Abstract
Objective: Comprehensively evaluate the immunotherapeutic clinical trials and provide reference for melanoma treatment and research. Methods: The website of ClinicalTrials.gov was searched to retrieve and download all registered clinical trials for melanoma immunotherapy on August 1 (updated on August 25), 2019. All registration trials met the inclusion criteria were collected regardless of the type of study, the status of recruitment, and the results of the study. The general characteristics, methodological characteristics, and the types of immunotherapeutic drugs included of these trials were analyzed. Results: Finally, 242 eligible trials were included and evaluated. Of them, 30.6% were completed, 16.9% were terminated, and two were withdrawn; 77.7% recruited less than 100 participants; 30.5% were randomized; 45.5% was single group assignment; 88.8% were not masked; the primary purpose was treatment; 44.2% had data on monitoring committees; 27.7% used US FDA-regulated immunization drugs; 78.5% without results posted; 43.0% were sponsored by the industry. Immunological checkpoint inhibitors were most often studied, with 53.6% of the trials involving PD-1, the most commonly studied was Nivolumab. Conclusions: Currently, most of the registered clinical trials for melanoma immunotherapy were interventional open-label trials. Most immunotherapy research hotspots were in the FDA-regulated drug product, and a few trials reported available test results. It is necessary to strengthen the supervision of results and explore and disseminate more effective and safe immunotherapy methods.
Highlights
Melanoma is a malignant tumor originating from melanocytes and often occurs in the skin, uvea, oral cavity, intracranial, etc. (Smith et al, 2016; Tang et al, 2017; Yang et al, 2018)
It is reported that the global burden of disease (GBD) of melanoma increased by 51% in 2016 compared with 2015, and the incidence of melanoma increased by 39% (Collaboration, 2018)
A total of 395 records were identified on the ClinicalTrials.gov
Summary
Melanoma is a malignant tumor originating from melanocytes and often occurs in the skin, uvea, oral cavity, intracranial, etc. (Smith et al, 2016; Tang et al, 2017; Yang et al, 2018). The morbidity and mortality of melanoma are not as high as other malignancies, the global burden of disease (GBD) of melanoma is increasing year by year. The 5-year survival rate of advanced melanoma patients is only about 20% (Maio et al, 2015; Hamid et al, 2019). For early melanoma, it can be cured by surgical treatment; immunotherapy, radiation therapy, chemotherapy, targeted therapy, and other treatments are used for the supplementary treatment of surgery or the treatment of patients with unresectable or metastatic melanoma (Wang et al, 2018)
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