TY - JOUR
T1 - Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma
T2 - Phase III PIVOT IO 001 study design
AU - Khushalani, Nikhil I
AU - Diab, Adi
AU - Ascierto, Paolo A
AU - Larkin, James
AU - Sandhu, Shahneen
AU - Sznol, Mario
AU - Koon, Henry B
AU - Jarkowski, Anthony
AU - Zhou, Ming
AU - Statkevich, Paul
AU - Geese, William J
AU - Long, Georgina V
PY - 2020
Y1 - 2020
N2 - Nivolumab, a programmed cell death-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).
AB - Nivolumab, a programmed cell death-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).
U2 - 10.2217/fon-2020-0351
DO - 10.2217/fon-2020-0351
M3 - Article
C2 - 32723187
JO - Future Oncology
JF - Future Oncology
SN - 1479-6694
ER -