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
Secondary Outcome:
  • 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society