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-2βγreceptor, 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.
Original language | English (US) |
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Pages (from-to) | 2165-2175 |
Number of pages | 11 |
Journal | Future Oncology |
Volume | 16 |
Issue number | 28 |
DOIs | |
State | Published - Oct 2020 |
Keywords
- I-O combinations
- IL-2 pathway
- NKTR-214
- bempegaldesleukin
- complete response
- immuno-oncology
- metastatic melanoma
- nivolumab
ASJC Scopus subject areas
- Oncology
- Cancer Research