FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer

Prior treatment

• Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment
• Prior treatment with irinotecan
• Receiving immunosuppressive or myelosuppressive medications
• Received any vaccine within 28 days prior to first study treatment

Other illness

• Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment
• Active autoimmune disease
• Active, uncontrolled infections
• Known HIV infection or active hepatitis B or C that requires anti-viral treatment
• History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ
• History of allergy or known hypersensitivity to any of the study drugs, study drug classes,
• Uncontrolled or severe cardiac disease

Other

• Symptomatic brain metastases

• 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