CheckMate-76K Study Design*
In completely resected Stage IIB or IIC melanoma
CheckMate-76K: A randomized phase III
double-blinded trial1,3*
Checkmate-76K evaluated RFS† with OPDIVO Q4W as adjuvant
treatment for eligible patients with completely resected stage
IIB/IIC melanoma.
790 patients with resected Stage IIB/IIC melanoma
Patients were treated for 1 year or until disease recurrence
or unacceptable toxicity.1
DMFS: distant metastasis-free survival; ECOG: Eastern Cooperative Oncology Group; IV: intravenous; Q4W: every 4 weeks; RFS: recurrence-free survival.
* CheckMate-76K was a phase III randomized, double-blind trial enrolling patients with completely resected Stage IIB or IIC melanoma. Patients were randomized (2:1) to receive OPDIVO (n=526) administered as an intravenous infusion over 30 minutes at 480 mg every 4 weeks or placebo (n=264) and were treated for 1 year or until disease recurrence or unacceptable toxicity. Randomization was stratified by AJCC 8th edition T Stage (T3b vs. T4a vs. T4b); 3-year results.
† RFS, assessed by the investigator, was defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma, or death from any cause, whichever occurs first.