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
Undergone systemic chemotherapy, radiotherapy, or surgery, <4 weeks before study treatment
Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment
Prior treatment with irinotecan
Symptomatic brain metastases