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)
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)
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 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.
Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Trialsites@msd.com1-888-577-8839
Tucson, Arizona 85719, United States
520-626-1068
Irvine, California 92612, United States
Los Angeles, California 90404, United States
Orange, California 92868, United States
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San Francisco, California 94121, United States
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Aurora, Colorado 80045, United States
Highlands Ranch, Colorado 80129, United States
Lone Tree, Colorado 80124, United States
New Haven, Connecticut 06510, United States
Washington D.C., District of Columbia 20010, United States
Miami Beach, Florida 33140, United States
Pembroke Pines, Florida 33028, United States
Atlanta, Georgia 30342, United States
Elmhurst, Illinois 60126, United States
Naperville, Illinois 60540, United States
Lexington, Kentucky 40536, United States
Baltimore, Maryland 21201, United States
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Saint Louis Park, Minnesota 55426, United States
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Billings, Montana 59102, United States
Omaha, Nebraska 68130, United States
Las Vegas, Nevada 89102, United States
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Syracuse, New York 13210, United States
Cleveland, Ohio 44106, United States
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Germantown, Tennessee 38138, United States
Charlottesville, Virginia 22908, United States
Vancouver, Washington 98684, United States
Macquarie University, New South Wales 2109, Australia
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Melbourne, Victoria 3000, Australia
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Uberaba, Minas Gerais 38025-350, Brazil
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Bragança Paulista, São Paulo 12916-542, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Taubaté, São Paulo 12030-200, Brazil
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Talca, Maule Region 3465584, Chile
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Fuzhou, Fujian 350005, China
Guangzhou, Guangdong 510000, China
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Chengdu, Sichuan 610041, China
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Wenzhou, Zhejiang 325015, China
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Valledupar, Cesar Department 200001, Colombia
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