Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Official Title

A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Summary:

The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx. Approximately 640 participants will be enrolled in the study.

Trial Description

Primary Outcome:

  • Overall Survival (OS) in total population
  • OS in programmed death receptor-ligand 1 (PD-L1) combined positive score (CPS) >=1 population
  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) version (v)1.1 in total population
Secondary Outcome:
  • PFS per RECIST v1.1 in the PD-L1 CPS >=1 population
  • Milestone OS rate at 12, 24 and 36 months in total population
  • Milestone OS rate at 12, 24 and 36 months in PD-L1 CPS >=1 population
  • Overall Response Rate (ORR) per RECIST v1.1 in total population
  • ORR per RECIST v1.1 in PD-L1 CPS >=1 population
  • Disease Control Rate (DCR) per RECIST v1.1 in total population
  • DCR per RECIST v1.1 in PD-L1 CPS >=1 population
  • Duration of Response (DoR) per RECIST v1.1 in total population
  • DoR per RECIST v1.1 in PD-L1 CPS >=1 population
  • Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) in total population
  • Number of participants with adverse Events of Special Interest (AESI) in total population
  • Number of participants with AEs and SAEs in PD-L1 CPS>=1 population
  • Number of participants with AESIs in PD-L1 CPS>=1 population
  • Severity of AEs and SAEs in total population
  • Severity of AESIs in total population
  • Severity of AEs and SAEs in PD-L1 CPS>=1 population
  • Severity of AESI in PD-L1 CPS>=1 population
  • Number of participants with dose modifications in total population
  • Number of participants with dose modifications in PD-L1 CPS>=1 population
  • Time to deterioration in pain in total populations
  • Time to deterioration in pain in PD-L1 CPS >=1 populations
  • Time to deterioration in physical function in total population
  • Time to deterioration in physical function in PD-L1 CPS >=1 population

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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