Actively Recruiting
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Led by Oncolytics Biotech · Updated on 2026-05-05
60
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colon or rectal cancer with metastasis
- Measurable disease by RECIST v. 1.1
- Not eligible for curative surgery or radiation
- Progressed on or intolerant to first-line oxaliplatin-based chemotherapy for metastatic disease or relapsed within 6 months after adjuvant oxaliplatin
- Medically eligible for standard FOLFIRI with bevacizumab
- Tumor is non-MSI-H/non dMMR by local test
- Tumor confirmed to have a known RAS mutation by local test
- ECOG performance status 0 or 1
- Adequate blood, kidney, and liver function
- Negative pregnancy test for women of childbearing potential
- Life expectancy of at least 6 months
You will not qualify if you...
- Received systemic chemotherapy, radiotherapy, or surgery less than 4 weeks before study treatment
- Ongoing grade 2 or higher adverse events related to anti-cancer treatment
- Prior treatment with irinotecan
- Symptomatic brain metastases
- Active autoimmune disease
- Receiving immunosuppressive or myelosuppressive drugs
- Active uncontrolled infections
- Known HIV or active hepatitis B or C requiring antiviral treatment
- History of another primary cancer within 3 years except certain early-stage or treated cancers
- Allergy or hypersensitivity to study drugs or related classes
- Uncontrolled or severe heart disease
- Received any vaccine within 28 days before first study treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Central Alabama Research
Homewood, Alabama, United States, 35209
Actively Recruiting
2
Summit Health Cancer Center
Florham Park, New Jersey, United States, 07932
Actively Recruiting
Research Team
N
Name: Reference Study ID Number: REO 033
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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