PIVOT-12 : a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence
Eggermont, Alexander (Princess Máxima Center for Pediatric Oncology & University Medical Center Utrecht)
Ascierto, Paolo A. (Istituto Nazionale Tumori IRCCS Fondazione G Pascale)
Khushalani, Nikhil I. (H Lee Moffitt Cancer Center & Research Institute)
Schadendorf, Dirk (West German Cancer Center at the University Hospital Essen)
Boland, Genevieve (Massachusetts General Hospital (Boston))
Weber, Jeffrey (Perlmutter Cancer Center at NYU Langone Health)
Lewis, Karl D. (University of Colorado Cancer Center)
Johnson, Daniel (Ochsner Medical Center)
Rivalland, Gareth (University of Auckland & Auckland City Hospital)
Khattak, Adnan (Hollywood Private Hospital. Edith Cowan University)
Majem, Margarita (Institut d'Investigació Biomèdica Sant Pau)
Gogas, Helen (National & Kapodistrian University of Athens)
Long, Georgina V. (Melanoma Institute Australia. University of Sydney. Royal North Shore & Mater Hospitals)
Currie, Sue L. (Nektar Therapeutics, San Francisco, CA 94158, USA)
Chien, David (Nektar Therapeutics, San Francisco, CA 94158, USA)
Tagliaferri, Mary A. (Nektar Therapeutics, San Francisco, CA 94158, USA)
Carlino, Matteo S. (Westmead & Blacktown Hospitals & Melanoma Institute Australia. University of Sydney)
Diab, Adi (University of Texas MD Anderson Cancer Center)

Fecha:	2022
Resumen:	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.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Adjuvant ; Bempegaldesleukin ; Cutaneous melanoma ; IL-2 pathway ; Immune checkpoint inhibitor combinations ; Immunotherapy ; Nivolumab ; NKTR-214 ; PD-1 ; PD-L1
Publicado en:	Future oncology (London, England), Vol. 18 Núm. 8 (january 2022) , p. 903-913, ISSN 1744-8301

DOI: 10.2217/fon-2021-1286
PMID: 35073733

11 p, 3.4 MB

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