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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Sep 2026

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At a glance

  • Drugs Bevacizumab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Pelareorep (Primary) ; Pembrolizumab
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Oncolytics Biotech

Most Recent Events

  • 13 Jul 2026 According to an Oncolytics Biotech media release, The Company believes this approach provides the opportunity to generate early randomized efficacy data from Part A with positioning Part B as a potential registrational study without the need to initiate a separate registrational trial. It also expects to report an initial tumor response update from patients enrolled in Part A by end of 2026 & subject to FDA feedback, initiate enrollment in Part B of the study during the first quarter of 2027
  • 13 Jul 2026 According to an Oncolytics Biotech media release, The Company will hold a Type D meeting with the FDA in early August 2026 to discuss adding a registration-directed Part B to the REO 033 study. Building on the enrolling Part A, Part B would preserve core design elements while increasing enrollment and adding blinded independent central review to support potential accelerated or traditional approval & aims to align with the FDA on a regulatory framework that maintains operational efficiencies
  • 13 Jul 2026 According to an Oncolytics Biotech media release, Most recently, global lead principal investigator Dr. Sanjay Goel and his team opened enrollment at Rutgers Cancer Institute of New Jersey.

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