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 range18 Years
SexALL
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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
✓. 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
What they're measuring
1
6 months overall survival rate of participants
Timeframe: From randomisation to 6 months after randomisation
✕. 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