PIVOT-12: a Phase III Study of Adjuvant Bempegaldesleukin Plus Nivolumab in Resected Stage III/IV Melanoma at High Risk for Recurrence
Year: 2022
Type: article
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.
Source: Future Oncology
Authors: Alexander MM Eggermont, Paolo A Ascierto, Nikhil I Khushalani, Dirk Schadendorf, Genevieve Boland, Jeffrey Weber, Karl D Lewis, Daniel Johnson, Gareth Rivalland, Adnan Khattak, Margarita Majem, Helen Gogas, Georgina V Long, Sue L Currie, David Chien, Mary A Tagliaferri, Matteo S Carlino, Adi Diab
Institutions: University Medical Center Utrecht, Princess Máxima Center, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Moffitt Cancer Center, Essen University Hospital, Massachusetts General Hospital, NYU Langone Health, NYU Langone’s Laura and Isaac Perlmutter Cancer Center, University of Colorado Cancer Center, Ochsner Medical Center, University of Auckland, Auckland City Hospital, Edith Cowan University, Hollywood Private Hospital, Hospital de Sant Pau, National and Kapodistrian University of Athens, The University of Sydney, Melanoma Institute Australia, Nektar Therapeutics (United States), The University of Texas MD Anderson Cancer Center
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4206981469