Pelareorep added to chemotherapy for advanced colorectal cancer after first treatment stopped working
Tests adding pelareorep to FOLFIRI and bevacizumab in advanced RAS-mutated colorectal cancer.
Plain-language title generated from the registry record
Registry title: FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Key facts
- Where
- Atlanta, Beverly Hills, Canton, Chicago, Cincinnati, Colombus, Detroit, Encino, Florham Park, Homewood, Houston, Indianapolis, Koreatown, Los Angeles, New Brunswick, Post Falls, St Louis, Tampa, and West Covina, United StatesSee the 20 sites
- Phase
- Phase 2
Where in United States
- Emory Winship Cancer InstituteAtlanta, United StatesTaking people
- Clinical Research Advisors (Beverly Hills)Beverly Hills, United StatesTaking people
- Gabrail Cancer CenterCanton, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- Ohio State UniversityColombus, United StatesTaking people
- Karmanos Cancer InstituteDetroit, United StatesTaking people
- Clinical Research Advisors - EncinoEncino, United StatesTaking people
- Summit Health Cancer CenterFlorham Park, United StatesTaking people
- Central Alabama ResearchHomewood, United StatesTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- Community Health NetworkIndianapolis, United StatesTaking people
- Clinical Research Advisors (Korea Town)Koreatown, United StatesTaking people
- Clinical Research Advisors - West HollywoodLos Angeles, United StatesTaking people
- Clinical Research Advisors (Downtown LA)Los Angeles, United StatesTaking people
- Rutgers Cancer InstituteNew Brunswick, United StatesTaking people
- Beacon Cancer CenterPost Falls, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- Clinical Research Advisors (West Covina)West Covina, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oncolytics Biotech
- Trial code
- NCT07446322
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Symptomatic brain metastases.