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

PHASE3TerminatedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

August 12, 2020

Primary Completion Date

April 27, 2021

Study Completion Date

September 19, 2023

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

Trial Locations (71)

8

GSK Investigational Site, Dublin

1012

GSK Investigational Site, Buenos Aires

1070

GSK Investigational Site, Brussels

2100

GSK Investigational Site, Copenhagen

2148

GSK Investigational Site, Blacktown

2650

GSK Investigational Site, Edegem

3000

GSK Investigational Site, Melbourne

3084

GSK Investigational Site, Heidelberg

4102

GSK Investigational Site, Woolangabba

10408

GSK Investigational Site, Gyeonggi-do

12203

GSK Investigational Site, Berlin

17100

GSK Investigational Site, Savona

20132

GSK Investigational Site, Milan

21565

GSK Investigational Site, Incheon

25123

GSK Investigational Site, Brescia

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28050

GSK Investigational Site, Madrid

30625

GSK Investigational Site, Hanover

33000

GSK Investigational Site, Bordeaux

42601

GSK Investigational Site, Daegu

46026

GSK Investigational Site, Valencia

58128

GSK Investigational Site, Hwasun

59100

GSK Investigational Site, Florence

67200

GSK Investigational Site, Strasbourg

69373

GSK Investigational Site, Lyon

75005

GSK Investigational Site, Paris

80131

GSK Investigational Site, Napoli

86021

GSK Investigational Site, Poitiers

89075

GSK Investigational Site, Ulm

91010

GSK Investigational Site, Duarte

196603

GSK Investigational Site, Pushkin

200347

GSK Investigational Site, Craiova

400015

GSK Investigational Site, Cluj-Napoca

407280

GSK Investigational Site, Floreşti

720284

GSK Investigational Site, Suceava

C1426ABP

GSK Investigational Site, Buenos Aires

E3100XAD

GSK Investigational Site, Oro Verde Entre RIos

S2000DBS

GSK Investigational Site, Rosario

T4000

GSK Investigational Site, San Miguel de Tucumán

81520-060

GSK Investigational Site, Curitiba

01246-000

GSK Investigational Site, São Paulo

29043-260

GSK Investigational Site, Vitória

T6G 1Z2

GSK Investigational Site, Edmonton

L8V 5C2

GSK Investigational Site, Hamilton

N6A 4G5

GSK Investigational Site, London

M4N 3M5

GSK Investigational Site, Toronto

M5G 2M9

GSK Investigational Site, Toronto

H2X 3E4

GSK Investigational Site, Montreal

04103

GSK Investigational Site, Leipzig

00144

GSK Investigational Site, Roma

541-8567

GSK Investigational Site, Osaka

589-8511

GSK Investigational Site, Osaka

104-0045

GSK Investigational Site, Tokyo

135-8550

GSK Investigational Site, Tokyo

85-796

GSK Investigational Site, Bydgoszcz

81-519

GSK Investigational Site, Gdynia

44-102

GSK Investigational Site, Gliwice

20-090

GSK Investigational Site, Lublin

97-200

GSK Investigational Site, Tomaszów Mazowiecki

02-781

GSK Investigational Site, Warsaw

021389

GSK Investigational Site, Bucharest

075100

GSK Investigational Site, Otopeni

05505

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

08035

GSK Investigational Site, Barcelona

SE-171 64

GSK Investigational Site, Stockholm

SW3 6JJ

GSK Investigational Site, London

NG5 1PB

GSK Investigational Site, Nottingham

SM2 5PT

GSK Investigational Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT04428333 - Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter