Kantonsspital St.Gallen
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A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembroli-zumab for First-Line Treatment of PD-L1 Positive Recur-rent/Metastatic Head and Neck Squamous Cell Carcinoma

Markus Joerger

abstract The study will evaluate the efficacy of GSK3359609 in combination with pembrolizumab compared with pem-brolizumab plus placebo as a standard first-line chemo-therapy-free regimen in HNSCC. All participants will be stratified by 2 factors i) PD-L1 CPS status (CPS ≥20 vs. 1≤ CPS <20); ii) HPV status in oropharyngeal cancers (positive vs. negative/unknown) vs non-oropharyngeal cancers then randomly assigned in a 1:1 ratio to the GSK3359609/ pembrolizumab arm or pembroli-zumab/placebo arm.
   
type of project clinical studies
status ongoing - recruiting phase
start of project 2020
end of project 2021
study design Phase II
responsible person Venoika Nagy