トリプルネガティブ乳がん（TNBC）における第一選択化学療法＋ペムブロリズマブによる導入療法後のオラパリブ＋ペムブロリズマブと化学療法＋ペムブロリズマブの併用療法を比較する試験（MK-7339-009/KEYLYNK-009）

基本情報

NCT ID

NCT04191135

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

462

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)