19-042 - Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Status: openA Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE921)
Treatment for Prostrate Cancer
Description
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone 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
View Profile
Moh'd Khushman, M.D.Medical Oncologist and HematologistAssociate Professor of Interdisciplinary Clinical Oncology
Sub Investigators
View Profile
Sachin Pai, M.D., M.S.C.I.Medical OncologistProgram Leader of Developmental Therapeutics; Assistant Professor of Interdisciplinary Clinical Oncology