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
- Ras-mutated Metastatic Colorectal Cancer
- mCRC
- MSS Metastatic Colorectal Cancer
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Oncolytics Biotech
- Enrolment target
- 60
- Started
- 30 April 2026
- Main results due
- 30 August 2027
- Study sites
- 17
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(17)
Central Alabama Research
Homewood, Alabama, United States
Recruiting
Clinical Research Advisors (Beverly Hills)
Beverly Hills, California, United States
Recruiting
Clinical Research Advisors (Encino)
Encino, California, United States
Recruiting
Clinical Research Advisors (Korea Town)
Koreatown, California, United States
Recruiting
Clinical Research Advisors (Downtown LA)
Los Angeles, California, United States
Recruiting
Clinical Research Advisors (West Hollywood)
Los Angeles, California, United States
Recruiting
Clinical Research Advisors (West Covina)
West Covina, California, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Beacon Cancer Center
Post Falls, Idaho, United States
Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, United States
Recruiting
Community Health Network
Indianapolis, Indiana, United States
Not yet recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Summit Health Cancer Center
Florham Park, New Jersey, United States
Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Recruiting
Showing 17 of 17 sites. 16 of the 17 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07446322. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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