Actively Recruiting
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Led by GlaxoSmithKline · Updated on 2025-09-25
864
Participants Needed
240
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has newly diagnosed unresected locally advanced HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx
- Completed cisplatin plus radiotherapy with curative intent and no distant metastatic disease
- Provided acceptable core or excisional biopsy prior to chemoradiation
- PD-L1 positive tumor status
- For oropharyngeal carcinoma, p16 immunohistochemistry testing is required
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Prior radiation therapy, systemic therapy, targeted therapy, or surgery for head and neck cancer other than cisplatin plus radiotherapy chemoradiation
- Received induction chemotherapy
- Chemoradiation combinations with agents other than cisplatin and radiotherapy (e.g., experimental agents, cetuximab)
- Cancer outside oral cavity, oropharynx, hypopharynx, or larynx, including nasopharyngeal, sinus, para-nasal, or unknown primary
- More than one primary HNSCC tumor
- History of severe immune-related adverse events or severe neurologic immune events from prior immunotherapy
- History of exfoliative dermatitis or myocarditis
- Major unresolved surgical procedure or traumatic injury at randomization
- History or current interstitial lung disease or pneumonitis
- Cirrhosis or unstable liver biliary disease
- Medical conditions or abnormalities interfering with study participation
- Receiving any other anticancer or experimental therapies
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or other T-cell receptor agents
- Pregnant, breastfeeding, or planning pregnancy during study and 120 days after last dose
- History of severe allergic or anaphylactic reactions to antibodies or known allergies to dostarlimab or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 240 locations
1
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
GSK Investigational Site
Los Angeles, California, United States, 90095
Actively Recruiting
3
GSK Investigational Site
Solvang, California, United States, 93463
Actively Recruiting
4
GSK Investigational Site
Stockton, California, United States, 95204
Actively Recruiting
5
GSK Investigational Site
Torrance, California, United States, 90505
Actively Recruiting
6
GSK Investigational Site
Farmington, Connecticut, United States, 06030-1628
Actively Recruiting
7
GSK Investigational Site
New Haven, Connecticut, United States, 06520
Actively Recruiting
8
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20010
Withdrawn
9
GSK Investigational Site
St. Petersburg, Florida, United States, 33709
Actively Recruiting
10
GSK Investigational Site
Tamarac, Florida, United States, 33321
Actively Recruiting
11
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
12
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
13
GSK Investigational Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
GSK Investigational Site
Lexington, Kentucky, United States, 40536
Actively Recruiting
15
GSK Investigational Site
Columbia, Maryland, United States, 21044
Actively Recruiting
16
GSK Investigational Site
Worcester, Massachusetts, United States, 01655-0002
Actively Recruiting
17
GSK Investigational Site
St Louis, Missouri, United States, 63110
Actively Recruiting
18
GSK Investigational Site
Omaha, Nebraska, United States, 68114
Actively Recruiting
19
GSK Investigational Site
New York, New York, United States, 10032
Completed
20
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Actively Recruiting
21
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
22
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Actively Recruiting
23
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
24
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Actively Recruiting
25
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Actively Recruiting
27
GSK Investigational Site
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
28
GSK Investigational Site
Wytheville, Virginia, United States, 24382
Actively Recruiting
29
GSK Investigational Site
Tacoma, Washington, United States, 98405
Withdrawn
30
GSK Investigational Site
Buenos Aires, Argentina, 1023
Actively Recruiting
31
GSK Investigational Site
Buenos Aires, Argentina, C1425
Actively Recruiting
32
GSK Investigational Site
Buenos Aires, Argentina, C1437GZT
Actively Recruiting
33
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1426
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34
GSK Investigational Site
Córdoba, Argentina, 5000
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35
GSK Investigational Site
Rosario, Argentina, S2002
Actively Recruiting
36
GSK Investigational Site
San Juan, Argentina, J5400
Actively Recruiting
37
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000GTB
Actively Recruiting
38
GSK Investigational Site
Viedma, Argentina, R8500ACE
Actively Recruiting
39
GSK Investigational Site
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
40
GSK Investigational Site
Douglas, Queensland, Australia, 4814
Actively Recruiting
41
GSK Investigational Site
Herston, Queensland, Australia, 4029
Withdrawn
42
GSK Investigational Site
Ballarat, Victoria, Australia, 3350
Actively Recruiting
43
GSK Investigational Site
Geelong, Victoria, Australia, 3220
Actively Recruiting
44
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
45
GSK Investigational Site
Brussels, Belgium, 1200
Actively Recruiting
46
GSK Investigational Site
Charleroi, Belgium, 6060
Actively Recruiting
47
GSK Investigational Site
Edegem, Belgium, 2650
Actively Recruiting
48
GSK Investigational Site
Ghent, Belgium, 9000
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49
GSK Investigational Site
Yvoir, Belgium, 5530
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50
GSK Investigational Site
Barretos, Brazil, 14784-400
Actively Recruiting
51
GSK Investigational Site
Belo Horizonte, Brazil, 30110-022
Actively Recruiting
52
GSK Investigational Site
Florianópolis, Brazil, 88020-210
Actively Recruiting
53
GSK Investigational Site
Ijuí, Brazil, 98700-000
Actively Recruiting
54
GSK Investigational Site
Jaú, Brazil, 17210-120
Actively Recruiting
55
GSK Investigational Site
Joinville, Brazil, 89201-260
Actively Recruiting
56
GSK Investigational Site
Natal, Brazil, 59075-740
Actively Recruiting
57
GSK Investigational Site
Porto Alegre, Brazil, 90610-000
Actively Recruiting
58
GSK Investigational Site
Salvador, Brazil, 41253-190
Actively Recruiting
59
GSK Investigational Site
Salvador, Brazil, 41950-640
Actively Recruiting
60
GSK Investigational Site
São José do Rio Preto, Brazil, 15090-200
Actively Recruiting
61
GSK Investigational Site
São Paulo, Brazil, 01246-000
Actively Recruiting
62
GSK Investigational Site
Vitória, Brazil, 29043-260
Actively Recruiting
63
GSK Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
64
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
65
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Completed
66
GSK Investigational Site
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
67
GSK Investigational Site
Beijing, China, 100036
Actively Recruiting
68
GSK Investigational Site
Changsha, China, 410013
Actively Recruiting
69
GSK Investigational Site
Changzhou, China, 213032
Actively Recruiting
70
GSK Investigational Site
Chengdu, China, 610000
Actively Recruiting
71
GSK Investigational Site
Chengdu, China, 610041
Actively Recruiting
72
GSK Investigational Site
Dongguan, China, 523059
Actively Recruiting
73
GSK Investigational Site
Fuzhou, China, 350005
Actively Recruiting
74
GSK Investigational Site
Fuzhou, China, 350014
Actively Recruiting
75
GSK Investigational Site
Guangzhou, China, 510503
Actively Recruiting
76
GSK Investigational Site
Hangzhou, China, 310003
Actively Recruiting
77
GSK Investigational Site
Hangzhou, China, 310022
Actively Recruiting
78
GSK Investigational Site
Hefei, China, 230001
Actively Recruiting
79
GSK Investigational Site
Hengyang, China, 421000
Actively Recruiting
80
GSK Investigational Site
Jinan, China, 250117
Actively Recruiting
81
GSK Investigational Site
Linyi, China, 276002
Actively Recruiting
82
GSK Investigational Site
Nanchang, China, 330006
Actively Recruiting
83
GSK Investigational Site
Nanchang, China, 330029
Actively Recruiting
84
GSK Investigational Site
Nanning, China, 530021
Actively Recruiting
85
GSK Investigational Site
Shanghai, China, 200032
Actively Recruiting
86
GSK Investigational Site
Taiyuan, China, 030013
Actively Recruiting
87
GSK Investigational Site
Wuhan, China, 430030
Actively Recruiting
88
GSK Investigational Site
Wuhan, China, 430079
Actively Recruiting
89
GSK Investigational Site
Xiamen, China, 361004
Actively Recruiting
90
GSK Investigational Site
Zhengzhou, China, 450052
Actively Recruiting
91
GSK Investigational Site
Zhuhai, China, 519001
Actively Recruiting
92
GSK Investigational Site
Olomouc, Czechia, 779 00
Actively Recruiting
93
GSK Investigational Site
Prague, Czechia, 10034
Actively Recruiting
94
GSK Investigational Site
Prague, Czechia, 150 08
Actively Recruiting
95
GSK Investigational Site
Prague, Czechia, 180 81
Actively Recruiting
96
GSK Investigational Site
Zlín, Czechia, 76275
Actively Recruiting
97
GSK Investigational Site
Caen, France, 14075
Actively Recruiting
98
GSK Investigational Site
Dijon, France, 21079
Actively Recruiting
99
GSK Investigational Site
Marseille, France, 13005
Actively Recruiting
100
GSK Investigational Site
Poitiers, France, 86021
Actively Recruiting
101
GSK Investigational Site
Quimper, France, 29000
Actively Recruiting
102
GSK Investigational Site
Rennes, France, 35042
Actively Recruiting
103
GSK Investigational Site
Rouen, France, 76038
Actively Recruiting
104
GSK Investigational Site
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
105
GSK Investigational Site
Augsburg, Germany, 86156
Actively Recruiting
106
GSK Investigational Site
Berlin, Germany, 12351
Actively Recruiting
107
GSK Investigational Site
Berlin, Germany, 13353
Actively Recruiting
108
GSK Investigational Site
Erlangen, Germany, 91054
Actively Recruiting
109
GSK Investigational Site
Essen, Germany, 45147
Actively Recruiting
110
GSK Investigational Site
Giessen, Germany, 35392
Actively Recruiting
111
GSK Investigational Site
Hamburg, Germany, 22087
Actively Recruiting
112
GSK Investigational Site
Neuruppin, Germany, 16816
Actively Recruiting
113
GSK Investigational Site
Straubing, Germany, 94315
Actively Recruiting
114
GSK Investigational Site
Athens, Greece, 115 22
Actively Recruiting
115
GSK Investigational Site
Athens, Greece, 12462
Actively Recruiting
116
GSK Investigational Site
Larissa, Greece, 41100
Actively Recruiting
117
GSK Investigational Site
Thessaloniki, Greece, 564 29
Actively Recruiting
118
GSK Investigational Site
Győr, Hungary, 9023
Actively Recruiting
119
GSK Investigational Site
Kaposvár, Hungary, 7400
Actively Recruiting
120
GSK Investigational Site
Nyíregyháza, Hungary, H-4400
Actively Recruiting
121
GSK Investigational Site
Bengaluru, India, 560066
Actively Recruiting
122
GSK Investigational Site
Bhubaneswar, India, 751019
Actively Recruiting
123
GSK Investigational Site
Hyderabad, India, 500004
Actively Recruiting
124
GSK Investigational Site
Mumbai, India, 400012
Actively Recruiting
125
GSK Investigational Site
Nashik, India, 422002
Actively Recruiting
126
GSK Investigational Site
Nehru Nagar Belagavi Karnataka 590010, India, 590010
Actively Recruiting
127
GSK Investigational Site
Surat, India, 395002
Actively Recruiting
128
GSK Investigational Site
Vijayawada, India, 520002
Actively Recruiting
129
GSK Investigational Site
Ashdod, Israel, 7747629
Actively Recruiting
130
GSK Investigational Site
Haifa, Israel, 3109601
Actively Recruiting
131
GSK Investigational Site
Jerusalem, Israel, 9112001
Actively Recruiting
132
GSK Investigational Site
Tel Aviv, Israel, 64239
Actively Recruiting
133
GSK Investigational Site
Bologna, Italy, 40139
Actively Recruiting
134
GSK Investigational Site
Milan, Italy, 20133
Actively Recruiting
135
GSK Investigational Site
Milan, Italy, 20141
Actively Recruiting
136
GSK Investigational Site
Naples, Italy, 80131
Actively Recruiting
137
GSK Investigational Site
Pavia, Italy, 27100
Actively Recruiting
138
GSK Investigational Site
Prato, Italy, 59100
Actively Recruiting
139
GSK Investigational Site
Roma, Italy, 00161
Actively Recruiting
140
GSK Investigational Site
Roma, Italy, 00168
Actively Recruiting
141
GSK Investigational Site
Rozzano MI, Italy, 20089
Actively Recruiting
142
GSK Investigational Site
Savona, Italy, 17100
Actively Recruiting
143
GSK Investigational Site
Aichi, Japan, 464-8681
Actively Recruiting
144
GSK Investigational Site
Aomori, Japan, 036-8563
Actively Recruiting
145
GSK Investigational Site
Chiba, Japan, 260-8717
Actively Recruiting
146
GSK Investigational Site
Chiba, Japan, 277-8577
Actively Recruiting
147
GSK Investigational Site
Ehime, Japan, 791-0280
Actively Recruiting
148
GSK Investigational Site
Fukuoka, Japan, 812-8582
Actively Recruiting
149
GSK Investigational Site
Gunma, Japan, 371-8511
Actively Recruiting
150
GSK Investigational Site
Hokkaido, Japan, 060-8648
Actively Recruiting
151
GSK Investigational Site
Hyōgo, Japan, 650-0017
Actively Recruiting
152
GSK Investigational Site
Hyōgo, Japan, 673-8558
Actively Recruiting
153
GSK Investigational Site
Kagoshima, Japan, 890-8520
Actively Recruiting
154
GSK Investigational Site
Kanagawa, Japan, 236-0004
Actively Recruiting
155
GSK Investigational Site
Kanagawa, Japan, 259-1193
Actively Recruiting
156
GSK Investigational Site
Kyoto, Japan, 612-8555
Actively Recruiting
157
GSK Investigational Site
Miyagi, Japan, 981-1293
Actively Recruiting
158
GSK Investigational Site
Niigata, Japan, 951-8520
Actively Recruiting
159
GSK Investigational Site
Numakunai, Japan, 028-3695
Actively Recruiting
160
GSK Investigational Site
Osaka, Japan, 541-8567
Actively Recruiting
161
GSK Investigational Site
Saitama, Japan, 350-1298
Actively Recruiting
162
GSK Investigational Site
Shizuoka, Japan, 411-8777
Actively Recruiting
163
GSK Investigational Site
Tokyo, Japan, 105-8471
Actively Recruiting
164
GSK Investigational Site
Tokyo, Japan, 113-8519
Actively Recruiting
165
GSK Investigational Site
Tokyo, Japan, 152-8902
Actively Recruiting
166
GSK Investigational Site
Tokyo, Japan, 160-0023
Actively Recruiting
167
GSK Investigational Site
Tottori, Japan, 683-8504
Actively Recruiting
168
GSK Investigational Site
Guadalajara, Mexico, 44650
Actively Recruiting
169
GSK Investigational Site
Mexico City, Mexico, 06760
Actively Recruiting
170
GSK Investigational Site
Mexico City, Mexico, 11510
Actively Recruiting
171
GSK Investigational Site
Oaxaca City, Mexico, 68020
Actively Recruiting
172
GSK Investigational Site
Bergen, Norway, 5021
Actively Recruiting
173
GSK Investigational Site
Oslo, Norway, 0379
Actively Recruiting
174
GSK Investigational Site
Troms, Norway, 9038
Actively Recruiting
175
GSK Investigational Site
Bielsko-Biala, Poland, 43-300
Actively Recruiting
176
GSK Investigational Site
Gliwice, Poland, 44-102
Actively Recruiting
177
GSK Investigational Site
Katowice, Poland, 40-514
Actively Recruiting
178
GSK Investigational Site
Olsztyn, Poland, 10-228
Actively Recruiting
179
GSK Investigational Site
Przemyśl, Poland, 37-700
Actively Recruiting
180
GSK Investigational Site
Siedlce, Poland, 08-110
Actively Recruiting
181
GSK Investigational Site
Warsaw, Poland, 04-141
Actively Recruiting
182
GSK Investigational Site
Coimbra, Portugal, 3000-075
Actively Recruiting
183
GSK Investigational Site
Faro, Portugal, 8000-386
Actively Recruiting
184
GSK Investigational Site
Lisbon, Portugal, 1649-035
Actively Recruiting
185
GSK Investigational Site
Lisbon, Portugal, 1998-018
Actively Recruiting
186
GSK Investigational Site
Matosinhos Municipality, Portugal, 4464-509
Actively Recruiting
187
GSK Investigational Site
Porto, Portugal, 4200-072
Actively Recruiting
188
GSK Investigational Site
Porto, Portugal, 4200-319
Actively Recruiting
189
GSK Investigational Site
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
190
GSK Investigational Site
Bucharest, Romania, 013823
Actively Recruiting
191
GSK Investigational Site
Bucharest, Romania, 020142
Actively Recruiting
192
GSK Investigational Site
Craiova, Romania, 200508
Actively Recruiting
193
GSK Investigational Site
Craiova, Romania, 200542
Actively Recruiting
194
GSK Investigational Site
Floreşti, Romania, 407280
Actively Recruiting
195
GSK Investigational Site
Iași, Romania, 700483
Actively Recruiting
196
GSK Investigational Site
Oradea, Romania, 410469
Actively Recruiting
197
GSK Investigational Site
Piteşti, Romania, 110283
Actively Recruiting
198
GSK Investigational Site
Suceava, Romania, 720214
Actively Recruiting
199
GSK Investigational Site
Timișoara, Romania, 300239
Actively Recruiting
200
GSK Investigational Site
Busan, South Korea, 602-030
Actively Recruiting
201
GSK Investigational Site
Pusan, South Korea, 49241
Withdrawn
202
GSK Investigational Site
Seoul, South Korea, 03722
Actively Recruiting
203
GSK Investigational Site
Seoul, South Korea, 06351
Actively Recruiting
204
GSK Investigational Site
Seoul, South Korea, 110 744
Actively Recruiting
205
GSK Investigational Site
Suwon Gyeonggi-do, South Korea, 16247
Actively Recruiting
206
GSK Investigational Site
BaracaldoVizcaya, Spain, 48903
Actively Recruiting
207
GSK Investigational Site
Barcelona, Spain, 08023
Actively Recruiting
208
GSK Investigational Site
Cartagena Murcia, Spain, 30202
Actively Recruiting
209
GSK Investigational Site
HebrOn, Spain, 08035
Actively Recruiting
210
GSK Investigational Site
Jerez de la Frontera, Spain, 11407
Actively Recruiting
211
GSK Investigational Site
L'Hospitalet de Llobrega, Spain, 08908
Actively Recruiting
212
GSK Investigational Site
Lugo, Spain, 27003
Actively Recruiting
213
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
214
GSK Investigational Site
Madrid, Spain, 28041
Actively Recruiting
215
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
216
GSK Investigational Site
Pamplona, Spain, 31008
Actively Recruiting
217
GSK Investigational Site
Salamanca, Spain, 37007
Actively Recruiting
218
GSK Investigational Site
Santander, Spain, 39008
Actively Recruiting
219
GSK Investigational Site
Zaragoza, Spain, 50009
Actively Recruiting
220
GSK Investigational Site
Gothenburg, Sweden, SE-413 45
Actively Recruiting
221
GSK Investigational Site
Stockholm, Sweden, SE-171 64
Actively Recruiting
222
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Actively Recruiting
223
GSK Investigational Site
Changhua, Taiwan, 500
Actively Recruiting
224
GSK Investigational Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
225
GSK Investigational Site
Taichung, Taiwan, 40447
Actively Recruiting
226
GSK Investigational Site
Taipei, Taiwan, 100
Actively Recruiting
227
GSK Investigational Site
Adapazarı, Turkey (Türkiye)
Actively Recruiting
228
GSK Investigational Site
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
229
GSK Investigational Site
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
230
GSK Investigational Site
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
231
GSK Investigational Site
Antalya, Turkey (Türkiye), 7050
Actively Recruiting
232
GSK Investigational Site
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
233
GSK Investigational Site
Istanbul, Turkey (Türkiye), 34662
Actively Recruiting
234
GSK Investigational Site
Istanbul, Şişli, Turkey (Türkiye), 34384
Actively Recruiting
235
GSK Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
236
GSK Investigational Site
Gloucester, United Kingdom, GL1 3NN
Actively Recruiting
237
GSK Investigational Site
London, United Kingdom, SW3 6JJ
Actively Recruiting
238
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
239
GSK Investigational Site
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
240
GSK Investigational Site
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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