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
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Kurzfassung
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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.
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Art des Forschungsprojektes
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Klinische Forschung
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Status
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Laufend - Rekrutierungsphase
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Projektstart
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2020
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Projektende
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2021
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Studiendesign
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Phase II
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Verantwortliche Person / Hauptprüfarzt am KSSG
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Venoika Nagy
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