Ivosidenib, Durvalumab, and Chemotherapy for IDH1-Mutated Cholangiocarcinoma
This study is testing a new combination of medicines for people with locally advanced or metastatic cholangiocarcinoma (bile duct cancer) that has an IDH1 gene mutation. The medicines being studied are ivosidenib, durvalumab, and chemotherapy (gemcitabine and cisplatin). Researchers want to see how safe this combination is and if it can shrink tumors. To join, you must have this specific type of cholangiocarcinoma with an IDH1 mutation and at least one measurable tumor. The study will first look at safety and then expand to see how well the treatment works. The goal is to see how many people respond to the treatment. This study plans to enroll 52 participants.
- Study design
- This is an interventional study that will first determine a safe dose combination (Phase 1b) and then assess the treatment's activity (Phase 2). It plans to enroll 52 participants.
- What's involved
- During treatment, you will have study visits on days 1, 8, and 15 of Cycle 1, on days 1 and 8 of Cycles 2 to 8, and on day 1 of each additional cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored for approximately 90 days after the end of treatment. The study will assess objective response rate until the end of the study, which is approximately 5 years.
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NCT06501625
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Recruiting
PHASE1Ages 18+InterventionalTreatmentInstitut de Recherches Internationales ServierInvestigator-initiated
~52 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:IvosidenibDurvalumab (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)
At a glance
Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs)
Measured over Through Cycle 1 (Cycle 1 is 21 days)
+2 more outcomes measured
Conditions
Where it's being run
38 sites across 16 statesSouth Korea7
Germany5
Spain5
Brazil4
France3
Japan3
California2
Illinois1
Who to contact
Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Have a histopathological confirmed diagnosis consistent with locally advanced unresectable or metastatic cholangiocarcinoma.
Have documented IDH1 gene-mutated cholangiocarcinoma based on local or central laboratory testing (R132C/L/G/H/S mutation variants tested).
Have at least one evaluable and measurable lesion as defined by RECIST v1.1.
Have adequate bone marrow function as evidenced by:
Absolute neutrophil count ≥ 1,500/mm3 or 1.5 ×109/L
Hemoglobin ≥ 9 g/dL
Platelet count ≥ 100,000/mm3 or 100 × 109/L
Have adequate hepatic function as evidenced by:
Serum bilirubin ≤ 2.0 × the upper limit of normal (ULN); this will not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before randomization
Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5.0 × ULN
Have adequate renal function, defined as: creatinine clearance \> 60 mL/min per 24 hour urine or as calculated on the Cockcroft-Gault formula (using actual body weight):
Patients with Grade ≥2 neuropathy to be evaluated on a case-by-case basis after consultation with the medical monitor
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ivosidenib may be included only after consultation with the medical monitor
Participation in another interventional study at the same time or within 14 days prior to the first study medication (triple combination treatment) administration. For patients having participated to another prior interventional study, the first dose of ivosidenib should occur after a period greater than or equal to 5 half-lives or 28 days, whichever is shorter of the last dose of the prior investigational product.
Active or prior documented autoimmune or inflammatory disorders including:
inflammatory bowel disease (e.g., colitis or Crohn's disease)
diverticulitis (with the exception of diverticulosis)
systemic lupus erythematosus
Sarcoidosis syndrome
Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.)
chronic skin condition that does not require systemic therapy
vitiligo
alopecia
hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy
unmedicated celiac disease that is controlled by diet
Have heart rate-corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome/sudden death, polymorphic ventricular arrhythmia). The Sponsor should review participants with bundle branch block and prolonged QTcF for potential inclusion.
Have an active infection, including:
Hepatitis B (clinical evaluation includes: presence of hepatitis B surface antigen \[HBsAg\] and/or anti-HBcAb with detectable hepatitis B virus \[HBV\] DNA ≥ 10 IU/mL)
Hepatitis C
Tuberculosis (clinical evaluation includes: clinical history, physical examination and/or radiographic findings, and tuberculosis testing as per local practice)
Human immunodeficiency virus (clinical evaluation includes: positive HIV 1/2 antibodies) Note: Patients with a resolved or past HBV infection (i.e., presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) do not need to be excluded from the study. Patients positive for hepatitis C (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
Exclusion
Received treatment for locally advanced, unresectable or metastatic disease with the following exceptions:
Treatment with up to one cycle of durvalumab plus gemcitabine/cisplatin treatment is permitted before study participation. Note: For the Safety Lead-In Phase, participants who received one prior cycle of durvalumab plus gemcitabine/cisplatin and required dose modifications for treatment-related toxicity are excluded.
Patients who developed recurrent disease \> 6 months after surgery with curative intent, and, if given, \> 6 months after the completion of adjuvant (chemotherapy and/or radiation).
Prior exposure to immune-mediated therapy, including, but not limited to, anti-PD-1or other anti-PD-L1, and anti-PD-L2, anti-CTLA-4 antibodies, excluding therapeutic anticancer vaccines.
What this trial measures
- Safety Lead-in Phase: Number of Dose-limiting toxicities (DLTs)Through Cycle 1 (Cycle 1 is 21 days)
- Safety Lead-in Phase: Number of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)Through 90 days after the end of treatment (Approximately 5 years)
- Expansion Phase: Objective response rate (ORR)Through the end of the study (Approximately 5 years)
Confirmed complete response (CR) or confirmed partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1