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

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

Brief description of study

The purpose of the study is to determine and to evaluate the safety as well as efficacy of investigational treatment arms with or without pembrolizumab in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. We want to assess the safety and tolerability of investigational treatment combinations based on the proportion of participants with adverse events (AEs) and we want to to evaluate pathological complete response (pCR) rate as assessed by central review of the pathology results.

Clinical Study Identifier: s21-00757

ClinicalTrials.gov Identifier: NCT04303169

Principal Investigator: Janice Mehnert.

Other Investigators: Nila Theresa De La Rosa, Maya Dimitrova, Kathleen M Madden, Jeffrey S. Weber.

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Perlmutter Cancer Center

Clinical Trials & Research Studies