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New hope for rare bile duct cancer: targeted combo trial launches

NCT ID NCT06501625

Disease control Sponsor: Institut de Recherches Internationales Servier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new combination of drugs (ivosidenib, durvalumab, and chemotherapy) as a first treatment for people with advanced bile duct cancer that has a specific genetic change called an IDH1 mutation. The goal is to see if the combination is safe and works better than standard care. About 52 adults with inoperable or spread cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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): Creatine CL (mL/min)= (140 - Age) × (weight in kg) × (0.85 if female)/72 × serum creatinine (mg/dL) Exclusion Criteria: * 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. * Unresolved Grade ≥2 adverse events from a previous anticancer therapy, with the exception of alopecia and vitiligo and the laboratory values listed in the inclusion criteria. * 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.) Note: in cases with no active disease for ≥ 5 years, patients may be considered for inclusion if approved by the Medical Monitor. Participants with the following conditions are eligible for the study: * 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.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    38 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alfred Health

    RECRUITING

    Melbourne, 3004, Australia

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • CIONC

    RECRUITING

    Curitiba, 80810050, Brazil

  • Cancer and Blood Speciality Clinic - Los Alamitos

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Cha Bundang Medical Center

    RECRUITING

    Seongnam, 13496, South Korea

  • Charite Universitatsmedizin

    RECRUITING

    Berlin, 13353, Germany

  • Chu Montpellier-Hopital Saint-Eloi

    RECRUITING

    Montpellier, 34295, France

  • Duke University

    RECRUITING

    Durham, North Carolina, 27708, United States

  • Gibbs Cancer Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • H. 12 de Octubre

    RECRUITING

    Madrid, 28040, Spain

  • H. Valle de Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Hospital de Amor - Barretos

    RECRUITING

    Barretos, 14784400, Brazil

  • Hôpital Beaujon

    RECRUITING

    Clichy, 92210, France

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Instituto Dor de Pesquisa E Ensino Sp

    RECRUITING

    São Paulo, 4543000, Brazil

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, 241-8515, Japan

  • Kyoto University Hospital

    RECRUITING

    Kyoto, 606-8507, Japan

  • Medizinische Hochschule Hannover Oe 6810

    RECRUITING

    Hanover, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Northwestern Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oncoclinicas Mg

    RECRUITING

    Belo Horizonte, 303600680, Brazil

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, M5G 2C4, Canada

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 3080, South Korea

  • Seoul St. Mary'S Hospital

    RECRUITING

    Seoul, 6591, South Korea

  • Severance

    RECRUITING

    Seoul, 3722, South Korea

  • Tennesse Oncology - Elliston Place Plaza

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitären Centrums Für Tumorerkrankungen (Uct) Der J.W. Goethe-Universität Frankfurt

    RECRUITING

    Frankfurt, 60488, Germany

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Usc Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States