FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Bevacizumab: Bevacizumab (5 mg/kg) IV infusion
FOLFIRI: irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
Pelareorep: pelareorep 4.5 x 10\^10 TCID50 IV infusion
Study 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.
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) — At week 8
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Central Alabama Research | Homewood | Alabama | Recruiting |
| Clinical Research Advisors (Beverly Hills) | Beverly Hills | California | Recruiting |
| Clinical Research Advisors (Encino) | Encino | California | Recruiting |
| Clinical Research Advisors (Korea Town) | Koreatown | California | Recruiting |
| Clinical Research Advisors (Downtown LA) | Los Angeles | California | Recruiting |
| Clinical Research Advisors (West Hollywood) | Los Angeles | California | Recruiting |
| Clinical Research Advisors (West Covina) | West Covina | California | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Emory Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| Beacon Cancer Center | Post Falls | Idaho | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Recruiting |
| Community Health Network | Indianapolis | Indiana | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Summit Health Cancer Center | Florham Park | New Jersey | Recruiting |
| Rutgers Cancer Institute | New Brunswick | New Jersey | Recruiting |
| Gabrail Cancer Center | Canton | Ohio | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Recruiting |
| Ohio State University | Colombus | Ohio | Recruiting |
On this site
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07446322 on ClinicalTrials.gov ↗ ← All trials in the USA