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FOLFIRI and Bevacizumab With or Without Pelareorep for Metastatic Colorectal Cancer

This study is for people with metastatic colorectal cancer (cancer that has spread) that has a RAS mutation and is microsatellite-stable (MSS). You may be eligible if your cancer has progressed after one prior treatment with oxaliplatin-based chemotherapy. The study is testing if adding pelareorep to the standard treatment of FOLFIRI and bevacizumab is effective. FOLFIRI is a chemotherapy combination, and bevacizumab is a drug that targets blood vessel growth. Researchers will compare how many patients respond to the treatment (Overall Response Rate) when pelareorep is added versus when it is not. About 60 people will participate in this study.

Study design
This is an open-label, randomized study where about 60 participants will be assigned by chance to one of two treatment groups. The study is comparing two different drug combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of measuring treatment response is at week 8. Other assessments will take place at the end of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07446322

FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Oncolytics Biotech
~60 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:BevacizumabFOLFIRIPelareorep

At a glance

Recruiting sites
11 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over At week 8

Conditions

Ras-mutated Metastatic Colorectal Cancer
mCRC
MSS Metastatic Colorectal Cancer

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Where it's being run

13 sites across 7 states
California6
New Jersey2
Alabama1
Georgia1
Indiana1
Missouri1
Ohio1

Who to contact

Name: Reference Study ID Number: REO 033
[email protected]
+1 (858) 247-7829
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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
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 trial measures

  • Overall Response Rate (ORR)At week 8

    Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1