LiGeR-HN phase III trials of petosemtamab + pembrolizumab and petosemtamab monotherapy in recurrent or metastatic HNSCC.
Jean-Pascal Machiels, Jérôme Fayette, Robert Haddad...
https://pubmed.ncbi.nlm.nih.gov/40511820Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06525220
A Phase 3 Randomized, Open-label Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma
Led by Merus B.V. · Updated on 2026-06-02
700
Participants Needed
205
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3 randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-(L)1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.
CONDITIONS
Brief Title
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before any study procedures
- Age 18 years or older at signing of consent
- Histologically confirmed head and neck squamous cell carcinoma with metastatic or locally recurrent disease not suitable for curative local therapy
- Primary tumor located in oropharynx, oral cavity, hypopharynx, or larynx
- Tumors expressing PD-L1 with a combined positive score of 1 or higher
- No previous systemic therapy in the incurable recurrent or metastatic setting
- Available new tumor biopsy or sufficient archival tumor sample
- Measurable disease by radiologic methods according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Left ventricular ejection fraction of 50% or higher by echocardiogram or MUGA scan
- Adequate organ function as defined by the protocol
- HIV-positive patients eligible if CD4+ count is 300/μl or higher, viral load undetectable, and receiving antiretroviral therapy
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases or those requiring recent radiation, surgery, or steroids within 21 days before randomization
- Known leptomeningeal involvement
- Systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives before randomization
- Requirement for immunosuppressive medication
- Major surgery or radiotherapy within 3 weeks of randomization
- Significant toxicities from prior anticancer therapies not recovered to Grade 1 or baseline except certain mild conditions
- History of hypersensitivity to petosemtamab or pembrolizumab excipients
- Unstable angina, serious heart failure, arrhythmia requiring treatment, or recent myocardial infarction within 6 months
- Prior malignancies in last 5 years except excised local cancer
- Dyspnea at rest or diseases requiring continuous oxygen therapy
- Serious illnesses including uncontrolled infection or significant pulmonary, metabolic, or psychiatric disorders
- Known infectious diseases as per protocol
- Pregnant or breastfeeding patients
- Diagnosed immunodeficiency or chronic systemic steroid or immunosuppressive therapy
- Active autoimmune disease requiring systemic immune suppressive treatment in past 2 years
- History of allogeneic tissue or solid organ transplant
- Primary tumor site of nasopharynx or sinonasal carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 2 years
Participants receive either petosemtamab plus pembrolizumab combination therapy or pembrolizumab monotherapy as first-line treatment for recurrent or metastatic PD-L1+ head and neck cancer.
Regular visits throughout treatment for drug administration and assessments
Follow-up
Duration - Up to approximately 3 years
Participants are monitored after treatment ends to assess overall survival, safety, and patient-reported outcomes.
Periodic visits after treatment completion for up to 3 years
Trial Site Locations
Total: 205 locations
1
Site 164
Mobile, Alabama, United States, 36607
Actively Recruiting
2
Site 36
La Jolla, California, United States, 92037
Actively Recruiting
3
Site 27
Los Angeles, California, United States, 90033
Actively Recruiting
4
Site 16
Palo Alto, California, United States, 94304
Actively Recruiting
5
Site 19
Newark, Delaware, United States, 19713
Actively Recruiting
6
Site 108
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Site 14
Fort Myers, Florida, United States, 33901
Actively Recruiting
8
Site 48
Orlando, Florida, United States, 32804
Withdrawn
9
Site 8
Orlando, Florida, United States, 32827
Actively Recruiting
10
Site 21
St. Petersburg, Florida, United States, 33705
Actively Recruiting
11
Site 20
West Palm Beach, Florida, United States, 33401
Actively Recruiting
12
Site 171
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Site 197
Chicago, Illinois, United States, 60611
Actively Recruiting
14
Site 50
Chicago, Illinois, United States, 60637
Actively Recruiting
15
Site 2
Louisville, Kentucky, United States, 40202
Actively Recruiting
16
Site 162
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
17
Site 155
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
18
Site 168
St Louis, Missouri, United States, 63108
Actively Recruiting
19
Site 94
Hackensack, New Jersey, United States, 07601
Actively Recruiting
20
Site 6
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
21
Site 113
Durham, North Carolina, United States, 27710
Actively Recruiting
22
Site 118
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
23
Site 191
Cleveland, Ohio, United States, 44195
Actively Recruiting
24
Site 43
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Site 153
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
26
Site 154
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
27
Site 89
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
28
Site 115
Memphis, Tennessee, United States, 38103
Actively Recruiting
29
Site 88
Nashville, Tennessee, United States, 37203
Actively Recruiting
30
Site 22
Austin, Texas, United States, 78745
Actively Recruiting
31
Site 1
Houston, Texas, United States, 77030
Actively Recruiting
32
Site 18
Plano, Texas, United States, 75075
Actively Recruiting
33
Site 17
Sugar Land, Texas, United States, 77479
Actively Recruiting
34
Site 15
Tyler, Texas, United States, 75702
Actively Recruiting
35
Site 10
Salt Lake City, Utah, United States, 84112
Actively Recruiting
36
Site 12
Blacksburg, Virginia, United States, 24060
Actively Recruiting
37
Site 23
Norfolk, Virginia, United States, 23502
Actively Recruiting
38
Site 170
CABA, Argentina, C1113AAE
Actively Recruiting
39
Site 96
CABA, Argentina, C1118AAT
Actively Recruiting
40
Site 37
CABA, Argentina, C1125ABD
Withdrawn
41
Site 31
Córdoba, Argentina, X5008HHW
Actively Recruiting
42
Site 30
La Rioja, Argentina, 5300
Actively Recruiting
43
Site 76
Rosario, Argentina, S2000KZE
Actively Recruiting
44
Site 46
Viedma, Argentina, R8500ACE
Actively Recruiting
45
Site 11
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
46
Site 24
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
47
Site 166
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
48
Site 151
Melbourne, Victoria, Australia, 3004
Actively Recruiting
49
Site 53
Brussels, Belgium, 1200
Actively Recruiting
50
Site 98
Edegem, Belgium, 2650
Actively Recruiting
51
Site 99
Ghent, Belgium, 9000
Actively Recruiting
52
Site 71
Leuven, Belgium, 3000
Actively Recruiting
53
Site 109
Liège, Belgium, 4000
Actively Recruiting
54
Site 63
Namur, Belgium, 5000
Actively Recruiting
55
Site 141
Belo Horizonte, Brazil, 30.360-680
Actively Recruiting
56
Site 144
Natal, Brazil, 59020-340
Actively Recruiting
57
Site 140
Porto Alegre, Brazil, 90610-000
Actively Recruiting
58
Site 142
Porto Alegre, Brazil, 91350-200
Actively Recruiting
59
Site 137
Recife, Brazil, 50040-000
Actively Recruiting
60
Site 149
Rio de Janeiro, Brazil, 22.250-905
Actively Recruiting
61
Site 138
Rio de Janeiro, Brazil, 22281-100
Actively Recruiting
62
Site 134
São Paulo, Brazil, 01509-900
Actively Recruiting
63
Site 136
São Paulo, Brazil, 04538-132
Actively Recruiting
64
Site 165
St. John's, Canada, A1B3V6
Actively Recruiting
65
Site 44
Toronto, Canada, M5G 2M9
Actively Recruiting
66
Site 111
Winnipeg, Canada, R3E0V9
Actively Recruiting
67
Site 38
Antofagasta, Chile, 1263521
Actively Recruiting
68
Site 26
Providencia, Chile, 7500859
Actively Recruiting
69
Site 29
Recoleta, Chile, 8420000
Actively Recruiting
70
Site 40
Santiago, Chile, 7500921
Actively Recruiting
71
Site 32
Santiago, Chile, 7560908
Actively Recruiting
72
Site 34
Santiago, Chile, 8330336
Actively Recruiting
73
Site 25
Temuco, Chile, 76281055-7
Actively Recruiting
74
Site 205
Osijek, Croatia, 31000
Actively Recruiting
75
Site 199
Split, Croatia, 21000
Actively Recruiting
76
Site 204
Zagreb, Croatia, 10000
Actively Recruiting
77
Site 195
Olomouc, Czechia, 779 00
Actively Recruiting
78
Site 192
Prague, Czechia, 150 06
Actively Recruiting
79
Site 56
Bordeaux, France, 33075
Actively Recruiting
80
Site 101
Le Mans, France, 72000
Actively Recruiting
81
Site 79
Lille, France, 59000
Actively Recruiting
82
Site 72
Lyon, France, 69378
Actively Recruiting
83
Site 57
Marseille, France, 13005
Actively Recruiting
84
Site 55
Montpellier, France, 34298
Actively Recruiting
85
Site 66
Nice, France, 06189
Actively Recruiting
86
Site 105
Paris, France, 75005
Actively Recruiting
87
Site 143
Paris, France, 75013
Actively Recruiting
88
Site 87
Poitiers, France, 86021
Actively Recruiting
89
Site 54
Rouen, France, 76038
Actively Recruiting
90
Site 59
Toulouse, France, 31100
Actively Recruiting
91
Site 64
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
92
Site 112
Villejuif, France, 94800
Actively Recruiting
93
Site 133
Bonn, Germany, 53175
Actively Recruiting
94
Site 178
Dortmund, Germany, 44137
Actively Recruiting
95
Site 100
Dresden, Germany, 01307
Actively Recruiting
96
Site 60
Greifswald, Germany, 17475
Actively Recruiting
97
Site 82
Hamburg, Germany, 20251
Actively Recruiting
98
Site 91
Hamburg, Germany, 22763
Actively Recruiting
99
Site 104
Hanover, Germany, 30625
Actively Recruiting
100
Site 129
Mannheim, Germany, 68167
Actively Recruiting
101
Site 148
München, Germany, 81675
Actively Recruiting
102
Site 121
Münster, Germany, 48149
Actively Recruiting
103
Site 78
Tübingen, Germany, 72076
Actively Recruiting
104
Site 130
Ulm, Germany, 89075
Actively Recruiting
105
Site 110
Würzburg, Germany, 97080
Actively Recruiting
106
Site 119
Pátrai, Achaia, Greece, 265 04
Actively Recruiting
107
Site 156
Athens, Attica, Greece, 151 23
Actively Recruiting
108
Site 117
Heraklion, Crete, Greece, 715 00
Actively Recruiting
109
Site 95
Chaïdári, Greece, 12462
Actively Recruiting
110
Site 92
Panórama, Greece, 55236
Actively Recruiting
111
Site 194
Nyíregyháza, Hungary, 4400
Actively Recruiting
112
Site 189
Pécs, Hungary, 7624
Actively Recruiting
113
Site 187
Szeged, Hungary, 6720
Actively Recruiting
114
Site 9
Haifa, Israel, 3109601
Actively Recruiting
115
Site 5
Jerusalem, Israel, 9112001
Actively Recruiting
116
Site 3
Ramat Gan, Israel, 5266202
Actively Recruiting
117
Site 7
Tel Aviv, Israel, 6423906
Actively Recruiting
118
Site 86
Ancona, Italy, 60126
Actively Recruiting
119
Site 97
Brescia, Italy, 25123
Actively Recruiting
120
Site 180
Cagliari, Italy, 09121
Actively Recruiting
121
Site 139
Meldola, Italy, 47014
Actively Recruiting
122
Site 122
Milan, Italy, 20133
Actively Recruiting
123
Site 81
Milan, Italy, 20141
Actively Recruiting
124
Site 152
Naples, Italy, 80131
Actively Recruiting
125
Site 93
Naples, Italy, 80131
Actively Recruiting
126
Site 186
Rome, Italy, 00161
Actively Recruiting
127
Site 85
Rozzano, Italy, 20089
Actively Recruiting
128
Site 167
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
129
Site 123
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
130
Site 185
Fukuoka, Fukuoka, Japan, 810-8563
Actively Recruiting
131
Site 127
Hiragi, Kagawa-ken, Japan, 761-0793
Actively Recruiting
132
Site 174
Natori-shi, Miyagi, Japan, 981-1293
Actively Recruiting
133
Site 126
Sendai, Miyagi, Japan, 960-8574
Actively Recruiting
134
Site 125
Ōsaka-sayama, Osaka, Japan, 589-8511
Actively Recruiting
135
Site 124
Chuo Ku, Tokyo, Japan, 104-0045
Actively Recruiting
136
Site 188
Minato-Ku, Tokyo, Japan, 105-8471
Actively Recruiting
137
Site 183
Kaunas, Lithuania, 50161
Actively Recruiting
138
Site 179
Vilnius, Lithuania, 08406
Actively Recruiting
139
Site 163
Johor Bahru, Malaysia, 81100
Actively Recruiting
140
Site 159
Kuching, Malaysia, 93586
Actively Recruiting
141
Site 161
Putrajaya, Malaysia, 62250
Actively Recruiting
142
Site 201
Chihuahua City, Mexico, 31000
Actively Recruiting
143
Site 200
Guadalajara, Mexico, 44680
Actively Recruiting
144
Site 202
Mexico City, Mexico, 06100
Actively Recruiting
145
Site 84
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
146
Site 58
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
147
Site 68
Utrecht, Netherlands, 3584 CX
Actively Recruiting
148
Site 150
Bydgoszcz, Poland, 85-796
Actively Recruiting
149
Site 131
Gdansk, Poland, 80-214
Actively Recruiting
150
Site 106
Gliwice, Poland, 44-102
Actively Recruiting
151
Site 116
Krakow, Poland, 31-826
Actively Recruiting
152
Site 190
Lodz, Poland, 93-513
Actively Recruiting
153
Site 158
Warsaw, Poland, 02-781
Actively Recruiting
154
Site 172
Coimbra, Portugal, 3004-561
Actively Recruiting
155
Site 182
Lisbon, Portugal, 1998-018
Actively Recruiting
156
Site 181
Portimão, Portugal, 8500-338
Actively Recruiting
157
Site 175
Porto, Portugal, 4200-072
Actively Recruiting
158
Site 203
Vila Real, Portugal, 5000-508
Actively Recruiting
159
Site 145
Busan, South Korea, 48108
Actively Recruiting
160
Site 13
Goyang-si, South Korea, 10408
Actively Recruiting
161
Site 47
Gyeonggi-do, South Korea, 13496
Withdrawn
162
Site 51
Hwasun, South Korea, 58128
Actively Recruiting
163
Site 28
Seoul, South Korea, 03722
Actively Recruiting
164
Site 35
Seoul, South Korea, 03722
Actively Recruiting
165
Site 45
Seoul, South Korea, 05505
Actively Recruiting
166
Site 42
Suwon, South Korea, 16247
Actively Recruiting
167
Site 157
Suwon, South Korea, 16499
Actively Recruiting
168
Site 120
Badalona, Spain, 08916
Actively Recruiting
169
Site 80
Barcelona, Spain, 08035
Actively Recruiting
170
Site 128
Madrid, Spain, 28040
Actively Recruiting
171
Site 75
Madrid, Spain, 28040
Actively Recruiting
172
Site 67
Madrid, Spain, 28041
Actively Recruiting
173
Site 160
Madrid, Spain, 28050
Actively Recruiting
174
Site 73
Marbella, Spain, 29660
Actively Recruiting
175
Site 61
Pamplona, Spain, 31008
Actively Recruiting
176
Site 62
Pamplona, Spain, 31008
Actively Recruiting
177
Site 74
Valencia, Spain, 46009
Actively Recruiting
178
Site 41
Changhua, Taiwan, 500
Actively Recruiting
179
Site 4
Kaohsiung City, Taiwan, 80756
Actively Recruiting
180
Site 103
Kaohsiung City, Taiwan, 833
Actively Recruiting
181
Site 52
Taichung, Taiwan, 40447
Actively Recruiting
182
Site 39
Taipei, Taiwan, 100
Actively Recruiting
183
Site 33
Taipei, Taiwan, 112
Actively Recruiting
184
Site 49
Taoyuan City, Taiwan, 333
Actively Recruiting
185
Site 114
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
186
Site 107
Pathum Wan, Bangkok, Thailand, 10330
Actively Recruiting
187
Site 65
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
188
Site 77
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
189
Site 146
Chiang Rai, Thailand, 57000
Actively Recruiting
190
Site 196
Ankara, Turkey (Türkiye), 06170
Actively Recruiting
191
Site 184
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
192
Site 176
Antalya, Turkey (Türkiye), 07025
Actively Recruiting
193
Site 198
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
194
Site 193
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
195
Site 102
Cambridge, United Kingdom, CB20QQ
Actively Recruiting
196
Site 169
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
197
Site 132
London, United Kingdom, EC1A 7BE
Actively Recruiting
198
Site 90
London, United Kingdom, SE19RT
Actively Recruiting
199
Site 69
London, United Kingdom, SW3 6JJ
Actively Recruiting
200
Site 173
Manchester, United Kingdom, M20 4BX
Actively Recruiting
201
Site 177
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
202
Site 83
Northwood, United Kingdom, HA62RN
Actively Recruiting
203
Site 147
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
204
Site 70
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
205
Site 135
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
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Research Team
H
Head of Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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