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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Bevacizumab (5 mg/kg) IV infusion
irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
pelareorep 4.5 x 10\^10 TCID50 IV infusion
Central Alabama Research
Homewood, Alabama, United States
RECRUITINGClinical Research Advisors (Beverly Hills)
Beverly Hills, California, United States
RECRUITINGClinical Research Advisors (Encino)
Encino, California, United States
RECRUITINGClinical Research Advisors (Korea Town)
Koreatown, California, United States
RECRUITINGClinical Research Advisors (Downtown LA)
Los Angeles, California, United States
RECRUITINGClinical Research Advisors (West Hollywood)
Los Angeles, California, United States
RECRUITINGClinical Research Advisors (West Covina)
West Covina, California, United States
RECRUITINGEmory Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGBeacon Cancer Center
Post Falls, Idaho, United States
RECRUITINGCommunity Health Network
Indianapolis, Indiana, United States
NOT_YET_RECRUITING...and 5 more locations
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
Overall Survival (OS) -
OS defined as the time from date of randomization to death from any cause
Time frame: From the date of randomization through long term follow up at two years
Progression Free Survival (PFS)
Time from randomization to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.
Time frame: From randomization to objective progression or death from any cause, whichever occurs first, up to two years
Disease Control Rate (DCR)
Overall DCR, defined as the number of patients with a best overall response of CR, PR, or SD according to RECIST v. 1.1
Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
Duration of Response (DOR)
Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.
Time frame: From randomization to disease progression or death from any cause, whichever occurs first, up to two years
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