Phase 3 Study Comparing Ivonescimab Plus FOLFOX Versus Bevacizumab Plus FOLFOX for First-Line Treatment of Metastatic Colorectal Cancer

What this Trial Is About

Researchers are studying the use of Ivonescimab combined with mFOLFOX6 compared to Bevacizumab combined with mFOLFOX6 for patients with metastatic colorectal cancer who have not received previous systemic treatment for their metastatic disease. This phase 3, randomized, double-blind, active-controlled, multicenter trial aims to evaluate first-line treatment options for this condition. Approximately 600 patients will participate in the study, which is sponsored by Summit Therapeutics. Participants will be randomly assigned to receive either Ivonescimab plus mFOLFOX6 or Bevacizumab plus mFOLFOX6 through intravenous infusions every two weeks for up to 8 cycles. Following this initial treatment period, maintenance therapy with Ivonescimab or Bevacizumab combined with Leucovorin and 5-Fluorouracil will be administered on Day 1 of each cycle every two weeks for up to 2 years. Throughout the study, participants will undergo various assessments to monitor their response to treatment, including progression-free survival evaluated by independent review committee using RECIST criteria. Researchers will also track overall survival, objective response rate, duration of response, and adverse events for up to approximately 4 years. The study includes regular infusions and follow-up visits over this treatment and monitoring period.

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer