AUTHOR=Wang Yan-Bo , Lv Gang , Xu Feng-Hua , Ma Lin-Lu , Yao Yong-Ming
TITLE=Comprehensive Survey of Clinical Trials Registration for Melanoma Immunotherapy in the ClinicalTrials.gov
JOURNAL=Frontiers in Pharmacology
VOLUME=10
YEAR=2020
URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2019.01539
DOI=10.3389/fphar.2019.01539
ISSN=1663-9812
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 Of them, 30.6% were completed, 16.9% were terminated, and two were withdrawn; 77.7% recruited less than 100 participants; 30.5% were randomized; 45.5% was single group assignment; 88.8% were not masked; the primary purpose was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.