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

NCT04428333 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-10-09

Study results available
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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.

Conditions

  • Neoplasms, Head and Neck

Interventions

DRUG

Feladilimab

Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

DRUG

Pembrolizumab

Humanized anti- programmed cell death receptor1 (anti-PD-1) IgG4 mAb

DRUG

Placebo

Sterile normal saline

DRUG

Platinum based chemotherapy

Cisplatin/carboplatin

DRUG

Fluorouracil (5FU)

5-fluorouracil

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2021-04-27
Completion
2023-09-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428333 on ClinicalTrials.gov