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- (KEYNOTE-921) A 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)
Clinical Trial
(KEYNOTE-921) A 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)
The purpose of this study is to test the safety of the study drug, pembrolizumab, in combination with a chemotherapy plus a steroid. Some other reasons we are conducting this study is to see how well your body handles pembrolizumab compared to placebo (a look-alike with no active ingredients) in combination with a chemotherapy and a steroid, see how well pembrolizumab compared to placebo works in combination with a chemotherapy and a steroid and see if pembrolizumab helps patients live longer and have a better quality of life.
- Urinary System
- Cancer
- Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Multicenter
- Pembrolizumab (MK-3475)
Eligibility Criteria
- Patients must be 18 years of age or older Have confirmed adenocarcinoma of the prostate (cancer that develops in the gland cells of the prostate) Have prostate cancer progression while on androgen deprivation therapy (which is hormone therapy) (or post bilateral orchiectomy (removal of the testicles)) within 6 months prior to screening, as determined by the investigator Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by CT/MRI.
RESEARCH. INNOVATION. DISCOVERY.