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

Conditions

• Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ivosidenib — DRUG
  Two 250 mg tablets, totaling 500 mg, administered orally once daily, taken continuously throughout treatment duration
• Durvalumab (for the first 8, 21-day, cycles) — DRUG
  1500mg intravenous (IV) infusion every 3 weeks, for a maximum of 8 (21-day) cycles
• Gemcitabine (for the first 8, 21-day, cycles) — DRUG
  1000 mg/m2 IV infusion on days 1 and 8 of every 21-day cycle, for a maximum of 8 cycles
• Cisplatin (for the first 8, 21-day, cycles) — DRUG
  25 mg/m\^2 IV infusion on days 1 and 8 of every 21-day cycle, for a maximum of 8 cycles
• Durvalumab (starting from cycle 9) — DRUG
  1500mg intravenous (IV) infusion every 4 weeks, starting from cycle 9. Cycles are 28 days long, starting Cycle 9.
• Ivosidenib Recommended Combination Dose (RCD) — DRUG
  RCD administered orally once daily, taken continuously throughout treatment duration

Study Details

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.

Key Dates

Start date

Dec 16, 2024

Status verified

May 2026

Primary completion

Jul 23, 2026

Completion

Sep 13, 2027

Study Design

Enrollment

52 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead-In Phase
• Experimental: Expansion Phase

Primary Outcome Measure

Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs) [ Time Frame: Through Cycle 1 (Cycle 1 is 21 days) ]

Central Contacts

• Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department
  +33 1 55 72 60 00
  [email protected]

Locations (8)

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