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 2026-06-08
60
Participants Needed
3
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining FOLFIRI chemotherapy, bevacizumab, and pelareorep compared to FOLFIRI plus bevacizumab alone in patients with metastatic colorectal cancer that has a RAS mutation and is microsatellite stable. This study focuses on patients whose cancer has progressed after one prior oxaliplatin-based treatment. It is a Phase 2, open-label, randomized trial conducted across multiple centers. Participants will be randomly assigned to one of two groups: one receiving FOLFIRI plus bevacizumab and pelareorep, and the other receiving FOLFIRI plus bevacizumab without pelareorep. Treatments involve intravenous infusions of these drugs, with dosages including bevacizumab at 5 mg/kg, irinotecan at 180 mg/m2, leucovorin at 400 mg/m2, 5-FU at 400 mg/m2, and pelareorep at 4.5 x 10^10 TCID50. The study's primary goal is to assess tumor response at week 8, with secondary goals including overall survival, progression-free survival, disease control rate, and duration of response monitored up to two years. Throughout the trial, patients will undergo regular tumor assessments using RECIST 1.1 criteria to evaluate treatment response. Researchers will also monitor survival outcomes and safety, including tolerability of the treatment combinations. The primary analysis occurs after all participants have had at least one tumor evaluation or disease progression, with further analyses at the end of the study. Participants’ overall health and organ function will be regularly checked, and the study is expected to continue through long-term follow-up up to two years after treatment starts.
CONDITIONS
Brief 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 documented metastasis
- Measurable disease according to RECIST v. 1.1
- Not eligible for curative surgery or radiation
- Progressed on or intolerant to first-line oxaliplatin-based chemotherapy in metastatic setting or relapsed within 6 months after adjuvant oxaliplatin
- Medically eligible for standard of care FOLFIRI with bevacizumab
- Tumor is non-microsatellite instability high or non-deficient mismatch repair
- Tumor confirmed to have a known RAS mutation
- ECOG performance status of 0 or 1
- Adequate blood, kidney, and liver function
- Negative pregnancy test for females 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 prior anti-cancer treatment
- Previous treatment with irinotecan
- Symptomatic brain metastases
- Active autoimmune disease
- Taking immunosuppressive or myelosuppressive medications
- Active, uncontrolled infections
- Known HIV or active hepatitis B or C needing antiviral treatment
- History of another primary cancer within 3 years except certain skin, prostate, or cervical cancers
- Allergy or known hypersensitivity to study drugs or their classes
- Uncontrolled or severe heart disease
- Received any vaccine within 28 days before first study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive FOLFIRI and bevacizumab with or without pelareorep as second-line treatment for metastatic RAS-mutated, microsatellite-stable colorectal cancer.
Regular visits for treatment administration and tumor assessments
Duration - Up to 2 years
Participants are followed for overall survival and progression-free survival after treatment ends.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 3 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
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
Research Team
N
Name: Reference Study ID Number: REO 033
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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