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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-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921)
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).
Primary Objectives: To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival. - To compare pembrolizumab plus docetaxel plus prednisone 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 (BICR). Secondary Objective: - To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to time to initiation of the first subsequent anti-cancer therapy or death (TFST) - To evaluate pembrolizumab plus docetaxel plus prednisone versus placebo plus docetaxel plus prednisone with respect to PSA response rate Objective response rate (ORR) and the duration of response (DOR) per PCWG-modified RECIST 1.1 as assessed by BICR
Dexamethasone (); Pembrolizumab (Keytruda); Placebo (); Taxotere (docetaxel); docetaxel (); prednisone ()
> Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
> Has a known additional malignancy that is progressing or has required active treatment in the last 3 years