IDH1変異を有する局所進行性または転移性胆管癌患者における第一選択療法としてのイボシデニブ＋デュルバルマブ＋ゲムシタビン／シスプラチン

基本情報

NCT ID

NCT06501625

ステータス

募集中

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

52

治験依頼者名

Servier

概要

The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The study will begin with a safety lead-in phase (Phase 1b study) to determine the recommended combination dose (RDC) and then will transition to an expansion phase (Phase 2 study) to assess the clinical activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin at the RCD. During the treatment period participants will have study visits on days 1, 8, and 15 of Cycle 1, on days 1 and 8 of Cycle 2 to 8, and on day 1 of each additional cycle. Cycles 1 through 8 are 21 day cycles, and each following cycle is 28 days. Approximately 30 days and 90 days after treatment has ended, safety follow-up visits will occur and then participants will be followed for survival every 3 months. Study visits may include blood tests, ECG, vital signs, and a physical examination.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)