FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
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
Oncolytics Biotech
60 participants
Apr 30, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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
Exclusion Criteria12
- 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
- Active autoimmune disease
- Receiving immunosuppressive or myelosuppressive medications
- 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
- Received any vaccine within 28 days prior to first study treatment
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Interventions
Bevacizumab (5 mg/kg) IV infusion
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
pelareorep 4.5 x 10\^10 TCID50 IV infusion
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07446322