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Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 11, 2026 (before its estimated July 23, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 37 to 38v10
  2. Study sites: 33 to 37v9
  3. Study sites: 28 to 33v8
  4. Study sites: 27 to 28v7
  5. Study sites: 24 to 27v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 15 to 24v5
  2. Study sites: 17 to 15v4
  3. Trial status: Active, Not Recruiting to Recruiting Study sites: 2 to 17 · Primary completion date: Sep 15, 2026 to Jul 23, 2026 · Completion date: Jan 15, 2030 to Sep 13, 2027v3 Show 3 more changesShow less
    • Study sites: 2 to 17
    • Primary completion date: Sep 15, 2026 to Jul 23, 2026
    • Completion date: Jan 15, 2030 to Sep 13, 2027
  4. Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06501625
Lead Sponsor Institut de Recherches Internationales Servier
Conditions Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov