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Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design.

Authors
  • Khushalani, Nikhil I1
  • Diab, Adi2
  • Ascierto, Paolo A3
  • Larkin, James4
  • Sandhu, Shahneen5
  • Sznol, Mario6
  • Koon, Henry B7
  • Jarkowski, Anthony7
  • Zhou, Ming7
  • Statkevich, Paul7
  • Geese, William J7
  • Long, Georgina V8
  • 1 Moffitt Cancer Center, Tampa, FL 33612, USA.
  • 2 Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX 77030, USA.
  • 3 Unit of Medical Oncology and Innovative Therapy, Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale IRCCS, Napoli, Italy. , (Italy)
  • 4 Department of Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, London, UK.
  • 5 Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Victoria, Australia. , (Australia)
  • 6 Yale Cancer Center, Yale-New Haven Hospital, New Haven, CT 06511, USA.
  • 7 Bristol Myers Squibb, Princeton, NJ 08543, USA.
  • 8 Melanoma Institute Australia, The University of Sydney, Royal North Shore & Mater Hospital, St Leonards, NSW, Australia. , (Australia)
Type
Published Article
Journal
Future Oncology
Publisher
Future Medicine
Publication Date
Oct 01, 2020
Volume
16
Issue
28
Pages
2165–2175
Identifiers
DOI: 10.2217/fon-2020-0351
PMID: 32723187
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Nivolumab, a PD-1 inhibitor, has demonstrated prolonged survival benefit in patients with advanced melanoma. Bempegaldesleukin (BEMPEG; NKTR-214), a first-in-class CD122-preferential IL-2 pathway agonist, provides sustained signaling through the IL-2βγ receptor, which activates effector T and natural killer cells. In the Phase I/II PIVOT-02 trial, the combination of bempegaldesleukin plus nivolumab was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. Here, we describe the design of and rationale for the Phase III, global, randomized, open-label PIVOT IO 001 trial comparing bempegaldesleukin plus nivolumab with nivolumab alone in patients with previously untreated, unresectable or metastatic melanoma. Primary end points include objective response rate, progression-free survival and overall survival. Key secondary end points include further investigation of safety/tolerability, previously assessed in the PIVOT-02 trial. Clinical Trial Registration: NCT03635983 (ClinicalTrials.gov).

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