19-043 - Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
Status: openA Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
Treatment for Lung Cancer
Description
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. |
Sponsors
This trial is sponsored by Merck.Interested in Clinical Trial?
Contact the Clinical Trial Coordinator
If you have questions get in touch with this Clinical Trial’s Coordinator by phone at (251) 445-9834 or by email at wlblount@health.southalabama.edu.
Providers Associated With This Trial
Principle Investigator
![Moh'd Khushman]()
View ProfileMoh'd Khushman, M.D.Medical Oncologist and HematologistAssociate Professor of Interdisciplinary Clinical Oncology
Sub Investigators
![Sachin Pai]()
View ProfileSachin Pai, M.D., M.S.C.I.Medical OncologistProgram Leader of Developmental Therapeutics; Assistant Professor of Interdisciplinary Clinical Oncology
