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

Projekt

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

Automatisch geschlossen · 2020 bis 2021

Jörger Markus

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Medizinische Onkologie und Hämatologie

Status

Automatisch geschlossen

Start

2020

Ende

2021

Finanzierungsart

Industrie

Studiendesign

Phase II

Schlagwörter (Tags)

GSK3359609, Placebo in Combination with Pembroli-zumab, First-Line Treatment of PD-L1 Positive Recur-rent/Metastatic, Head and Neck Squamous Cell Carcinoma

Kurzbeschreibung/Zielsetzung

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.