A Phase 3 Randomized Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

Brief description of study

The purpose of the study is to evaluate the efficacy and safety of bempegaldesleukin plus nivolumab compared with nivolumab. The investigational products in this study are bempegaldesleukin (NKTR-214) in combination with nivolumab, which means that the combination has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.


Clinical Study Identifier: s20-00402
ClinicalTrials.gov Identifier: NCT04410445
Principal Investigator: Jeffrey S. Weber.


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