Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

第3相完了 NCT03834493

対象疾患	Prostatic Neoplasms
相	第3相
スポンサー	Merck Sharp & Dohme LLC
ステータス	完了
参加者数	1,244 名
介入（薬剤）	Pembrolizumab, Enzalutamide
開始日	2019年7月28日
完了日	2022年12月12日
結果公開日	2023年12月20日

概要

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to 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.

Overall Survival (OS)

Up to 40 months (through database cut-off date of 12-Dec-2022) · Months

Pembrolizumab + Enzalutamide	24.7 Months
Placebo + Enzalutamide	27.3 Months

p-value	0.6621
Hazard Ratio (HR)	1.04 (95% CI 0.88–1.22)

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

Up to 40 months (through database cut-off date of 12-Dec-2022) · Months

Pembrolizumab + Enzalutamide	10.4 Months
Placebo + Enzalutamide	9.0 Months

p-value	0.4073
Hazard Ratio (HR)	0.98 (95% CI 0.84–1.14)

BENITIONS で見る ClinicalTrials.gov の原文を見る

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すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。

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