- Title
- Adjuvant Therapy of Nivolumab Combined with Ipilimumab Versus Nivolumab Alone in Patients with Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)
- Creator
- Weber, Jeffrey S.; Schadendorf, Dirk; Ascierto, Paolo A.; Sandhu, Shahneen; Eigentler, Thomas; Gutzmer, Ralf; Hassel, Jessica C.; Robert, Caroline; Carlino, Matteo S.; Di Giacomo, Anna Maria; Butler, Marcus O.; Muñoz-Couselo, Eva; Del Vecchio, Michele; Brown, Michael P.; Rutkowski, P; Haydon, A; Grob, J-J; Schachter, J; Queirolo, P; de la Cruz-Merino, L; van der Westhuizen, Andre; Menzies, AM; Re, S; Larkin, James; Bas, T; de Pril, V; Braverman, J; Tenney, DJ; Tang, H; Long, GV; Atkinson, Victoria; Schenker, Michael; Pigozzo, Jacopo; Gogas, Helen; Dalle, Stéphane; Meyer, Nicolas
- Relation
- Journal of Clinical Oncology Vol. 41, Issue 3, p. 517-527
- Publisher Link
- http://dx.doi.org/10.1200/JCO.22.00533
- Publisher
- American Society of Clinical Oncology
- Resource Type
- journal article
- Date
- 2023
- Description
- Purpose: Ipilimumab 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 Methods: In 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. Results: At 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 5 .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. Conclusion: Nivolumab 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.
- Subject
- melanoma; patients; nivolumab; treatment; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1480886
- Identifier
- uon:50584
- Identifier
- ISSN:0732-183X
- Language
- eng
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