Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172)

Dirk Schadendorf*, Paolo A. Ascierto, John Haanen, Enrique Espinosa, Lev Demidov, Claus Garbe, Michele Guida, Paul Lorigan, Vanna Chiarion-Sileni, Helen Gogas, Michele Maio, Maria Teresa Fierro, Christoph Hoeller, Patrick Terheyden, Ralf Gutzmer, Tormod K. Guren, Dimitrios Bafaloukos, Piotr Rutkowski, Ruth Plummer, Ashita WaterstonMartin Kaatz, Mario Mandala, Ivan Marquez-Rodas, Eva Muñoz-Couselo, Reinhard Dummer, Elena Grigoryeva, Tina C. Young, Paul Nathan

*Korrespondierende/r Autor/-in für diese Arbeit
5 Zitate (Scopus)

Abstract

Background: Limited data are available on nivolumab in challenging subgroups with advanced melanoma. We report outcomes of nivolumab after prior ipilimumab in patients who are typically excluded from clinical trials. Patients and methods: In this phase II, single-arm, open-label, multicentre study (CheckMate 172), patients with advanced melanoma who progressed on or after ipilimumab received nivolumab 3 mg/kg, every 2 weeks for up to 2 years. The primary objective was incidence of grade ≥3, treatment-related select adverse events (AEs). Results: At a minimum follow-up of 18 months, grade ≥3 treatment-related select AEs with the most variation across subgroups were diarrhoea and colitis (1.1% [n = 11] and 0.3% [n = 3] for the total population [n = 1008]; 0.6% [n = 1] and 0.6% [n = 1] for patients with an asymptomatic central nervous system [CNS] metastasis [n = 165; 16.4%]; 4.5% [n = 3] and 3.0% [n = 2] for patients with an Eastern Cooperative Oncology Group performance status [ECOG PS] of 2 [n = 66; 6.5%]; 2.4% [n = 2] and 0% for those who experienced a grade 3/4 immune-related AE [irAE] with prior ipilimumab [n = 84; 8.3%]; and 0% and 0% for autoimmune disease [n = 25; 2.5%], respectively). Median overall survival was 21.4 months in the total population and was 11.6, 2.4, 21.5, and 18.6 months in patients with a CNS metastasis, ECOG PS 2, a grade 3/4 irAE with prior ipilimumab, and autoimmune disease, respectively. Conclusions: In this large, phase II clinical trial of patients with advanced melanoma who progressed on or after ipilimumab, nivolumab demonstrated a safety profile consistent with that of prior clinical trials. ClinicalTrials.gov ID: NCT02156804.

OriginalspracheEnglisch
ZeitschriftEuropean Journal of Cancer
Jahrgang121
Seiten (von - bis)144-153
Seitenumfang10
ISSN0959-8049
DOIs
PublikationsstatusVeröffentlicht - 11.2019

Strategische Forschungsbereiche und Zentren

  • Forschungsschwerpunkt: Infektion und Entzündung - Zentrum für Infektions- und Entzündungsforschung Lübeck (ZIEL)

Fingerprint

Untersuchen Sie die Forschungsthemen von „Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172)“. Zusammen bilden sie einen einzigartigen Fingerprint.

Zitieren