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

Recruiting now · Phase 2

Conditions studied: Ras-mutated Metastatic Colorectal Cancer, mCRC, MSS Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07446322

Run by

Oncolytics Biotech

People needed

60

Starts

2026-04-30

Expected to finish

2030-04-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Alabama Research — Homewood, Alabama, United States (enrolling)
• Emory Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Summit Health Cancer Center — Florham Park, New Jersey, United States (enrolling)
• Rutgers Cancer Institute — New Brunswick, New Jersey, United States (enrolling)
• Gabrail Cancer Center — Canton, Ohio, United States (enrolling)
• Clinical Research Advisors (West Hollywood) — Los Angeles, California, United States
• Clinical Research Advisors (West Covina) — West Covina, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Community Health Network — Indianapolis, Indiana, United States
• Clinical Research Advisors (Beverly Hills) — Beverly Hills, California, United States
• Clinical Research Advisors (Encino) — Encino, California, United States
• Clinical Research Advisors (Korea Town) — Koreatown, California, United States
• Clinical Research Advisors (Downtown LA) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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