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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

Primary Objective:
To assess the efficacy, in terms of ORR, of FOLFIRI + bevacizumab + pelareorep (Arm A) compared with FOLFIRI + bevacizumab (Arm B) in 2L patients with RAS-mutated, MSS metastatic colorectal cancer (mCRC).
Secondary Objectives:
To assess PFS in both treatment arms.
To assess OS in both treatment arms.
To assess the DCR in both treatment arms.
To assess the DOR in both treatment arms.
To assess the safety and tolerability of FOLFIRI + bevacizumab + pelareorep (Arm A) and of FOLFIRI + bevacizumab (Arm B).

Protocol Number: 072602
Phase: Phase II
Applicable Disease Sites: Colon
Drugs Involved: BEVACIZUMAB
Folfiri
Pelareorep
Principal Investigator: Patrick Boland
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.