drugset / Trial / NCT06529718
Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
Phase 2
Recruiting
72 enrolled
UNICANCER
Belgian Group of Digestive Oncology · collabCancer Research UK & UCL Cancer Trials Centre · collabSummit Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-10-09
- Primary completion
- 2027-08-03
- Completion
- 2029-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivonescimab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Comparator | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |