FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Start Date
4/30/2026
Completion Date
4/30/2030
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Bevacizumab
FOLFIRI
Pelareorep
Conditions
Locations
Central Alabama Research
Homewood, Alabama 35209
United States
Clinical Research Advisors (Beverly Hills)
Beverly Hills, California 90211
United States
Clinical Research Advisors (Encino)
Encino, California 91316
United States
Clinical Research Advisors (Korea Town)
Koreatown, California 90020
United States
Clinical Research Advisors (Downtown LA)
Los Angeles, California 90033
United States
Clinical Research Advisors (West Hollywood)
Los Angeles, California 90048
United States
Clinical Research Advisors (West Covina)
West Covina, California 91790
United States
Emory Winship Cancer Institute
Atlanta, Georgia 30302
United States
Community Health Network
Indianapolis, Indiana 46250
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Summit Health Cancer Center
Florham Park, New Jersey 07932
United States
Rutgers Cancer Institute
New Brunswick, New Jersey 08901
United States
Gabrail Cancer Center
Canton, Ohio 44718
United States