Posted: Wednesday, June 8, 2022
In the phase II CERPASS trial, the safety and efficacy of combining the monoclonal antibody cemiplimab-rwlc with RP1, an oncolytic virus (HSV-1), are being evaluated in patients with advanced cutaneous squamous cell carcinoma. RP1 functions by expressing a fusogenic glycoprotein and granulocyte-macrophage–colony stimulating factor, and it induced immunogenic tumor cell death in preclinical studies. Andrew Mark Haydon, MD, of the Alfred Hospital, Melbourne, presented the methods of this study on behalf of his colleagues at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS9593).
This trial is currently enrolling patients who have either metastatic or unresectable cutaneous squamous cell carcinoma who will not be undergoing surgery or radiation therapy. Researchers aim to enroll 180 patients from a variety of hospitals in Europe, Australia, Canada, and the United States. Patients will be randomly assigned 2:1 to receive cemiplimab alone or in combination with RP1. Cemiplimab will be given intravenously at a dose of 350 mg every 3 weeks for up to 108 weeks. RP1 will be injected directly into the tumor at a starting dose of 1 x 106 plaque-forming U/mL, followed by up to 7 doses at 1 x 107 plaque-forming U/mL every 3 weeks.
Enrolled patients will be stratified by disease status (nodal, distant metastatic, or locally advanced) and prior systemic therapy. Their tumors will be assessed every 9 weeks to detect signs of disease improvement. Researchers will be evaluating both overall response rate and complete response rate. In addition, safety, progression-free survival, duration of response, and overall survival will be monitored.
Disclosure: For a full list of authors’ disclosures, visit coi.asco.org.