進行性/転移性固形腫瘍患者を対象としたゲバサクストゥレブ(V937)とペムブロリズマブ(MK-3475)の併用療法に関する研究(V937-013)
基本情報
- NCT ID
- NCT04521621
- ステータス
- 中止
- 試験のフェーズ
- 第1/第2相
- 試験タイプ
- 介入
- 目標被験者数
- 76
- 治験依頼者名
- Merck Sharp & Dohme LLC
概要
The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.
対象疾患
介入
依頼者(Sponsor)
実施施設 (2)
医療法人社団イースト会 新宿東口イースト駅前クリニック
Kashiwa, Chiba, Japan
国立研究開発法人国立がん研究センター中央病院
Kashiwa, Chiba, Japan