FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
18 Years and older, Male and Female
REO 033 (primary)
NCI-2026-02091
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.
Objectives
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.
Eligibility
- 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
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.