University Hospitals Cleveland Medical Center ( Site 0043)ClevelandOhio44106
Study Coordinator
216-844-3951
Oregon Health and Science University ( Site 0028)PortlandOregon97239-
VA Portland Health Care System ( Site 0058)PortlandOregon97239
Study Coordinator
503-220-8262
AHN Allegheny General Hospital ( Site 0001)PittsburghPennsylvania15212-
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)CharlestonSouth Carolina29401-
Avera Cancer Institute - Pierre ( Site 0118)PierreSouth Dakota57501
Study Coordinator
605-224-3370
Avera Cancer Institute- Research ( Site 0094)Sioux FallsSouth Dakota57105
Study Coordinator
605-322-6900
Avera Cancer Institute - Yankton ( Site 0117)YanktonSouth Dakota57078
Study Coordinator
605-655-1800
SCRI Oncology Partners ( Site 7000)NashvilleTennessee37203
Study Coordinator
615-218-4647
Texas Oncology - Central/South Texas ( Site 8003)AustinTexas78731
Study Coordinator
512-427-9400
Texas Oncology - DFW ( Site 8001)DallasTexas75246-
Texas Oncology - Gulf Coast ( Site 8002)The WoodlandsTexas77380
Study Coordinator
713-467-1722
University of Virginia Health System ( Site 0054)CharlottesvilleVirginia22908
Study Coordinator
434-327-3029
VCU Health Adult Outpatient Pavillion ( Site 0061)RichmondVirginia23219-
Blue Ridge Cancer Care ( Site 0004)RoanokeVirginia24014
Study Coordinator
540-982-0237
Fred Hutchinson Cancer Center ( Site 0013)SeattleWashington98109
Study Coordinator
617-413-9079
MEDICAL COLLEGE OF WISCONSIN ( Site 0020)MilwaukeeWisconsin53226
Study Coordinator
414-805-4600

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