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

Active:	Yes
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT07446322
Trial Phases:	Phase II	Protocol IDs:	REO 033 (primary) NCI-2026-02091
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Oncolytics Biotech
NCI Full Details:	http://clinicaltrials.gov/show/NCT07446322

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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