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
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.
Arms & interventions
- DrugBevacizumab
Bevacizumab (5 mg/kg) IV infusion
- DrugFOLFIRI
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
- DrugPelareorep
pelareorep 4.5 x 10\^10 TCID50 IV infusion
Outcome measures
Primary
Overall Response Rate (ORR)
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
Time frame: At week 8
Secondary
Overall Survival (OS) -
Time frame: From the date of randomization through long term follow up at two years
Progression Free Survival (PFS)
Time frame: From randomization to objective progression or death from any cause, whichever occurs first, up to two years
Disease Control Rate (DCR)
Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Duration of Response (DOR)
Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Eligibility criteria
Study locations (3)
Central Alabama Research
Homewood, Alabama, 35209
Summit Health Cancer Center
Florham Park, New Jersey, 07932
Gabrail Cancer Center
Canton, Ohio, 44718