Adjuvant Therapy of Nivolumab Combined with Ipilimumab Versus Nivolumab Alone in Patients with Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)

Jeffrey S. Weber*, Dirk Schadendorf, Michele Del Vecchio, James Larkin, Victoria Atkinson, Michael Schenker, Jacopo Pigozzo, Helen Gogas, Stéphane Dalle, Nicolas Meyer, Paolo A. Ascierto, Shahneen Sandhu, Thomas Eigentler, Ralf Gutzmer, Jessica C. Hassel, Caroline Robert, Matteo S. Carlino, Anna Maria Di Giacomo, Marcus O. Butler, Eva Muñoz-CouseloMichael P. Brown, Piotr Rutkowski, Andrew Haydon, Jean Jacques Grob, Jacob Schachter, Paola Queirolo, Luis De La Cruz-Merino, Andre Van Der Westhuizen, Alexander M. Menzies, Sandra Re, Tuba Bas, Veerle De Pril, Julia Braverman, Daniel J. Tenney, Hao Tang, Georgina V. Long

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

68 Scopus citations

Abstract

PURPOSEIpilimumab and nivolumab have each shown treatment benefit for high-risk resected melanoma. The phase III CheckMate 915 trial evaluated adjuvant nivolumab plus ipilimumab versus nivolumab alone in patients with resected stage IIIB-D or IV melanoma.PATIENTS AND METHODSIn this randomized, double-blind, phase III trial, 1,833 patients received nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks (916 patients) or nivolumab 480 mg once every 4 weeks (917 patients) for ≤ 1 year. After random assignment, patients were stratified by tumor programmed death ligand 1 (PD-L1) expression and stage. Dual primary end points were recurrence-free survival (RFS) in randomly assigned patients and in the tumor PD-L1 expression-level < 1% subgroup.RESULTSAt a minimum follow-up of approximately 23.7 months, there was no significant difference between treatment groups for RFS in the all-randomly assigned patient population (hazard ratio, 0.92; 95% CI, 0.77 to 1.09; P =.269) or in patients with PD-L1 expression < 1% (hazard ratio, 0.91; 95% CI, 0.73 to 1.14). In all patients, 24-month RFS rates were 64.6% (combination) and 63.2% (nivolumab). Treatment-related grade 3 or 4 adverse events were reported in 32.6% of patients in the combination group and 12.8% in the nivolumab group. Treatment-related deaths were reported in 0.4% of patients in the combination group and in no nivolumab-treated patients.CONCLUSIONNivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks did not improve RFS versus nivolumab 480 mg once every 4 weeks in patients with stage IIIB-D or stage IV melanoma. Nivolumab showed efficacy consistent with previous adjuvant studies in a population resembling current practice using American Joint Committee on Cancer eighth edition, reaffirming nivolumab as a standard of care for melanoma adjuvant treatment.

Original languageEnglish
Pages (from-to)517-527
Number of pages11
JournalJournal of Clinical Oncology
Volume41
Issue number3
DOIs
StatePublished - 20 Jan 2023
Externally publishedYes

Funding

FundersFunder number
Bristol-Myers Squibb

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