Open AccessPIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence
Author(s) -
Alexander Eggermont,
Paolo A. Ascierto,
Nikhil I. Khushalani,
Dirk Schadendorf,
Genevieve M. Boland,
Jeffrey S. Weber,
Karl D. Lewis,
Daniel Johnson,
Gareth Rivalland,
Adnan Khattak,
Margarita Majem,
Helen Gogas,
Georgina V. Long,
Sue Currie,
David Chien,
Mary Tagliaferri,
Matteo S. Carlino,
Adi Diab
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-1286
Subject(s) - nivolumab , medicine , melanoma , adjuvant , oncology , clinical endpoint , ipilimumab , adjuvant therapy , clinical trial , disease , stage (stratigraphy) , immunotherapy , cancer , cancer research , paleontology , biology
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.