A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

You likely can't join if

• Patients with known MSI-H/dMMR disease as determined by a health authority approved assay (eg, FDA for United States, CE-IVD marked for Europe, PMDA for Japan, and NMPA for China) conducted at a local clinical laboratory or at the central laboratory.
• Known BRAF V600E mutation status. known DPD deficiency (refer to local fluorouracil label or local clinical guidance for DPD status recommendation prior to starting treatment).
• Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and any other therapy based on the mechanism of action of tumor immunity or angiogenesis
• Symptomatic central nervous system (CNS) metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease. NOTE:- Patients who have stopped corticosteroids or on stable corticosteroid therapy (prednisone ≤ 10 mg daily or equivalent) are allowed.
• Resectable oligometastastic-only disease with multidisciplinary plan for complete resection of all disease.
• Ascites requiring paracentesis within last 30 days.