プラチナ製剤耐性再発卵巣癌に対するペムブロリズマブ/プラセボ+パクリタキセル+ベバシズマブ併用または非併用療法（MK-3475-B96/KEYNOTE-B96/ENGOT-ov65）

基本情報

NCT ID

NCT05116189

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

643

治験依頼者名

Merck Sharp & Dohme LLC

概要

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

対象疾患

介入

依頼者（Sponsor）

実施施設 (12)