再発性婦人科明細胞癌におけるドスタルリマブ単独またはベバシズマブ併用と非プラチナ製剤化学療法を比較する3群ランダム化第II相試験：DOVE（APGOT-OV7/ENGOT-ov80試験）

基本情報

NCT ID

NCT06023862

ステータス

募集中

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

198

治験依頼者名

Yonsei University

概要

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. 1. Group A: Dostarlimab monotherapy * First 3 cycles: Dostalimab 500mg every 3 weeks, IV * 4 cycles \~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV 2. Group B: Dostarlimab + Bevacizumab combination therapy * First 3 cycles: Dostalimab 500mg every 3 weeks, IV * 4 cycles \~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV * Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity 3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

対象疾患

介入

依頼者（Sponsor）

実施施設 (10)