Trial Design and Oversight
melanoma, Cancer
MELANOMA, CANCER
Study participants provided voluntary written informed consent approved by the Institutional Review Board (IRB 18-000427) at the University of California, Los Angeles (UCLA). This investigator-initiated trial was conducted in compliance with ethical guidelines under the FDA investigational new drug (IND) #138873, in accordance with the International Council for Harmonization Good Clinical Practice guidelines and the Declaration of Helsinki. The first author, last author, clinical trial coordinator, and UCLA Data Safety and Monitoring Board (DSMB) continuously monitored the safety and data for all patients. The UCLA DSMB met approximately monthly to provide oversight and to serve as the data and safety monitoring committee as part of the UCLA Jonsson Comprehensive Cancer Center Data and Safety Monitoring Plan. The clinical trial was registered with number NCT04185311.Patients were enrolled at UCLA starting September 2019. The phase Ib study was an open-label, nonrandomized trial that used fixed doses of nivolumab, ipilimumab, and T-VEC, as had previously been FDA approved for other indications, including advanced melanoma. Patients received T-VEC as an intratumoral injection at a concentration of 10