drugset / Trial / NCT07359456
Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to evaluate the superiority of ivonescimab combined with FOLFIRI over FOLFIRI + bevacizumab as second-line treatment of non resectable pMMR/MSS BRAFwt mCRC patients without liver metastases in terms of PFS. The main questions it aims to answer are: Does FOLFIRI + ivonescimab improve progression-free survival compared to FOLFIRI + bevacizumab? Participants will: Take FOLFIRI + ivonescimab or FOLFIRI + bevacizumab every 2 weeks for a maximum of 24 months Visit the clinic once every 2 weeks for checkups and tests, and have imaging done every 8 weeks Complete some quality of life questionnaires every 8 weeks
Timeline
- Start
- 2026-08-31
- Primary completion
- 2029-08
- Completion
- 2033-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Ivonescimab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |