BRCA遺伝子変異非陽性進行上皮性卵巣がん（EOC）の女性患者に対する第一選択治療として、ペムブロリズマブ（MK-3475）による化学療法とそれに続くオラパリブ（MK-7339）による維持療法を検討する試験（MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036）

基本情報

NCT ID

NCT03740165

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,367

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 treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1 positive tumors (CPS≥10) and in all participants.

対象疾患

介入

依頼者（Sponsor）

実施施設 (15)