Study of Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin for Patients with Advanced Cholangiocarcinoma with IDH1 Mutation

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What is this study about?

This clinical trial is focused on studying a type of cancer called cholangiocarcinoma, which affects the bile ducts. The trial specifically targets cases where the cancer is locally advanced, cannot be surgically removed, or has spread to other parts of the body, and where there is a specific genetic change known as an IDH1 mutation. The study is testing a combination of treatments to see how safe and effective they are when used together as a first-line therapy, meaning they are the first treatments given for this condition.

The treatments being tested include ivosidenib, a medication taken orally in the form of a film-coated tablet, and three other medications given through an infusion into a vein: durvalumab, gemcitabine, and cisplatin. The purpose of the study is to assess the safety and tolerability of these medications when used together, as well as to determine the best dose of ivosidenib to use in combination with the other drugs. The study will also look at how well this combination of treatments works in controlling the cancer.

Participants in the study will receive these treatments and be monitored for any side effects or changes in their condition. The study will be conducted in two phases: an initial phase to evaluate safety and determine the appropriate dose, followed by an expansion phase to further assess the effectiveness of the treatment combination. The trial aims to provide valuable information on the potential benefits of using these medications together for treating cholangiocarcinoma with an IDH1 mutation.

1 introduction to the trial

Upon joining the trial, the patient will be introduced to the study’s purpose and procedures. The trial aims to evaluate the safety and effectiveness of a combination of medications for treating a specific type of liver cancer known as cholangiocarcinoma with an IDH1 mutation.

2 medication administration

The patient will receive a combination of medications, including ivosidenib, durvalumab, gemcitabine, and cisplatin.

Ivosidenib is administered orally in the form of a 250 mg film-coated tablet.

Durvalumab, gemcitabine, and cisplatin are administered intravenously as solutions for infusion.

3 safety lead-in phase

During this phase, the focus is on assessing the safety and tolerability of the medication combination. The patient will be monitored for any side effects or adverse reactions.

The appropriate dosage of ivosidenib in combination with the other medications will be determined.

4 expansion phase

In this phase, the clinical activity of the medication combination will be evaluated. The patient’s response to the treatment will be assessed using specific criteria to measure tumor response.

The patient’s overall health and any changes in the condition will be closely monitored.

5 monitoring and evaluation

Throughout the trial, the patient will undergo regular assessments to monitor the effectiveness of the treatment and any potential side effects.

Blood tests and imaging studies may be conducted to evaluate the patient’s response to the treatment.

6 completion of the trial

The trial is expected to continue until January 15, 2030. Upon completion, the patient’s overall response to the treatment will be evaluated, and the results will contribute to understanding the effectiveness of the medication combination for this type of cancer.

Who Can Join the Study?

You must have a confirmed diagnosis of cholangiocarcinoma, which is a type of cancer that occurs in the bile ducts, and it must be either locally advanced, cannot be removed by surgery, or has spread to other parts of the body.
Your cancer must have a specific change in the IDH1 gene, which is a gene that can affect how cells grow.
You need to have at least one tumor that can be measured and evaluated according to specific guidelines used in cancer studies.
Your bone marrow, which is the soft tissue inside your bones that makes blood cells, must be working well. This means having enough white blood cells, red blood cells, and platelets.
Your liver function must be adequate. This means your liver should be working well enough, with certain blood tests showing normal or near-normal levels, unless you have a specific condition called Gilbert’s syndrome.
Your kidney function must be adequate. This means your kidneys should be able to filter waste from your blood at a certain rate, which can be measured by a test called creatinine clearance.
You must be within the age range of 18 to 64 years old or 65 years and older.
Both men and women can participate in the study.

Who Cannot Join the Study?

Patients who do not have a specific type of cancer called cholangiocarcinoma with an IDH1 mutation cannot participate. Cholangiocarcinoma is a cancer that forms in the bile ducts, and an IDH1 mutation is a change in a specific gene that can affect cancer growth.
Patients who have had previous treatments for their cancer may not be eligible.
Patients with other serious health conditions that could interfere with the study treatment may be excluded.
Patients who are unable to follow the study procedures or attend required visits may not be able to participate.
Patients who are pregnant or breastfeeding are not allowed to join the study.
Patients who have allergies or reactions to the study drugs or similar medications may be excluded.
Patients who are participating in another clinical trial at the same time may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Uyfhtnbicyxtytuwmhmlp Dvcqpypaton Ayr	Duesseldorf	Germany
Hbgesire Vjut dhzbvvhn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2025
Germany	Recruiting	01.03.2025
Spain	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Ivosidenib is a medication being studied for its potential to treat cholangiocarcinoma, a type of cancer that affects the bile ducts. It is specifically being tested in patients whose cancer has a mutation in the IDH1 gene. This medication is part of a combination therapy aimed at improving treatment outcomes for patients with advanced stages of this cancer.

Durvalumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used in combination with other medications to enhance the body’s natural defenses against cancer, particularly in cases where the cancer is advanced and cannot be surgically removed.

Gemcitabine is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is commonly used to treat various types of cancer, including cholangiocarcinoma, and is part of the combination therapy being tested in this trial.

Cisplatin is another chemotherapy medication that damages the DNA of cancer cells, leading to their death. It is often used in combination with other drugs to treat different cancers, including those that are difficult to remove surgically. In this trial, it is combined with other therapies to assess its effectiveness in treating advanced cholangiocarcinoma.

Investigated diseases:

Cholangiocarcinoma

Cholangiocarcinoma with an IDH1 Mutation – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. When it is described as locally advanced, unresectable, or metastatic, it means the cancer has spread beyond its original location and cannot be removed by surgery. An IDH1 mutation in this context refers to a specific genetic change in the cancer cells that can affect their growth. This mutation can lead to the production of abnormal proteins that may contribute to the cancer’s progression. The disease can cause symptoms such as jaundice, abdominal pain, and weight loss as it progresses. The presence of the IDH1 mutation can influence the approach to treatment and management of the disease.

Trial ID:

2024-514261-19-00

Protocol code:

S095031-210

NCT ID:

NCT06501625

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin for Patients with Advanced Cholangiocarcinoma with IDH1 Mutation

What is this study about?

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