NCT07437287

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

Countering Immunotherapy Resistance With Novel Combinations in Advanced Biliary Tract Cancers

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Biliary Tract Cancer (BTC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-07-01
• Primary completion: 2030-04-01
• Completion: 2031-10-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

22 sites across 1 country: France