An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer
This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.
• Histologically confirmed cancer of the colon or rectum with documented metastasis
• Measurable disease per RECIST v. 1.1
• Not candidates for curative surgery or curative radiation
• Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin
• Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab
• Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method
• Tumor confirmed to harbor a known RAS mutation per a standard local testing method
• ECOG performance status of 0 or 1
• Patients must have adequate hematological, renal, and hepatic function
• Female patients of childbearing potential must have a negative pregnancy test
• Life expectancy of at least 6 months