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Countering Immunotherapy Resistance With Novel Combinations in Advanced Biliary Tract Cancers
The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab. The main questions it aims to answer are: * Does the addition of Mitazalimab enhance efficacy? * What medical problems do participants have when taking Mitazalimab + mFOLFOX? Participants will: * Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle. * Visit the clinic once every 2 weeks for checkups and tests * Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.
Multicenter, open-label, randomized phase II/III trial evaluating the efficacity of mitazalimab in combination with mFOLFOX compared to mFOLFOX alone in participant advanced BTC
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, France
CHU de Bordeaux - Hopital Haut Leveque
Bordeaux, France
CHU Brest
Brest, France
Centre François Baclesse
Caen, France
CHU Estaing
Clermont-Ferrand, France
CHU de Dijon
Dijon, France
CHU Grenoble Alpes
Grenoble, France
CHU Lille
Lille, France
Centre Léon Bérard
Lyon, France
CHU de Lyon
Lyon, France
Start Date
July 1, 2026
Primary Completion Date
April 1, 2030
Completion Date
October 1, 2031
Last Updated
February 27, 2026
160
ESTIMATED participants
mFOLFOX regimen
DRUG
Mitazalimab
DRUG
Lead Sponsor
UNICANCER
Collaborators
NCT04900818
NCT07466238
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07454486