Melanoma Stage IIIB/C/D: Adjuvant Checkpoint Inhibitor Combinations

CheckMate-915 Phase III Trial Results

• October 14, 2022

On September 26, 2022, researchers from Laura and Isaac Perlmutter Cancer Center led by Jeffrey S. Weber published CheckMate-915 Phase III trial results in the Journal of Clinical Oncology, evaluating adjuvant nivolumab plus ipilimumab versus nivolumab monotherapy in resected stage IIIB/C/D melanoma.

Trial Design

Patient Population: Resected stage IIIB/C/D melanoma (n=1833)

Treatment Arms (randomized, double-blind):

• Nivolumab 240 mg every 2 weeks + Ipilimumab 1 mg/kg every 6 weeks (1 year, n=916)
• Nivolumab 480 mg every 4 weeks (1 year, n=917)

Primary Endpoint: Recurrence-free survival

Key Results

Recurrence-Free Survival at 24 Months:

• Nivolumab + ipilimumab: 64.6%
• Nivolumab monotherapy: 63.2%
• No significant difference observed

PD-L1 Negative Subgroup: No significant difference between arms

Safety Profile

Grade 3-4 adverse events:

• Nivolumab + ipilimumab: 32.6%
• Nivolumab: 12.8%
• Treatment-related mortality: 0.4% vs 0% (combination vs monotherapy)

Clinical Conclusions

Nivolumab monotherapy maintains efficacy as adjuvant therapy in resected stage IIIB/C/D melanoma without additional benefit from ipilimumab combination, while avoiding increased toxicity burden.

Data Source

https://ascopubs.org/doi/full/10.1200/JCO.22.00533

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