avelumab plus chemoradiotherapy
avelumab10 mg/kg intravenously on day 1 of the1-week lead-in phase followed by 10 mg/kg avelumab every 2 weeks maintenance therapy for up to 12 months.
placebo plus chemoradiotherapy
placebo intravenously on day 1 of the1-week lead-in phase followed by placebo every 2 weeks maintenance therapy for up to 12 months.
all patient were treated with standard-of-care chemoradiotherapy,consistingof intensity-modulated radiotherapy (IMRT) of 70 Gy. Dose modifications of avelumab, placebo or IMRT werenot permitted.
laHNSCC - 1st line (L1)
double-blind
196 hospitals and cancer treatment centres in 22 countries
P3/ one sided and one interim analysis. Overall survival was planned to be tested by means of ahierarchical testing procedure provided that a significantimprovement in progression-free survival was achievedfavouring the avelumab group. To protect the integrity of the study and to preserve the type I error rate, a fraction of alpha (0.0097) for PFS efficacy will be spent at the interim analysis
The primary objective of prolonging progression-free survival with avelumab plus chemoradiotherapy followed by avelumab maintenance in patients with locally advanced squamous cell carcinoma of the head and neck was not met.