Randomized phase 2 trial of addition of cetuximab to avelumab for advanced cutaneous squamous cell carcinoma

A multicenter phase 2 trial in the USA randomized patients with advanced cutaneous squamous cell carcinoma (cSCC) to cetuximab plus avelumab or avelumab monotherapy, with crossover at progression from avelumab to avelumab plus cetuximab allowed. The median progression-free survival (A) was 11.1 months with the combination versus 3.0 months with avelumab monotherapy (HR 0.48; p=0.018) while after crossover (B) the median PFS was 11.3 months. Grade 3 treatment-related adverse events were reported for 48.3% of the patients with avelumab plus cetuximab and 21.5% of the patients with avelumab monotherapy. The authors conclude that avelumab plus cetuximab