Study on Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin for First-Line Treatment in Advanced Cholangiocarcinoma with IDH1 Mutation

Sponsor: Institut de Recherches Internationales Servier

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06501625

Provider View

This clinical trial is testing a new combination of drugs, including Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin, as the first treatment for patients with advanced cholangiocarcinoma that cannot be removed by surgery and has an IDH1 mutation.

Patient Parameters

Program Overview

The study aims to find out if a combination of Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin is safe and effective for treating advanced cholangiocarcinoma with an IDH1 mutation. Initially, the study will determine the best dose of the combination (Phase 1b) and then assess its effectiveness (Phase 2). Participants will have regular study visits during treatment, which includes cycles of 21 and 28 days. Follow-up visits will occur 30 and 90 days after treatment ends, and every 3 months thereafter to monitor survival. Visits may include blood tests, heart monitoring, and physical exams.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced cholangiocarcinoma that cannot be surgically removed and has an IDH1 mutation.
  • Have at least one tumor that can be measured by scans.
  • Have good bone marrow function, with specific levels of neutrophils, hemoglobin, and platelets.
  • Have good liver function, with bilirubin and liver enzymes within specified limits.
  • Have good kidney function, with creatinine clearance above 60 mL/min.

Exclusion Criteria

  • Have received certain treatments for advanced cholangiocarcinoma, except for one cycle of Durvalumab with Gemcitabine/Cisplatin.
  • Have had immune therapy or unresolved side effects from previous cancer treatments.
  • Have active autoimmune or inflammatory disorders, unless stable and not requiring systemic treatment.
  • Have a heart condition that affects the heart's electrical activity.
  • Have active infections like Hepatitis B, Hepatitis C, tuberculosis, or HIV, unless resolved or controlled.

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