Clinical Trials Search
Clinical Trial 20070
Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03834493
Phase: Phase III
Prinicipal Investigator: Julie Kish
Study Title
A 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)
Summary
The purpose of this study is to test the safety of the study drugs, pembrolizumab in combination with a hormone drug (enzalutamide) for prostate cancer,
Objective
Primary: To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to OS Hypothesis (H1): The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to OS To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to rPFS per PCWG-modified RECIST 1.1 as assessed by BICR where soft-tissue will be assessed per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ and bone disease will be assessed per PCWG criteria Secondary: To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to TFST To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the: PSA response rate PSA undetectable rate { ORR and DOR per PCWGmodified RECIST 1.1 as assessed by BICR
Therapies
Medications
Enzalutamide (Xtandi); Pembrolizumab (Keytruda); Placebo ()
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