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

Project

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

Automatically Closed · 2020 until 2021

Jörger Markus

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Medizinische Onkologie und Hämatologie

Status

Automatically Closed

Start Date

2020

End Date

2021

Financing

Industry

Study Design

Phase II

Keywords

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

Brief description/objective

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.