転移性去勢抵抗性前立腺癌（mCRPC）におけるペムブロリズマブ（MK-3475）とオラパリブの併用とアビラテロン酢酸塩またはエンザルタミドの併用を比較する試験（MK-7339-010/KEYLYNK-010）

基本情報

NCT ID

NCT03834519

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

793

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per standard of care (SOC) schedule. In addition, electronic patient-reported outcome (ePRO) assessments will no longer be performed and biomarker samples will no longer be collected.

対象疾患

介入

依頼者（Sponsor）

実施施設 (25)