Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced… (NCT07437287) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers
France160 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Measurable tumor according to RECIST v1.1 classification
. Non-resectable or metastatic disease or recurrent after surgery (if recurrence more than 6 months after adjuvant treatment stop)
. Participants having received a standard first-line treatment (CISGEM + durvalumab or pembrolizumab) and eligible for second- or third-line treatment with FOLFOX. Participant could have received a previous targeted therapy in case of targetable alteration, but only one line of chemotherapy is permitted.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is combining mitazalimab with standard chemotherapy specifically for biliary tract cancers that have stopped responding to immunotherapy — does my cancer fit that profile, and would my previous treatment history make me a candidate worth discussing with you?
2Since this trial is Phase 2/3 and not yet recruiting, what does that mean for how much safety and effectiveness data already exists for mitazalimab in biliary tract cancer, and should I be thinking about other options in the meantime?
3The trial is measuring whether participants are still alive at 6 months as its main goal — what does that tell us about where researchers currently set the bar for this type of cancer, and how does that compare to what standard second-line treatments might offer me?
4Because the trial isn't recruiting yet, is there a way for you to monitor when it opens so we can revisit this option at the right time, or would starting a different treatment now potentially affect my eligibility later?
5Given that this trial targets immunotherapy-resistant disease specifically, if I haven't tried immunotherapy yet, should that be a step we consider first before looking at trials designed for patients who've already progressed through it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6 months overall survival rate of participants
Timeframe: From randomisation to 6 months after randomisation
. Adequate bone marrow reserve, normal renal and liver functions:
. No dihydropyrimidine dehydrogenase deficiency, as assessed by pre-treatment uracil blood level ≤ 16 ng/mL
Exclusion criteria
. Participants having received previous treatment with fluoropyrimidine, oxaliplatin or CD40 agonist, except for capecitabine given as adjuvant treatment (if last administered \> 6 months).
. Concurrent malignancy (other than BTC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 3 years or more and are deemed at negligible risk for recurrence, are eligible for the trial
. Known CNS metastases or carcinomatous meningitis
. History of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
. History of myocardial infarction within 12 months of the first administration of mitazalimab, uncontrolled angina pectoris, unstable cardiac arrhythmias, or congestive heart failure of New York Heart Association class II or greater
. QTc \>450 msec
. Known history of HIV, hepatitis B or active hepatitis C infection
. Toxicities from first-line treatment not resolved to Grade ≤ 1 (according to NCI-CTCAE v6.0) before randomization with the exception of alopecia