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

April 29, 2026 updated by: Oncolytics Biotech

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 60 patients will be randomized 1:1 to the following study arms:

  • Arm A: FOLFIRI + bevacizumab + pelareorep
  • Arm B: FOLFIRI + bevacizumab The primary endpoint is ORR as assessed by the investigator per RECIST 1.1. OS, PFS, and assessment of the safety and tolerability of the study treatment combinations are secondary endpoints. The primary endpoint analysis will be performed after all patients have had at least one tumor assessment following initiation of study treatment or have progressed. The secondary endpoint analyses will take place at EOS.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Name: Reference Study ID Number: REO 033
  • Phone Number: +1 (858) 247- 7829
  • Email: REO-033@oncolytics.ca

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Central Alabama Research
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Recruiting
        • Summit Health Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Bevacizumab
Bevacizumab (5 mg/kg) IV infusion
Other Names:
  • Avastin
Drug: FOLFIRI
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
Drug: Pelareorep
pelareorep 4.5 x 10^10 TCID50 IV infusion
Experimental: Arm B
Drug: Bevacizumab
Bevacizumab (5 mg/kg) IV infusion
Other Names:
  • Avastin
Drug: FOLFIRI
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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
At week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) -
Time Frame: From the date of randomization through long term follow up at two years
OS defined as the time from date of randomization to death from any cause
From the date of randomization through long term follow up at two years
Progression Free Survival (PFS)
Time Frame: From randomization to objective progression or death from any cause, whichever occurs first, up to two years
Time from randomization to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.
From randomization to objective progression or death from any cause, whichever occurs first, up to two years
Disease Control Rate (DCR)
Time Frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Overall DCR, defined as the number of patients with a best overall response of CR, PR, or SD according to RECIST v. 1.1
From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Duration of Response (DOR)
Time Frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.
From randomization to disease progression or death from any cause, whichever occurs first, up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncolytics Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REO 033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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