Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Official Title

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Summary:

The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC). This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC. Approximately 600 participants will be enrolled in the study and will have a follow-up until death.

Trial Description

Primary Outcome:

• Overall survival (OS) in the PD-L1 expression positive (CPS >=1) population
• OS in the PD-L1 expression high (CPS >=20) population
• Progression-free survival (PFS) in the PD-L1 CPS >=1 population

• PFS per immune-based RECIST (iRECIST) in the PD-L1 CPS >=1 population
• PFS per RECIST v1.1 in the PD-L1 CPS >=20 population
• PFS per iRECIST (iPFS) in the PD-L1 CPS >=20 population
• Milestone OS rate at 12 months in the PD-L1 CPS >=1 population
• Milestone OS rate at 24 months in the PD-L1 CPS >=1 population
• Milestone OS rate at 12 months in the PD-L1 CPS >=20 population
• Milestone OS rate at 24 months in the PD-L1 CPS >=20 population
• Overall response rate (ORR) per RECIST v1.1 in the PD-L1 CPS >=1 population
• ORR per RECIST v1.1 in the PD-L1 CPS >=20 population
• Disease control rate (DCR) per RECIST v1.1 in the PD-L1 CPS >=1 population
• DCR per RECIST v1.1 in the PD-L1 CPS >=20 population
• Duration of response (DoR) per RECIST v1.1 in the PD-L1 CPS >=1 population
• DoR per RECIST v1.1 in the PD-L1 CPS >=20 population
• Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
• Number of participants with adverse events of special interest (AESI)
• Number of participants with dose modifications
• Time to deterioration in pain in the PD-L1 CPS >=1 population
• Time to deterioration in pain in the PD-L1 CPS >=20 population
• Time to deterioration in physical function in the PD-L1 CPS >=1 population
• Time to deterioration in physical function in the PD-L1 CPS >=20 population

View this trial on ClinicalTrials.gov