A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

Brief description of study

The purpose of the study is to determine the efficacy of investigational agents with or without pembrolizumab for the treatment of PD-1 naïve or PD-1 exposed participants with melanoma. The combination of MK-1308A + Lenvatinib or Pembrolizumab + Lenvatinib are evaluated in this study. We want to know the safety and tolerability of the study drugs based on the percentage of participants who will experience adverse events and we also want to know how the participants will respond to the study drugs. The study drug combinations in this study are investigational, which means that it 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: s21-00226
ClinicalTrials.gov Identifier: NCT04700072
Principal Investigator: Janice Mehnert.
Other Investigators: Nila Theresa De La Rosa, Maya Dimitrova, Kathleen M Madden, Jeffrey S. Weber.


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