NCT07446322 · Oncolytics Biotech
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
What this study is about
This is an where both patients and doctors know the treatment given, randomly assigned, conducted at multiple hospitals Phase 2 study to assess the effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Homewood, Alabama
- Florham Park, New Jersey
- Canton, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations