Abstract 886TiP
Background
Treatment for advanced melanoma after progression on immunotherapy is limited. H101, a recombinant human type 5 adenovirus with the deletion of E1B and E3 gene, which is the world's first approved oncolytic virus product in China, and has been reported to have anti-tumor activity in some solid tumors. However, there was little evidence regarding the effect of H101 on advanced melanoma. Therefore, we aimed to explore the effect and safety of H101 intra-tumor injection combined with anti-programmed death-1 (anti-PD-1) monoclonal antibody in the treatment of advanced melanoma with previous immunotherapy failure, and to further provide a new method for clinical treatment of melanoma.
Trial design
In this single-site, single-arm, prospective study, it is estimated 10 patients with advanced melanoma with previous immunotherapy failure who receive treatment of H101 combined with anti-PD-1 monoclonal antibody are required. Based on individual conditions, H101 are intratumorally injected on day 1 of every cycle, two weeks for a cycle, with 4 cycles totally. In addition, anti-PD-1 are administered intravenously within 48 hours after H101 injection, with a dosage of 3mg/kg. The injection dose of H101 is determined by the maximum tumor diameter: 5.0×1011 virus particles (vp) (1 vial) for tumor diameter between 1cm and 4cm, and 1×1012 vp (2 vials) for tumor diameter between 4cm and 8cm. The primary endpoint is objective response rate (ORR). The secondary endpoints include duration of response (DOR), disease control rate (DCR), overall survival (OS), quality of life (QOL) and adverse events (AEs). The AEs are monitored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). Study data will be collected using electronic case report form (eCRF) and managed using the electronic data capture system (EDC). Patients are now not yet recruiting and the estimated study duration are 3 years.
Clinical trial identification
Chinese Clinical Trial Registry (Registration No: ChiCTR2200055931).
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.