Ras-mutated Metastatic Colorectal CancerPhase 2NCT07446322
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
A Phase 2 study testing Bevacizumab, FOLFIRI and Pelareorep in people with Ras-mutated Metastatic Colorectal Cancer and mCRC, run by Oncolytics Biotech at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ras-mutated Metastatic Colorectal Cancer, mCRC, MSS Metastatic Colorectal Cancer
- What is being tested?
- Bevacizumab, FOLFIRI and Pelareorep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Apr 2026to 30 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30302
Armand Fernandez, 404-778-8201, armand.falqueza.fernandez@emory.edu
Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu
- Recruiting
Clinical Research Advisors (Beverly Hills)
Beverly Hills, California, 90211
Ali Muhammad, MD, MBA, 310-432-8934, AMuhammad@bhcancercenter.com
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
Carrie Smith, 330-417-8231, recruitment@gabrailcancercenter.com
Kimberly Roby, 330-492-3345 ext. 227, recruitment@gabrailcancercenter.com
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
clinicaltrials@northwestern.edu
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Ohio State University
Colombus, Ohio, 43210
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Taylor Brewer, brewert@karmanos.org
- Recruiting
Clinical Research Advisors (Encino)
Encino, California, 91316
- Recruiting
Summit Health Cancer Center
Florham Park, New Jersey, 07932
Michelle Mackenzie, 973-436-1755, mmackenzie@summithealth.com
- Recruiting
Central Alabama Research
Homewood, Alabama, 35209
Lorie Syzmela, 205-949-1907, lszymela@centralalabamaresearch.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Community Health Network
Indianapolis, Indiana, 46250
Mindy Thacker, 317-621-4300, MThacker@ecommunity.com
- Recruiting
Clinical Research Advisors (Korea Town)
Koreatown, California, 90020
- Recruiting
Clinical Research Advisors (Downtown LA)
Los Angeles, California, 90033
- Recruiting
Clinical Research Advisors (West Hollywood)
Los Angeles, California, 90048
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Christian F Misdary, 732-735-3626, cm1344@cinj.rutgers.edu
- Recruiting
Beacon Cancer Center
Post Falls, Idaho, 83854
Kaitie Bean, 208-755-2804 ext. 204, kbean@yourbeaconclinic.com
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Justin Stout, 314-362-2582, justinjstout@wustl.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Cheyenne Schneider, 813-745-5166, Cheyenne.Schneider@moffitt.org
- Recruiting
Clinical Research Advisors (West Covina)
West Covina, California, 91790
About this study
Official title: 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.
Read the 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.
- Being tested
- Bevacizumab, FOLFIRI, Pelareorep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab (5 mg/kg) IV infusion
FOLFIRIDrug
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
PelareorepDrug
pelareorep 4.5 x 10^10 TCID50 IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Bevacizumab; Drug: FOLFIRI; Drug: Pelareorep |
| Arm B | Experimental | Not described Receives: Drug: Bevacizumab; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Proportion of patients with complete response [CR], partial response [PR] assessed by the investigators and/or central reader according to RECIST v1.1
Measured: At week 8
Secondary outcomes (4)
Overall Survival (OS) -
OS defined as the time from date of randomization to death from any cause
Measured: From the date of randomization through long term follow up at two years
Progression Free Survival (PFS)
Time from randomization to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.
Measured: From randomization to objective progression or death from any cause, whichever occurs first, up to two years
Disease Control Rate (DCR)
Overall DCR, defined as the number of patients with a best overall response of CR, PR, or SD according to RECIST v. 1.1
Measured: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Duration of Response (DOR)
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.
Measured: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start30 Apr 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ras-mutated Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncolytics Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446322
- Sponsor's protocol ID
- REO 033
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446322
- Acronym / sponsor ID
- REO 033
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oncolytics BiotechIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Bevacizumab, Drug: FOLFIRI, Drug: Pelareorep |
| Arm B | Experimental | Drug: Bevacizumab, Drug: FOLFIRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab (5 mg/kg) IV infusion | Drug | Arm A, Arm B |
| FOLFIRIirinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion | Drug | Arm A, Arm B |
| Pelareoreppelareorep 4.5 x 10^10 TCID50 IV infusion | Drug | Arm A |
Primary outcome
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
4 secondary outcomes
Overall Survival (OS) -
Time frame: 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
Disease Control Rate (DCR)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, FOLFIRI and Pelareorep in people with Ras-mutated Metastatic Colorectal Cancer and mCRC, run by Oncolytics Biotech at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Name: Reference Study ID Number: REO 033 (+1 (858) 247-7829, REO-033@oncolytics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.