Study of MP0317 with durvalumab, gemcitabine and cisplatin combination therapy as first-line treatment for patients with advanced biliary tract cancer

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What is this study about?

This clinical trial focuses on treating patients with Advanced Biliary Tract Carcinoma, a type of cancer that affects the bile ducts. The study evaluates a new treatment approach combining several medications: MP0317 (an experimental drug), durvalumab (an immunotherapy medication), and two chemotherapy drugs – gemcitabine and cisplatin.

The purpose of this study is to determine how well this combination therapy works in patients who have not previously received treatment for their advanced bile duct cancer. The treatment involves giving the medications through intravenous infusions, which means they are delivered directly into the bloodstream through a vein.

During the study, patients will receive treatment over several months. The doctors will monitor how the cancer responds to the treatment using imaging scans. They will also track any side effects that may occur and evaluate how the treatment affects patients’ quality of life. The study will measure how long patients live without their cancer getting worse and their overall survival time.

1 Initial treatment cycle begins

The treatment consists of four medications administered through intravenous infusion: gemcitabine, durvalumab, cisplatin, and MP0317

Treatment will be provided to patients with advanced biliary tract carcinoma (cancer of the bile ducts)

2 Regular monitoring and assessments

Regular medical examinations will be conducted to monitor the response to treatment

Doctors will assess the condition using RECIST criteria (a standardized way to measure if tumors are responding to treatment)

Blood samples will be collected to monitor treatment effectiveness

Quality of life assessments will be conducted using specialized questionnaires (EORTC-QLQ-C30 and EORTC QLQ-BIL21)

3 Ongoing treatment and evaluation

Treatment will continue while monitoring for any side effects

Side effects will be assessed using standardized criteria

Regular imaging scans will be performed to evaluate tumor response

Blood tests will check for antibodies and medication levels in the body

4 12-month assessment

A major evaluation will occur at the 12-month mark to assess if the disease has progressed

Doctors will determine the effectiveness of the treatment based on tumor measurements

The assessment will include evaluation of overall health status and quality of life

5 Long-term follow-up

Continued monitoring until November 2028 (estimated study end date)

Regular assessments of survival and disease status

Ongoing evaluation of long-term treatment effects

Who Can Join the Study?

Must sign and date an informed consent form
Must complete hepatitis B and C screening tests
Must be covered by French social security system
Must be able to follow study requirements as determined by the doctor
Must have confirmed biliary tract cancer (cancer in the bile ducts inside or outside the liver, excluding gallbladder cancer)
Must have advanced cancer that has spread or cannot be surgically removed
Must not have received previous cancer treatments (except Capecitabine treatment that ended at least 6 months ago)
Must be at least 18 years old
Must have cancer that can be measured using special imaging techniques
If previously received radiation therapy, must have recovered from side effects to mild or no symptoms
Must have good physical function ability (ECOG performance score less than 2, meaning able to carry out most daily activities)
Female participants must either:
- Use effective birth control and have a negative pregnancy test before starting treatment, or
- Be unable to become pregnant

Who Cannot Join the Study?

Prior treatment with systemic anti-cancer therapy for advanced biliary tract cancer
Known brain metastases (spread of cancer to the brain) that are untreated or unstable
Active or prior autoimmune disease (condition where immune system attacks healthy cells) within the past 2 years
History of other cancers within 3 years before starting the study, except for successfully treated non-melanoma skin cancer or cervical cancer
Significant heart problems including uncontrolled high blood pressure, heart attack within 6 months, or irregular heartbeat
Active or chronic hepatitis B or C (liver infections)
Active tuberculosis (TB) infection
Pregnant or breastfeeding women
Known allergic reactions to the study medications or their components
Participation in another clinical trial within 4 weeks before starting this study
Major surgery within 4 weeks before starting the study
Any condition that, in the opinion of the study doctor, would make it unsafe to participate in the trial

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Regional Universitaire	Besançon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ciompi Lnlv Bcbxrb	Lyon	France
Csljae Hawavxapvpl Rmjkvwrh Umhxxzcjaigve Dv Thjvl	Tours	France
Imbthlir Chxpx	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2025

Trial locations

Investigated drugs:

Based on the trial information provided, the medications involved are:

MP0317 is a novel targeted therapy designed to activate CD40 receptors specifically in tumor areas where FAP (Fibroblast Activation Protein) is present. It’s a DARPin molecule that aims to stimulate the immune system’s response against cancer cells while minimizing side effects in healthy tissues.

Durvalumab is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein called PD-L1, which can help the immune system recognize and attack cancer cells more effectively.

Gemcitabine is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell growth and division, helping to stop or slow the spread of cancer cells.

Cisplatin is a platinum-based chemotherapy medication that damages the DNA of cancer cells, preventing them from dividing and growing. It’s commonly used in combination with other cancer treatments to increase their effectiveness.

Investigated diseases:

Biliary neoplasm

Biliary Tract Carcinoma – A cancer that develops in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine. The disease begins in the cells that line these ducts and can occur in any part of the biliary system. As the cancer grows, it can block the bile ducts and spread to nearby organs. The condition typically develops gradually, with the tumor growing and potentially spreading to other parts of the biliary system. Advanced biliary tract carcinoma refers to the stage where the cancer has grown beyond its original location.

Trial ID:

2024-520029-35-01

Protocol code:

2024/926

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of MP0317 with durvalumab, gemcitabine and cisplatin combination therapy as first-line treatment for patients with advanced biliary tract cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?