Title: IRENE study: Phase 2 study of INCMGA00012 and the oncolytic virus pelareorep in metastatic triple negative breast cancer
Principal Investigator: Mridula A. George, MD, of Rutgers Cancer Institute of New Jersey in New Brunswick
Description: Researchers are conducting a phase 2 study to evaluate the safety and efficacy of retifanlimab (INCMGA00012) and pelareorep for patients with metastatic triple-negative breast cancer (TNBC).
Patients will receive pelareorep intravenously over 60 minutes on days 1, 2, 15, and 16 of each 28-day cycle. They will receive retifanlimab intravenously over 60 minutes on day 3 of each cycle. Treatment will continue until disease progression or unacceptable toxicity.
The primary outcomes are objective response rate and the incidence of adverse events. Secondary outcomes include progression-free survival, overall survival, duration of response, and quality of life.
To be eligible for this study, patients must be women who are 18 years of age or older and have a histologically confirmed diagnosis of metastatic or inoperable locally advanced TNBC. They must have received 1-2 prior lines of systemic therapy for metastatic disease. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Rutgers University in collaboration with Incyte Corporation, Oncolytics Biotech, and the National Cancer Institute.
ClinicalTrials.gov. INCMGA00012 and pelareorep for the treatment of metastatic triple negative breast cancer, IRENE study. NCT04445844. Accessed December 13, 2022.