A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE)

May 21, 2026 updated by: GlaxoSmithKline

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

864

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Barros
      • Buenos Aires, Argentina, C1425
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Martin Paskevicius
      • Buenos Aires, Argentina, C1437GZT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dante Goy
      • Ciudad Autonoma de Buenos Aire, Argentina, C1426
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Fuentes
      • Córdoba, Argentina, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Salinas
      • Florida, Argentina, 1602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Lopez
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herman Perroud
      • San Juan, Argentina, J5400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Puig
      • San Miguel de Tucumán, Argentina, T4000GTB
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Felipe Palazzo
        • Contact:
        • Contact:
      • Viedma, Argentina, R8500ACE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rubén Kowalyszyn
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosemary Habib
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shivanshan Pathmanathan
      • Herston, Queensland, Australia, 4029
        • Withdrawn
        • GSK Investigational Site
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Brown
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Madhu Singh
      • Melbourne, Victoria, Australia, 3004
        • Completed
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Pascal Machiels
      • Charleroi, Belgium, 6060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aurélie Louvet
      • Edegem, Belgium, 2650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marika Rasschaert
      • Ghent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Saerens
      • Liège, Belgium, 4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aurelie Poncin
      • Yvoir, Belgium, 5530
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Henry
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Dix Junqueira Pinto
      • Belo Horizonte, Brazil, 30110-022
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elisa Ramos
      • Florianópolis, Brazil, 88020-210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabricio Grando
      • Ijuí, Brazil, 98700-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafaela Piccoli
      • Jaú, Brazil, 17210-120
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Patricia Beato
        • Contact:
        • Contact:
      • Joinville, Brazil, 89201-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Célio Kussumoto
      • Natal, Brazil, 59075-740
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Silvio Sales
      • Porto Alegre, Brazil, 90610-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernanda Ramos
      • Salvador, Brazil, 41253-190
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dyego Lucas Pereira Nunes
      • Salvador, Brazil, 41950-640
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dalvaro de Castro Junior
      • São José do Rio Preto, Brazil, 15090-200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luiza Ferreira
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gilberto de Castro
      • Vitória, Brazil, 29043-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • GLAUCIO BERTOLLO
  • Canada
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Emack
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Baskoro Kartolo
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Spreafico
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Completed
        • GSK Investigational Site
  • China
      • Beijing, China, 100036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yan Sun
      • Changsha, China, 410013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaqian Han
      • Changzhou, China, 213032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhonghua Lu
      • Chengdu, China, 610000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Peng Zhang
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lei Liu
      • Dongguan, China, 523059
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhigang Liu
      • Fuzhou, China, 350005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jinsheng Hong
      • Fuzhou, China, 350014
        • Active, not recruiting
        • GSK Investigational Site
      • Guangzhou, China, 510120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yimin Liu
      • Guangzhou, China, 510503
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Weidong Li
        • Contact:
        • Contact:
      • Hangzhou, China, 310003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yulong Zheng
      • Hangzhou, China, 310022
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Feng Jiang
        • Contact:
        • Contact:
      • Hefei, China, 230001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Gao
      • Hengyang, China, 421000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaohong Ai
      • Jinan, China, 250117
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Man Hu
      • Kunming, China, 650106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chuanzheng Sun
      • Lanzhou, China, 730030
        • Active, not recruiting
        • GSK Investigational Site
      • Linyi, China, 276002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bingjian Huang
      • Nanchang, China, 330006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianwu Ding
      • Nanchang, China, 330029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jingao Li
      • Nanning, China, 530021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Song Qu
      • Shanghai, China, 200032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chaosu Hu
      • Taiyuan, China, 030013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guanghua Mao
      • Wuhan, China, 430030
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Guangyuan Hu
        • Contact:
        • Contact:
      • Wuhan, China, 430079
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guang Han
      • Xiamen, China, 361004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sangang Wu
      • Xuzhou, China, 221004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ding xin
      • Zhengzhou, China, 450052
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chang Zhiwei
      • Zhuhai, China, 519001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Siyang Wang
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yue Xie
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongyun Shi
    • Henan
      • Nanyang, Henan, China, 473005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wan Lixin
  • Czechia
      • Olomouc, Czechia, 779 00
        • Withdrawn
        • GSK Investigational Site
      • Prague, Czechia, 10034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kateřina Licková
      • Prague, Czechia, 150 08
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michaela Jirkovská
      • Prague, Czechia, 180 81
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petra Beran Holeckova
      • Zlín, Czechia, 76275
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marketa Pospiskova
        • Contact:
        • Contact:
  • France
      • Ars-Laquenexy, France, 57530
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Campitiello
      • Caen, France, 14075
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emeline Guiard
      • Dijon, France, 21079
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sylvie Zanetta
        • Contact:
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sébastien Salas
      • Poitiers, France, 86021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Camille Evrard
      • Quimper, France, 29000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josselin Annic
      • Rennes, France, 35042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florian Estrade
      • Rouen, France, 76038
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florian Clatot
      • Vandœuvre-lès-Nancy, France, 54519
        • Completed
        • GSK Investigational Site
  • Germany
      • Augsburg, Germany, 86156
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Johannes Döscher
      • Berlin, Germany, 12351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maike de Wit
      • Berlin, Germany, 13353
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcus Beck
      • Erlangen, Germany, 91054
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marlen Haderlein
      • Essen, Germany, 45147
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Gauler
      • Giessen, Germany, 35392
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christine Langer
      • Hamburg, Germany, 22087
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Ebeling
      • Neuruppin, Germany, 16816
        • Withdrawn
        • GSK Investigational Site
      • Straubing, Germany, 94315
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoniu-Oreste Gostian
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda Psyrri
      • Athens, Greece, 115 22
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Panagiotis Gouveris
      • Larissa, Greece, 41100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Athanasios Kotsakis
      • Thessaloniki, Greece, 564 29
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofia Baka
  • Hungary
      • Győr, Hungary, 9023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • András Szigeti
      • Kaposvár, Hungary, 7400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eva Somogyine Ezer
      • Nyíregyháza, Hungary, H-4400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ágnes Wéber
  • India
      • Bengaluru, India, 560066
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shashidhar Karpurmath
      • Bhubaneswar, India, 751019
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandip Kumar Barik
      • Gurgaon, India, 122001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Priya Tiwari
      • Hyderabad, India, 500004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Radhika Parimkayala
      • Mumbai, India, 400012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kumar Prabhash
      • Nashik, India, 422002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raj Nagakar
      • Nehru Nagar Belagavi Karnataka 590010, India, 590010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rohan Bhise
      • Surat, India, 395002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ghanshyam Patel
      • Vijayawada, India, 520002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lakshmi Priyadarshini K
    • Maharashtra
      • Mumbai, Maharashtra, India, 400071
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Sangeeta Jiwatani
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr Minish Jain
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eli Sapir
      • Haifa, Israel, 3109601
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salem Billan
      • Jerusalem, Israel, 9112001
        • Withdrawn
        • GSK Investigational Site
      • Tel Aviv, Israel, 64239
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Inbar Finkel
        • Contact:
        • Contact:
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alicia Tosoni
        • Contact:
        • Contact:
      • Milan, Italy, 20133
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Licitra
      • Milan, Italy, 20141
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franco Nolè
      • Naples, Italy, 80131
        • Withdrawn
        • GSK Investigational Site
      • Pavia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilaria Imarisio
      • Prato, Italy, 59100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giacomo Baldi
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandra Cassano
      • Roma, Italy, 00161
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessio Cirillo
      • Rozzano MI, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paolo Bossi
        • Contact:
        • Contact:
      • Savona, Italy, 17100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Benasso
    • Prov. Aut. Bolzano-Alto Adige
      • Bolzano, Prov. Aut. Bolzano-Alto Adige, Italy, 39100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luca Tondulli
  • Japan
      • Aichi, Japan, 464-8681
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuhiro Hanai
      • Aomori, Japan, 036-8563
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Kasai
      • Chiba, Japan, 277-8577
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Makoto Tahara
      • Chiba, Japan, 260-8717
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Takashi Kinoshita
        • Contact:
        • Contact:
      • Ehime, Japan, 791-0280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuya Monden
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mioko Matsuo
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • KAZUAKI CHIKAMATSU
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satoshi Kano
      • Hyōgo, Japan, 650-0017
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naomi Kiyota
      • Hyōgo, Japan, 673-8558
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hirotaka Suto
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masaru Yamashita
      • Kanagawa, Japan, 236-0004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuhiko Oridate
      • Kanagawa, Japan, 259-1193
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenji Okami
      • Kanagawa, Japan, 252-0375
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Taku Yamashita
      • Kyoto, Japan, 612-8555
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryo Asato
      • Miyagi, Japan, 981-1293
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ayako Nakanome
      • Niigata, Japan, 951-8520
        • Completed
        • GSK Investigational Site
      • Numakunai, Japan, 028-3695
        • Completed
        • GSK Investigational Site
      • Okinawa, Japan, 901-2725
        • Active, not recruiting
        • GSK Investigational Site
      • Osaka, Japan, 541-8567
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Fujii
      • Saitama, Japan, 350-1298
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoko Yamazaki
      • Shizuoka, Japan, 411-8777
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoya Yokota
      • Tokyo, Japan, 160-0023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kiyoaki Tsukahara
      • Tokyo, Japan, 105-8471
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masato Nagaoka
      • Tokyo, Japan, 113-8519
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sadakatsu Ikeda
      • Tokyo, Japan, 152-8902
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shujiro Minami
      • Tottori, Japan, 683-8504
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazunori Fujiwara
  • Mexico
      • Guadajalara, Mexico, 44280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Carlos Vazquez Limon
      • Guadalajara, Mexico, 44650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gilberto Lopez Rosas
      • Mexico City, Mexico, 06760
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raul Rogelio Trejo-Rosales
      • Mexico City, Mexico, 11510
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eduardo Cardenas-Cardenas
      • Monterrey, Mexico, 66260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario Alberto Sánchez Prieto
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Ivan Romero Diaz
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Silje Haukedal
      • Oslo, Norway, 0379
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Åse Bratland
      • Troms, Norway, 9038
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Karsten Kilvær
  • Poland
      • Bielsko-Biala, Poland, 43-300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maciej Pysz
      • Gliwice, Poland, 44-102
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomasz Rutkowski
        • Contact:
        • Contact:
      • Katowice, Poland, 40-514
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacek Kabut
      • Olsztyn, Poland, 10-228
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Surus-Hyla
      • Przemyśl, Poland, 37-700
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kamil Kuc
      • Siedlce, Poland, 08-110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lubomir Bodnar
      • Warsaw, Poland, 04-141
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Szymon Borowiec
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Margarida Pimparel
      • Faro, Portugal, 8000-386
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joana Magalhaes
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leonor Ribeiro
      • Lisbon, Portugal, 1998-018
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diogo Alpuim Costa
      • Matosinhos Municipality, Portugal, 4464-509
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Vilaca
      • Porto, Portugal, 4200-072
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cláudia Vieira
      • Porto, Portugal, 4200-319
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucia Aguas
      • Vila Nova de Gaia, Portugal, 4434-502
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Silva
  • Romania
      • Bucharest, Romania, 020142
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula Toma
      • Bucharest, Romania, 013823
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Iordan
      • Craiova, Romania, 200542
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Schenker
      • Craiova, Romania, 200508
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Visan
      • Floreşti, Romania, 407280
        • Withdrawn
        • GSK Investigational Site
      • Iași, Romania, 700483
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vlad Afrasanie
      • Oradea, Romania, 410469
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amalia Hora
      • Piteşti, Romania, 110283
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adela-Luiza Chirila
      • Suceava, Romania, 720214
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Doina Ganea
      • Timișoara, Romania, 300239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra Kovacs
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12372
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hashem Al Hashem
      • Riyadh, Saudi Arabia
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed Aldehaim
  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elise Vong
      • Singapore, Singapore, 168583
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mei-Kim Ang
  • South Korea
      • Busan, South Korea, 602-030
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Seong-Hoon Shin
        • Contact:
        • Contact:
      • Pusan, South Korea, 49241
        • Withdrawn
        • GSK Investigational Site
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye Ryun Kim
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyun Ae Jung
      • Seoul, South Korea, 110 744
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bhumsuk Keam
      • Suwon Gyeonggi-do, South Korea, 16247
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ho Jung An
  • Spain
      • BaracaldoVizcaya, Spain, 48903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Berezi Ortega Gallastegi
      • Barcelona, Spain, 08023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roxana Reyes Cabanillas
      • Cartagena Murcia, Spain, 30202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María José Martínez Ortíz
      • HebrOn, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irene Brana
      • Jerez de la Frontera, Spain, 11407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Silvia Silva Romeiro
      • L'Hospitalet de Llobrega, Spain, 08908
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • María Plana Serrahima
        • Contact:
        • Contact:
      • Lugo, Spain, 27003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Covela Rúa
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Beatriz Castelo Fernandez
        • Contact:
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Santiago Cabezas Camarero
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lara Iglesias Docampo
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Virginia Arrazubi Arrula
      • Salamanca, Spain, 37007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alejandro Olivares Hernández
      • Santander, Spain, 39008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Sotelo García
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • EUGENIA ORTEGA
  • Sweden
      • Gothenburg, Sweden, SE-413 45
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hedda Haugen Cange
      • Stockholm, Sweden, SE-171 64
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanna Carstens
      • Uppsala, Sweden, SE-751 85
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valentina Mouratidou
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Brandt
      • Fribourg, Switzerland, 1708
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruth Gabriela Herrera Gomez
      • Geneva, Switzerland, 1211
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolas Mach
      • Lausanne, Switzerland, 1011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petr Szturz
      • Zurich, Switzerland, 8091
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomas Brezina
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin-Ching Lin
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shau-Hsuan Li
      • Taichung, Taiwan, 40447
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ching-Yun Hsieh
      • Taipei, Taiwan, 100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Huai-Cheng Huang
  • Turkey (Türkiye)
      • Adapazarı, Turkey (Türkiye)
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilhan Hacibekiroglu
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Musa Barış Aykan
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sercan Aksoy
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Umut Demirci
      • Antalya, Turkey (Türkiye), 7050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Derya Kıvrak Salim
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sahin Lacin
      • Istanbul, Turkey (Türkiye), 34662
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • faysal dane
    • Şişli
      • Istanbul, Şişli, Turkey (Türkiye), 34384
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kayhan ERTURK
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amin Abyad
      • Al Ain City, United Arab Emirates
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emad Dawoud
      • Dubai, United Arab Emirates
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fathi Azribi
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Noble
      • Gloucester, United Kingdom, GL1 3NN
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Warren Grant
        • Contact:
        • Contact:
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ben O'Leary
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Judith Christian
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ben O'Leary
      • Wolverhampton, United Kingdom, WV10 0QP
        • Withdrawn
        • GSK Investigational Site
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mazen Khalil
        • Contact:
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deborah Wong
      • Solvang, California, United States, 93463
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryan Kendle
      • Stockton, California, United States, 95204
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dheeraj Kodali
      • Torrance, California, United States, 90505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Justin Tiulim
    • Connecticut
      • Farmington, Connecticut, United States, 06030-1628
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Upendra Hegde
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Barbara Burtness
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Gallagher
    • Florida
      • St. Petersburg, Florida, United States, 33709
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Neeharika Makani
      • Tamarac, Florida, United States, 33321
        • Withdrawn
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dong Shin
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahad Sadiq
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Douglas Laux
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Susanne Arnold
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Najeff Waseem
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655-0002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Walsh
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Oppelt
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yungpo Su
    • New York
      • New York, New York, United States, 10032
        • Completed
        • GSK Investigational Site
      • The Bronx, New York, United States, 10468
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yeun-Hee Park
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nashat Gabrail
      • Cincinnati, Ohio, United States, 45219
        • Completed
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byron Jennings
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jascha Rubin
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Larisa Greenberg
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Kaczmar
      • Greenville, South Carolina, United States, 29607
        • Completed
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Merriman
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • G Tian
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Merriman
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Nadler
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ray Page
        • Contact:
        • Contact:
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Krishna Alluri
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Vaughn
      • Wytheville, Virginia, United States, 24382
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jerome Goldschmidt
        • Contact:
        • Contact:
    • Washington
      • Tacoma, Washington, United States, 98405
        • Withdrawn
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  • Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease.

  • Has provided acceptable core or excisional biopsy obtained prior to CRT:

    • PD-L1 positive tumor status
    • If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Has adequate organ function.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible.
  • Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer. Has more than one primary HNSCC tumor.
  • Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms [DRESS] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
  • Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization.
  • Has any history of interstitial lung disease or pneumonitis (past or current).
  • Has cirrhosis of any stage or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
  • Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator.
  • Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention.
  • Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor [e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137]
  • Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
  • Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm B: Placebo
Drug: Placebo
Placebo will be administered as an IV infusion
Experimental: Arm A: Dostarlimab
Drug: Dostarlimab
Dostarlimab will be administered as an intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 5 years
Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed >20 weeks after completion of Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from date of randomization to the date of death by any cause.
Up to approximately 5 years
Event-free Survival (EFS) assessed by investigator
Time Frame: Up to approximately 5 years
Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event as per primary endpoint, however with investigator assessment per RECIST 1.1
Up to approximately 5 years
Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Serum Concentration of Dostarlimab
Time Frame: Up to approximately 15 months
Up to approximately 15 months
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Time Frame: Up to approximately 15 months
Up to approximately 15 months
Serum Predose trough concentration (Ctrough) of Dostarlimab
Time Frame: Up to approximately 15 months
Up to approximately 15 months
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Time Frame: Up to approximately 15 months
Up to approximately 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

October 26, 2029

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221530
  • 2023-508613-17 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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