1. PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence
- Author
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Eggermont, Alexander Mm, Ascierto, Paolo A., Khushalani, Nikhil I., Schadendorf, Dirk, Boland, Genevieve, Weber, Jeffrey, Lewis, Karl D., Johnson, Daniel, Rivalland, Gareth, Khattak, Adnan, Majem, Margarita, Gogas, Helen, Long, Georgina V., Currie, Sue L., Chien, David, Tagliaferri, Mary A., Carlino, Matteo S., Diab, Adi, Eggermont, Alexander Mm, Ascierto, Paolo A., Khushalani, Nikhil I., Schadendorf, Dirk, Boland, Genevieve, Weber, Jeffrey, Lewis, Karl D., Johnson, Daniel, Rivalland, Gareth, Khattak, Adnan, Majem, Margarita, Gogas, Helen, Long, Georgina V., Currie, Sue L., Chien, David, Tagliaferri, Mary A., Carlino, Matteo S., and Diab, Adi
- Abstract
Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.
- Published
- 2022