Early LAG-3 and PD-L1 expression on T cells predict durable response to anti-PD-1 treatment in metastatic melanoma

inferiority randomized trial, like the current study, which is needed to answer the study question.Methods: Grand SLAM is a prospective non-inferiority randomized phase III trial including patients at the university centers in Sweden, Norway and Finland, and also at county hospitals in Sweden.The EORTC melanoma group is in favour of the study.After radical surgery of stage IIB-C, III and IV melanoma, patients are stratified for tumor stage and neoadjuvant treatment and randomly assigned 1:1 to 6 months (experimental arm) or 12 months (standard arm) treatment with either pembrolizumab or nivolumab.Patients with complete or near complete pathological response after neoadjuvant treatment are not eligible.An interim analysis will be conducted when approximately 2/3 of the 1880 patients have been included.The study aim is to investigate whether 6 months of immunotherapy (adjuvant +/-neoadjuvant) in these high-risk patients is as effective as 12 months of treatment.The dual primary endpoints are distant metastasis-free survival (DMFS) and relapsefree survival (RFS) at 2 years.Biomarkers and the role of food supplements for relapse (MelKo) will be investigated in substudies.Results: The study is currently recruiting patients.Conclusions: More centers are welcome to participate.