Phase 1/2Active, not recruiting
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open Label, Multicenter Trial Investigating 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
- Sponsor
- Institut de Recherches Internationales Servier (Academic or other)
- Enrolment
- 55 enrolled
- Conditions
- Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- Interventions
- Ivosidenib; Durvalumab (for the first 8, 21-day, cycles); Gemcitabine (for the first 8, 21-day, cycles); Cisplatin (for the first 8, 21-day, cycles); Durvalumab (starting from cycle 9); Ivosidenib Recommended Combination Dose (RCD)
- Ages
- adults, older adults
- Registry
- NCT06501625, CTIS2024-514261-19-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs)
- Safety Lead-in Phase: Number of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
- Expansion Phase: Objective response rate (ORR)
History
Primary completion expected
Last registry update
Started
Registered