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) (KEYNOTE-921)
The purpose of the study is to compare any good and bad effects of the study drug called pembrolizumab (MK-3475) plus chemotherapy plus steroid to be better, the same, or worse than the usual approach in treating metastatic castration-resistant prostate cancer (mCRPC). Pembrolizumab has been approved by the FDA, is available by prescription to treat several different cancers, but may not for prostate cancer.
Chemotherapy-naïve metastatic castration resistant prostate cancer
Pembrolizumab versus placebo plus docetaxel with prednisone
- Metastatic prostate cancer patient who may previously be treated with next-generation AR-targeted therapy abiraterone acetate or enzalutamide without prior chemotherapy treatment for mCRPC
- Subjects' prostate cancer progressed despite previous androgen deprivation therapy or anti-androgen therapies.
- Subject must supply a newly biopsied tumor tissue or have a tumor tissue previously collected from a previous procedure.
- Subjects have not had an active autoimmune disease that has required systemic treatment in past 2 years.
- Subjects have not had a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent)
18 - NA
Healthy Volunteers Needed
Duration of Participation
Up to 24 months
Clinical Trials Information Line: Phone 503-494-1080 or firstname.lastname@example.org
Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.)