CheckMate 067 (10-year outcomes, nivolumab plus ipilimumab vs. ipilimumab)
Trial question
What is the effect of nivolumab plus ipilimumab in patients with advanced melanoma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 629
629 patients (221 female, 408 male).
Inclusion criteria: patients with previously untreated advanced melanoma.
Key exclusion criteria: active brain metastases or leptomeningeal metastases; ocular melanoma; autoimmune disease; requirement of systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment; prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody.
Interventions
N=314 nivolumab plus ipilimumab (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks).
N=315 ipilimumab (ipilimumab 3 mg/kg every 3 weeks for 4 doses plus placebo).
Primary outcome
Median overall survival at 10 years
71.9 months
19.9 months
71.9 months
53.9 months
36.0 months
18.0 months
0.0 months
Nivolumab plus
ipilimumab
Ipilimumab
Significant
increase ▲
Significant increase in median overall survival at 10 years (71.9 months vs. 19.9 months; HR 1.9, 95% CI 1.54 to 2.27).
Secondary outcomes
Significant increase in melanoma-specific survival at 10 years (52% vs. 23%; HR 2.1, 95% CI 1.69 to 2.56).
Significant increase in progression-free survival at 10 years (31% vs. 6%; HR 2.4, 95% CI 1.96 to 2.86).
Significant increase in objective response (58.3% vs. 19%; OR 6.35, 95% CI 4.38 to 9.22).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with previously untreated advanced melanoma, nivolumab plus ipilimumab was superior to ipilimumab with respect to median overall survival at 10 years.
Reference
Jedd D Wolchok, Vanna Chiarion-Sileni, Piotr Rutkowski et al. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med. 2025 Jan 2;392(1):11-22.
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