NCT06529718

Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1/VEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced/Metastatic Biliary Cancers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment. Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Detailed description

This is a Phase 2, multicentre, randomised, two-arm, open-label trial to evaluate whether ivonescimab is superior to standard second-line chemotherapy in the treatment of patients with advanced biliary tract cancer. The trial will be open to patients who participated in the screening phase of the SAFIR-ABC10 protocol (NCT05615818) and who experienced disease progression on or following the first-line standard of care (CISGEM regimen). A total of 72 patients will be enrolled and randomly assigned (2:1) to receive treatment with either: * Experimental arm: Ivonescimab 20 mg/kg by intravenous infusion (IV) once every 3 weeks (Q3W). * Control arm: Standard second-line chemotherapy - FOLFOX regimen Response to treatment will be assessed according to RECIST v1.1 by radiographic exams performed every 42 (±7) days. Patients will continue treatment until disease progression or for a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	20 mg/kg IV infusion every 3 weeks
DRUG	FOLFOX regimen	oxaliplatin 85 mg/m² IV, leucovorin 200 mg/m² IV (or folinic acid 400 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46 hour continuous IV infusion, every 2 weeks

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-08-03
• Completion: 2029-01-30
• First posted: 2024-07-31
• Last updated: 2025-11-17

Locations

3 sites across 2 countries: France, United Kingdom