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Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers

NCT07437287 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Biliary Tract Cancer (BTC)

Interventions

DRUG

mFOLFOX regimen

oxaliplatin 85 mg/m² intravenous infusion (IV), folinic acid 400 mg/m² IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46-hours continuous IV infusion: * every two week (14-day cycles) until disease progression on control arm * at D8 the first cycle and at D1 for subsequent cycles (14-day cycles) until disease progression on experimental arm

DRUG

Mitazalimab

The first cycle of treatment (21-day cycle): Mitazalimab 900 µg/kg by intravenous infusion (IV) at D1 and D10 Subsequent cycles (14-day cycles): Mitazalimab 900 µg/kg by intravenous infusion (IV) at D3 of each cycle until disease progression

Sponsors & Collaborators

  • Alligator Bioscience AB

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Cindy NEUZILLET · Institut Curie

  • Matthieu DELAYE · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-04-30
Completion
2031-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07437287 on ClinicalTrials.gov