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RECRUITING
NCT07446322
PHASE2

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

Sponsor: Oncolytics Biotech

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-30

Completion Date

2030-04-30

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

DRUG

Bevacizumab

Bevacizumab (5 mg/kg) IV infusion

DRUG

FOLFIRI

irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion

DRUG

Pelareorep

pelareorep 4.5 x 10\^10 TCID50 IV infusion

Locations (13)

Central Alabama Research

Homewood, Alabama, United States

Clinical Research Advisors (Beverly Hills)

Beverly Hills, California, United States

Clinical Research Advisors (Encino)

Encino, California, United States

Clinical Research Advisors (Korea Town)

Koreatown, California, United States

Clinical Research Advisors (Downtown LA)

Los Angeles, California, United States

Clinical Research Advisors (West Hollywood)

Los Angeles, California, United States

Clinical Research Advisors (West Covina)

West Covina, California, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Community Health Network

Indianapolis, Indiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Summit Health Cancer Center

Florham Park, New Jersey, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Gabrail Cancer Center

Canton, Ohio, United States