NCT07359456

Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases

Randomized Phase 2 Study of Second-line Chemotherapy Comparing FOLFIRI + Ivonescimab Versus FOLFIRI + Bevacizumab in Microsatellite Stable (MSS)/ Proficient MisMatch Repair (pMMR) BRAF Wild Type (BRAFwt) Advanced Colorectal Cancer (mCRC) Without Liver Metastases

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	Ivonescimab 20 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W)
DRUG	Bevacizumab	Bevacizumab 5 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W)
DRUG	FOLFIRI Protocol	FOLFIRI chemotherapy (irinotecan 180 mg/m2 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 hour continuous IV infusion), every two weeks

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2032-03-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

22 sites across 1 country: France