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Study of ivosidenib maintenance treatment in patients with IDH1-mutated cholangiocarcinoma after standard chemotherapy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with intrahepatic cholangiocarcinoma, a type of bile duct cancer that occurs inside the liver, specifically in patients whose cancer has a particular genetic change called IDH1 mutation. The study examines the effectiveness of a medication called ivosidenib (Tibsovo) given as maintenance therapy after standard chemotherapy treatment in patients whose cancer has been completely removed through surgery.

The purpose of this research is to determine if taking ivosidenib tablets can help prevent or delay the cancer from returning after initial treatment. The medication is given in the form of film-coated tablets that are taken by mouth. Patients who participate will receive the study medication for up to 12 months after completing their standard chemotherapy treatment.

During the study, patients will need to take the medication daily and attend regular medical check-ups. The treatment involves taking ivosidenib tablets at a daily dose that will not exceed 500 milligrams. Doctors will monitor patients' health through various medical examinations and imaging tests to check if the cancer returns and to watch for any side effects of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    After completing standard chemotherapy treatment, you will undergo imaging tests to confirm you are tumor-free. These tests must be done within 6 weeks before starting the trial.

    Your doctor will review your blood tests to check your liver, kidney, and blood cell counts to ensure they are at appropriate levels.

  2. Step 2

    Starting medication

    You will receive Tibsovo tablets (250 mg) to take by mouth.

    This medication contains the active substance ivosidenib.

    If you are taking blood thinners like warfarin or Phenprocoumon, your doctor will switch you to a different type of blood thinner before starting the trial medication.

  3. Step 3

    Regular monitoring

    Your health status will be monitored through scheduled medical visits and examinations.

    You will complete quality of life questionnaires during the trial.

    Blood samples will be collected for analysis.

    If your disease returns, your doctor may request additional tissue samples if it is safe to do so.

  4. Step 4

    Safety measures

    You must use effective birth control during the treatment and for 6 months after the last dose if you or your partner can become pregnant.

    Female participants must have a negative pregnancy test within 7 days before starting the treatment.

  5. Step 5

    Follow-up period

    Your health will be monitored for at least one year to track your recovery and any possible return of the disease.

    The study will continue monitoring your overall survival throughout the trial period.

Who can join the trial?

12 criteria

  • Must be at least 18 years old at the time of giving consent
  • Must provide signed informed consent
  • Must be willing to provide: - Blood samples for testing - Previous tumor tissue samples (if available) - New tumor samples if disease returns (if safe to obtain)
  • Must agree to use effective birth control methods: - Women who can become pregnant - Men with partners who can become pregnant - Must continue for 6 months after last treatment - Women must have negative pregnancy test within 7 days before starting treatment
  • Must have surgically removed intrahepatic cholangiocarcinoma (bile duct cancer within the liver) with complete tumor removal and no spread to other parts of body
  • Must have confirmed IDH1 mutation (a specific genetic change) in tumor tissue
  • Must have completed standard chemotherapy treatment before joining the study
  • Must have medical imaging (taken within 6 weeks) showing no signs of cancer
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must have acceptable blood, liver, and kidney function tests
  • Must have normal blood clotting function. Patients on blood thinners like warfarin must switch to alternative medication
  • Must be willing to follow study requirements, including: - Taking medications as prescribed - Attending all scheduled appointments - Following up as required

Who cannot join the trial?

12 criteria

  • Previous treatment with ivosidenib or any other IDH1 inhibitor (medications that target a specific enzyme mutation)
  • Active or uncontrolled serious infections requiring treatment
  • History of another cancer within the past 3 years, except for adequately treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart conditions, including:
    • Unstable heart rhythm problems
    • Heart failure requiring treatment
    • Heart attack within the past 6 months
    • Severe liver problems not related to the primary disease
    • Pregnancy or breastfeeding
    • Unable to swallow oral medications
    • Any condition that would make it unsafe to participate in the study, as determined by the study doctor
    • Mental health conditions that could interfere with following study procedures
    • Current participation in other clinical trials
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Investigated drugs

Ivosidenib is a medication used to treat certain types of bile duct cancer (cholangiocarcinoma) that have a specific genetic mutation called mIDH1. It works by blocking an abnormal form of an enzyme that can cause cancer cells to grow. This medication is given as a maintenance therapy, which means it's used after standard chemotherapy to help maintain the treatment response and prevent the cancer from returning. Standard of care (SOC) chemotherapy refers to the established, conventional cancer treatment that patients receive initially after surgery. This is the standard treatment that has been proven effective and is commonly used before starting the maintenance therapy with ivosidenib.

What is already known about the treatment

Ivosidenib - An oral targeted therapy medication that works by inhibiting mutant IDH1 (isocitrate dehydrogenase-1) enzyme in cancer cells, specifically developed for treating cholangiocarcinoma (bile duct cancer) with IDH1 mutations. The drug is administered in tablet form and is being studied as a maintenance therapy following standard chemotherapy in patients who have undergone curative treatment for cholangiocarcinoma. It belongs to the class of targeted cancer therapies known as IDH inhibitors, and works by blocking the abnormal enzyme production that contributes to cancer cell growth, potentially helping to prevent cancer recurrence after initial treatment.

Investigated diseases

Cholangiocarcinoma – A cancer that forms in the bile ducts, which are tubes that connect the liver to the gallbladder and small intestine. It starts in the cells that line the bile ducts, either inside or outside the liver. The disease typically develops when healthy cells in the bile ducts undergo changes in their DNA, causing the cells to grow uncontrollably and form a mass. This condition can affect both the small bile ducts within the liver (intrahepatic) and the larger ducts outside the liver (extrahepatic). The disease can progress by spreading along the bile ducts and potentially to nearby lymph nodes and other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-520219-42-00Protocol codeadIVOEstimated enrolment40 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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