RecruitingRas-mutated Metastatic Colorectal CancermCRCMSS Metastatic Colorectal Cancer
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Oncolytics Biotech
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
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
Where it's recruiting
Alabama
Homewood
California
Beverly Hills · Encino · Koreatown · Los Angeles …
Georgia
Atlanta
Indiana
Indianapolis
Missouri
St Louis
New Jersey
Florham Park · New Brunswick
Ohio
Canton
Source: ClinicalTrials.gov · NCT07446322 · last updated 2026-08-26