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

February 5, 2024 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 HNSCC (Head and Neck Squamous Cell Carcinoma)

Study Overview

Status

Not yet 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
      • Ciudad Autonoma de Buenos Aires, Argentina, C1437GZT
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dante Pascual Goy
      • Cordoba, Argentina, 5000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Emilio Salinas
      • San Juan, Argentina, J5400
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Manuel Puig
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1417DTN
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raul Giglio
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1426
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Sebastian Fuentes
    • Río Negro
      • Viedma, Río Negro, Argentina, R8500ACE
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rubn Dario Kowalyszyn
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2002
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herman Perroud
    • Tucumán
      • San Miguel de Tucumán, Tucumán, Argentina, T4000GTB
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Felipe Salvador Palazzo
  • Australia
      • Douglas, Australia, 4814
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shivanshan Pathmanathan
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosemary Habib
    • Queensland
      • Herston, Queensland, Australia, 4029
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michelle Katherine Nottage
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen John Brown
      • Geelong, Victoria, Australia, 3220
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Madhu Sudan Singh
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
        • Principal Investigator:
          • Andrew Haydon
        • Contact:
        • Contact:
  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Pascal Machiels
      • Charleroi, Belgium, 6000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aurelie Louvet
      • Edegem, Belgium, 2650
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marika Rasschaert
      • Gent, Belgium, 9000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Saerens
      • Yvoir, Belgium, 5530
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stéphanie Henry
  • Brazil
      • São Paulo, Brazil, 01246-000
        • GSK Investigational Site
        • Principal Investigator:
          • Gilberto de Castro Junior
        • Contact:
        • Contact:
    • Bahía
      • Salvador, Bahía, Brazil, 41825-010
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dalvaro Oliveira de Castro Junior
      • Salvador, Bahía, Brazil, 41253-190
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Livia Maria Andrade
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Glaucio Antonio Bertollo
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-022
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elisa Fontes Ramos
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernanda Ramos
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88020-210
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabricio Pontes Grando
      • Joinville, Santa Catarina, Brazil, 89201-260
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Celio Kussumoto
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Pinto
      • Sao Jose Do Rio Preto, São Paulo, Brazil, 15090-200
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luiza Ferreira
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Baskoro Kartolo
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Spreafico
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Khashayar Esfahani
  • Czechia
      • Prague, Czechia, 10034
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renata Soumarova
      • Praha, Czechia, 150 08
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michaela Jirkovska
      • Praha 8, Czechia, 180 81
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petra Holeckova
      • Zlin, Czechia, 76275
        • GSK Investigational Site
        • Principal Investigator:
          • Marketa Pospiskova
        • Contact:
        • Contact:
  • France
      • Caen Cedex 5, France, 14075
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emeline Guiard
      • Dijon Cedex, France, 21079
        • GSK Investigational Site
        • Principal Investigator:
          • Sylvie Zanetta
        • Contact:
        • Contact:
      • Marseille, France, 13005
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastien Salas
      • Poitiers cedex, France, 86021
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Camille Evrard
      • Rennes Cedex, France, 35042
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florian Estrade
      • Valenciennes, France, 59300
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaovi Eric Amela
      • Vandœuvre-lès-Nancy Cedex, France, 54519
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie-Christine Kaminsky
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcus Beck
      • Berlin, Germany, 12351
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maike de Wit
      • Hamburg, Germany, 22087
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Ebeling
    • Baden-Wuerttemberg
      • Stuttgart, Baden-Wuerttemberg, Germany, 70174
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dennis Hahn
    • Bayern
      • Augsburg, Bayern, Germany, 86156
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Johannes Doescher
      • Erlangen, Bayern, Germany, 91054
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rainer Fietkau
      • Straubing, Bayern, Germany, 94315
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoniu-Oreste Gostian
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
        • Principal Investigator:
          • Philipp Ivanyi
        • Contact:
        • Contact:
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Gauler
  • Greece
      • Athens, Greece, 12462
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda Psyrri
      • Efkarpia, Greece, 564 29
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofia Baka
      • Larissa, Greece, 41100
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Athanasios Kotsakis
  • Hungary
      • Győr, Hungary, 9023
        • GSK Investigational Site
        • Principal Investigator:
          • István Sipőcz
        • Contact:
        • Contact:
      • Kaposvar, Hungary, 7400
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Éva Somogyiné Ezer
      • Nyíregyháza, Hungary, H-4400
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ágnes Wéber
      • Salgótarján, Hungary, 3100
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abdulfatah Bishr
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Perri
    • Lazio
      • Roma, Lazio, Italy, 00168
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandra Cassano
      • Roma, Lazio, Italy, 00161
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Botticelli
    • Liguria
      • Savona, Liguria, Italy, 17100
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Benasso
    • Lombardia
      • Milano, Lombardia, Italy, 20133
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Licitra
      • Milano, Lombardia, Italy, 20141
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franco Nole
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilaria Imarisio
      • Rozzano (MI), Lombardia, Italy, 20089
        • GSK Investigational Site
        • Principal Investigator:
          • Paolo Bossi
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 464-8681
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuhiro Hanai
      • Chiba, Japan, 277-8577
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Makoto Tahara
      • Chiba, Japan, 260-8717
        • GSK Investigational Site
        • Principal Investigator:
          • Takashi Kinoshita
        • Contact:
        • Contact:
      • Ehime, Japan, 791-0280
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuya Monden
      • Fukuoka, Japan, 812-8582
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mioko Matsuo
      • Hokkaido, Japan, 060-8648
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satoshi Kano
      • Hyogo, Japan, 650-0017
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naomi Kiyota
      • Iwate, Japan, 028-3695
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kiyoto Shiga
      • Kanagawa, Japan, 236-0004
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuhiko Oridate
      • Kyoto, Japan, 612-8555
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryo Asato
      • Miyagi, Japan, 981-1293
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazue Ito
      • Niigata, Japan, 951-8520
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yushi Ueki
      • Osaka, Japan, 541-8567
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Fujii
      • Saitama, Japan, 350-1298
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoko Yamazaki
      • Shizuoka, Japan, 411-8777
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoya Yokota
      • Tokyo, Japan, 104-0045
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshitaka Honma
      • Tokyo, Japan, 160-0023
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kiyoaki Tsukahara
      • Tokyo, Japan, 113-8519
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sadakatsu Ikeda
      • Tokyo, Japan, 152-8902
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shujiro Minami
      • Tottori, Japan, 683-8504
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazunori Fujiwara
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • GSK Investigational Site
        • Principal Investigator:
          • Young Jin Choi
        • Contact:
        • Contact:
      • Busan, Korea, Republic of, 602-030
        • GSK Investigational Site
        • Principal Investigator:
          • Seong-Hoon Shin
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 06351
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Myung-Ju Ahn
      • Seoul, Korea, Republic of, 110 744
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bhumsuk Keam
      • Seoul, Korea, Republic of, 03722
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye Ryun Kim
      • Suwon, Korea, Republic of, 16247
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ho Jung An
  • Mexico
      • Ciudad de Mexico, Mexico, 06760
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raul Rogelio Trejo-Rosales
      • Ciudad de Mexico, Mexico, 11510
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eduardo Cardenas-Cardenas
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gilberto Lopez-Rosas
    • Oaxaca
      • Oaxaca de Juarez, Oaxaca, Mexico, 68020
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Ivan Romero-Diaz
  • Norway
      • Bergen, Norway, 5021
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Silje Haukedal
      • Oslo, Norway, 0379
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Åse Bratland
      • Tromsø, Norway, 9038
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Kilvær
  • Poland
      • Bielsko-Biala, Poland, 43-300
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maciej Pysz
      • Gliwice, Poland, 44-102
        • GSK Investigational Site
        • Principal Investigator:
          • Tomasz Rutkowski
        • Contact:
        • Contact:
      • Katowice, Poland, 40-514
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacek Kabut
      • Koszalin, Poland, 75-581
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mariusz Kwiatkowski
      • Olsztyn, Poland, 10-228
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Janusz Kocik
      • Przemysl, Poland, 37-700
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kamil Kuc
      • Siedlce, Poland, 08-110
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lubomir Bodnar
      • Warszawa, Poland, 04-141
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Szymon Borowiec
  • Portugal
      • Coimbra, Portugal, 3000-075
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Margarida Teixeira
      • Faro, Portugal, 8000-386
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joana Magalhães
      • Lisboa, Portugal, 1649-035
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leonor Ribeiro
      • Lisboa, Portugal, 1998-018
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diogo Alpuim Costa
      • Matosinhos, Portugal, 4464-509
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matilde Salgado
      • Porto, Portugal, 4200-319
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucia Aguas
      • Porto, Portugal, 4200-072
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudia Vieira
      • Vila Nova de Gaia, Portugal, 4434-502
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Raquel Monteiro
  • Romania
      • Bucuresti, Romania, 013823
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Iordan
      • Cluj-Napoca, Romania, 400015
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alina Simona Muntean
      • Craiova, Romania, 200542
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Schenker
      • Craiova, Romania, 200094
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Visan
      • Iasi, Romania, 700483
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vlad Adrian Afrasanie
      • Oradea, Romania, 410469
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amalia Hora
      • Suceava, Romania, 720214
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Doina Elena Ganea
      • Timisoara, Romania, 300239
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra Flavia Kovacs
    • Arges
      • Pitesti, Arges, Romania, 110283
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adela-Luiza Chirila
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hedda Haugen Cange
      • Stockholm, Sweden, SE-171 64
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanna Carstens
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valentina Mouratidou
  • Taiwan
      • Changhua, Taiwan, 500
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin-Ching Lin
      • Kaohsiung, Taiwan, 833
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shau-Hsuan Li
      • Taichung, Taiwan, 40447
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ching-Yun Hsieh
      • Taipei, Taiwan, 100
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Huai-Cheng Huang
  • Turkey
      • Ankara, Turkey, 06100
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sercan Aksoy
      • Antalya, Turkey, 07025
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mustafa Ozdogan
      • Istanbul, Turkey, 34662
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faysal Dane
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Noble
      • London, United Kingdom, SW3 6JJ
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ben O'Leary
      • Nottingham,, United Kingdom, NG5 1PB
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Judith Christian
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ben O'Leary
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mano Joseph
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deborah Jean Lee Wong
      • Stockton, California, United States, 95204
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dheeraj Kodali
    • Connecticut
      • Farmington, Connecticut, United States, 06030-1628
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Upendra Hegde
      • New Haven, Connecticut, United States, 06520
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Barbara Burtness
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irina G Veytsman
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • GSK Investigational Site
        • Principal Investigator:
          • Susanne M. Arnold
        • Contact:
        • Contact:
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655-0002
        • GSK Investigational Site
        • Principal Investigator:
          • William V Walsh
        • Contact:
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Douglas Adkins
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Kaczmar
      • Greenville, South Carolina, United States, 29607
        • GSK Investigational Site
        • Principal Investigator:
          • Robert D Siegel
        • Contact:
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • G. Gary Tian

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 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 tissue demonstrating:

    • PD-L1 positive tumor status
    • If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 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, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
  • 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 undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrolment.
  • Has any history of interstitial lung disease or pneumonitis (past or current).
  • Has cirrhosis 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, CD134).
  • 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 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

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 (Estimated)

March 4, 2024

Primary Completion (Estimated)

June 9, 2028

Study Completion (Estimated)

July 13, 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)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221530
  • 2023-508613-17-00 (Other 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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