MK3475-641

PRIMARY OBJECTIVES
-To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)
-To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide 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) 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 OBJECTIVES
-To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the time to initiation of the first subsequent anti-cancer therapy or death (TFST)
-To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the: Prostate-specific antigen (PSA)
response rate, PSA undetectable rate, Objective response rate (ORR) and duration of response (DOR) per PCWG-modified RECIST 1.1 as assessed by BICR
-To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the: Time to PSA progression, Time to radiographic soft tissue, progression per soft tissue rules of
PCWG-modified RECIST 1.1, as assessed by BICR, Time to pain progression (TTPP) based on Brief Pain Inventory-Short Form (BPI-SF) Item 3 “worst pain in 24 hours” and opiate analgesic use Analgesic Quantification Algorithm (AQA) score
-To evaluate the safety and tolerability of pembrolizumab plus enzalutamide versus placebo plus enzalutamide Prostate cancer represents the second most common malignancy diagnosed in men
worldwide, with an estimated annual incidence of over 1 million and an expected 300,000
plus deaths annually [Ferlay, J., et al 2015]. In the United States (US), approximately 1 in
every 9 men will be diagnosed with prostate cancer in his lifetime [Siegel, R. L., et al 2018]. 􀀀 Histoire médicale
􀀀 Poids et taille
􀀀 Examen physique
􀀀 Signes vitaux
􀀀 Électrocardiogramme
􀀀 Prises de sang
􀀀 Tomodensimétrie
􀀀 Analyse d’urine
􀀀 Questionnaires