Actively Recruiting
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Led by Merus B.V. · Updated on 2026-05-08
700
Participants Needed
202
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older at time of consent
- Confirmed head and neck squamous cell carcinoma (HNSCC) with metastatic or locally recurrent disease not suitable for curative local therapy
- Primary tumor located in oropharynx, oral cavity, hypopharynx, or larynx
- Eligible for pembrolizumab monotherapy with tumors expressing PD-L1, combined positive score (CPS) of 1 or higher
- No prior systemic therapy for incurable recurrent or metastatic disease
- New tumor biopsy available or archival tumor sample with enough material
- Measurable disease by radiologic methods according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks as assessed by investigator
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiogram or MUGA scan
- Adequate organ function as defined in the study 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 requiring ongoing treatment within 21 days before randomization
- Known leptomeningeal involvement
- Any systemic anticancer or investigational therapy within 4 weeks or 5 half-lives before randomization
- Need for immunosuppressive medication
- Major surgery or radiotherapy within 3 weeks before randomization
- Unresolved significant toxicities from prior cancer therapies except certain mild conditions
- History of allergy to petosemtamab or pembrolizumab components
- Unstable angina, serious heart failure, serious arrhythmia, or recent heart attack within 6 months
- Prior malignancies within 5 years except excised local cancer
- Current resting shortness of breath or need for continuous oxygen therapy
- Serious uncontrolled medical conditions including infection, lung, metabolic, or psychiatric disorders
- Known infectious diseases as specified in the protocol
- Pregnancy or breastfeeding
- Diagnosed immunodeficiency or chronic steroid or immunosuppressive therapy
- Active autoimmune disease needing systemic immune suppressive treatment within past 2 years
- History of allogeneic tissue or solid organ transplant
- Primary tumor site of nasopharynx or sinonasal carcinoma of any histology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 202 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
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12
Site 171
Atlanta, Georgia, United States, 30322
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13
Site 197
Chicago, Illinois, United States, 60611
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14
Site 50
Chicago, Illinois, United States, 60637
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15
Site 2
Louisville, Kentucky, United States, 40202
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16
Site 162
Baton Rouge, Louisiana, United States, 70809
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17
Site 155
Minneapolis, Minnesota, United States, 55417
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18
Site 168
St Louis, Missouri, United States, 63108
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19
Site 94
Hackensack, New Jersey, United States, 07601
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20
Site 6
Albuquerque, New Mexico, United States, 87131
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21
Site 113
Durham, North Carolina, United States, 27710
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22
Site 118
Winston-Salem, North Carolina, United States, 27157
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23
Site 191
Cleveland, Ohio, United States, 44195
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24
Site 43
Philadelphia, Pennsylvania, United States, 19104
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25
Site 153
Philadelphia, Pennsylvania, United States, 19107
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26
Site 154
Philadelphia, Pennsylvania, United States, 19114
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27
Site 89
Chattanooga, Tennessee, United States, 37404
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28
Site 115
Memphis, Tennessee, United States, 38103
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29
Site 88
Nashville, Tennessee, United States, 37203
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30
Site 22
Austin, Texas, United States, 78745
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31
Site 1
Houston, Texas, United States, 77030
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32
Site 18
Plano, Texas, United States, 75075
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33
Site 17
Sugar Land, Texas, United States, 77479
Actively Recruiting
34
Site 15
Tyler, Texas, United States, 75702
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35
Site 10
Salt Lake City, Utah, United States, 84112
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36
Site 12
Blacksburg, Virginia, United States, 24060
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37
Site 23
Norfolk, Virginia, United States, 23502
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38
Site 170
CABA, Argentina, C1113AAE
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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
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45
Site 11
Blacktown, New South Wales, Australia, 2148
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46
Site 24
St Leonards, New South Wales, Australia, 2065
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47
Site 166
Greenslopes, Queensland, Australia, 4120
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48
Site 151
Melbourne, Victoria, Australia, 3004
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49
Site 53
Brussels, Belgium, 1200
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50
Site 98
Edegem, Belgium, 2650
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51
Site 99
Ghent, Belgium, 9000
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52
Site 71
Leuven, Belgium, 3000
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53
Site 109
Liège, Belgium, 4000
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54
Site 63
Namur, Belgium, 5000
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55
Site 141
Belo Horizonte, Brazil, 30.360-680
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56
Site 144
Natal, Brazil, 59020-340
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57
Site 140
Porto Alegre, Brazil, 90610-000
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58
Site 142
Porto Alegre, Brazil, 91350-200
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59
Site 137
Recife, Brazil, 50040-000
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60
Site 149
Rio de Janeiro, Brazil, 22.250-905
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61
Site 138
Rio de Janeiro, Brazil, 22281-100
Actively Recruiting
62
Site 134
São Paulo, Brazil, 01509-900
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63
Site 136
São Paulo, Brazil, 04538-132
Actively Recruiting
64
Site 165
St. John's, Canada, A1B3V6
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65
Site 44
Toronto, Canada, M5G 2M9
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66
Site 111
Winnipeg, Canada, R3E0V9
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67
Site 38
Antofagasta, Chile, 1263521
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68
Site 26
Providencia, Chile, 7500859
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69
Site 29
Recoleta, Chile, 8420000
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70
Site 40
Santiago, Chile, 7500921
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71
Site 32
Santiago, Chile, 7560908
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72
Site 34
Santiago, Chile, 8330336
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73
Site 25
Temuco, Chile, 76281055-7
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74
Site 199
Split, Croatia, 21000
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75
Site 195
Olomouc, Czechia, 779 00
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76
Site 192
Prague, Czechia, 150 06
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77
Site 56
Bordeaux, France, 33075
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78
Site 101
Le Mans, France, 72000
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79
Site 79
Lille, France, 59000
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80
Site 72
Lyon, France, 69378
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81
Site 57
Marseille, France, 13005
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82
Site 55
Montpellier, France, 34298
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83
Site 66
Nice, France, 06189
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84
Site 105
Paris, France, 75005
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85
Site 143
Paris, France, 75013
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86
Site 87
Poitiers, France, 86021
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87
Site 54
Rouen, France, 76038
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88
Site 59
Toulouse, France, 31100
Actively Recruiting
89
Site 64
Vandœuvre-lès-Nancy, France, 54519
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90
Site 112
Villejuif, France, 94800
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91
Site 133
Bonn, Germany, 53175
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92
Site 178
Dortmund, Germany, 44137
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93
Site 100
Dresden, Germany, 01307
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94
Site 60
Greifswald, Germany, 17475
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95
Site 82
Hamburg, Germany, 20251
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96
Site 91
Hamburg, Germany, 22763
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97
Site 104
Hanover, Germany, 30625
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98
Site 129
Mannheim, Germany, 68167
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99
Site 148
München, Germany, 81675
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100
Site 121
Münster, Germany, 48149
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101
Site 78
Tübingen, Germany, 72076
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102
Site 130
Ulm, Germany, 89075
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103
Site 110
Würzburg, Germany, 97080
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104
Site 119
Pátrai, Achaia, Greece, 265 04
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105
Site 156
Athens, Attica, Greece, 151 23
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106
Site 117
Heraklion, Crete, Greece, 715 00
Actively Recruiting
107
Site 95
Chaïdári, Greece, 12462
Actively Recruiting
108
Site 92
Panórama, Greece, 55236
Actively Recruiting
109
Site 194
Nyíregyháza, Hungary, 4400
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110
Site 189
Pécs, Hungary, 7624
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111
Site 187
Szeged, Hungary, 6720
Actively Recruiting
112
Site 9
Haifa, Israel, 3109601
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113
Site 5
Jerusalem, Israel, 9112001
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114
Site 3
Ramat Gan, Israel, 5266202
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115
Site 7
Tel Aviv, Israel, 6423906
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116
Site 86
Ancona, Italy, 60126
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117
Site 97
Brescia, Italy, 25123
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118
Site 180
Cagliari, Italy, 09121
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119
Site 139
Meldola, Italy, 47014
Actively Recruiting
120
Site 122
Milan, Italy, 20133
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121
Site 81
Milan, Italy, 20141
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122
Site 152
Naples, Italy, 80131
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123
Site 93
Naples, Italy, 80131
Actively Recruiting
124
Site 186
Rome, Italy, 00161
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125
Site 85
Rozzano, Italy, 20089
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126
Site 167
Nagoya, Aichi-ken, Japan, 464-8681
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127
Site 123
Kashiwa, Chiba, Japan, 277-8577
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128
Site 185
Fukuoka, Fukuoka, Japan, 810-8563
Actively Recruiting
129
Site 127
Hiragi, Kagawa-ken, Japan, 761-0793
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130
Site 174
Natori-shi, Miyagi, Japan, 981-1293
Actively Recruiting
131
Site 126
Sendai, Miyagi, Japan, 960-8574
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132
Site 125
Ōsaka-sayama, Osaka, Japan, 589-8511
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133
Site 124
Chuo Ku, Tokyo, Japan, 104-0045
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134
Site 188
Minato-Ku, Tokyo, Japan, 105-8471
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135
Site 183
Kaunas, Lithuania, 50161
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136
Site 179
Vilnius, Lithuania, 08406
Actively Recruiting
137
Site 163
Johor Bahru, Malaysia, 81100
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138
Site 159
Kuching, Malaysia, 93586
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139
Site 161
Putrajaya, Malaysia, 62250
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140
Site 201
Chihuahua City, Mexico, 31000
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141
Site 200
Guadalajara, Mexico, 44680
Actively Recruiting
142
Site 202
Mexico City, Mexico, 06100
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143
Site 84
Amsterdam, Netherlands, 1066 CX
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144
Site 58
Nijmegen, Netherlands, 6525 GA
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145
Site 68
Utrecht, Netherlands, 3584 CX
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146
Site 150
Bydgoszcz, Poland, 85-796
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147
Site 131
Gdansk, Poland, 80-214
Actively Recruiting
148
Site 106
Gliwice, Poland, 44-102
Actively Recruiting
149
Site 116
Krakow, Poland, 31-826
Actively Recruiting
150
Site 190
Lodz, Poland, 93-513
Actively Recruiting
151
Site 158
Warsaw, Poland, 02-781
Actively Recruiting
152
Site 172
Coimbra, Portugal, 3004-561
Actively Recruiting
153
Site 182
Lisbon, Portugal, 1998-018
Actively Recruiting
154
Site 181
Portimão, Portugal, 8500-338
Actively Recruiting
155
Site 175
Porto, Portugal, 4200-072
Actively Recruiting
156
Site 145
Busan, South Korea, 48108
Actively Recruiting
157
Site 13
Goyang-si, South Korea, 10408
Actively Recruiting
158
Site 47
Gyeonggi-do, South Korea, 13496
Withdrawn
159
Site 51
Hwasun, South Korea, 58128
Actively Recruiting
160
Site 28
Seoul, South Korea, 03722
Actively Recruiting
161
Site 35
Seoul, South Korea, 03722
Actively Recruiting
162
Site 45
Seoul, South Korea, 05505
Actively Recruiting
163
Site 42
Suwon, South Korea, 16247
Actively Recruiting
164
Site 157
Suwon, South Korea, 16499
Actively Recruiting
165
Site 120
Badalona, Spain, 08916
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166
Site 80
Barcelona, Spain, 08035
Actively Recruiting
167
Site 128
Madrid, Spain, 28040
Actively Recruiting
168
Site 75
Madrid, Spain, 28040
Actively Recruiting
169
Site 67
Madrid, Spain, 28041
Actively Recruiting
170
Site 160
Madrid, Spain, 28050
Actively Recruiting
171
Site 73
Marbella, Spain, 29660
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172
Site 61
Pamplona, Spain, 31008
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173
Site 62
Pamplona, Spain, 31008
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174
Site 74
Valencia, Spain, 46009
Actively Recruiting
175
Site 41
Changhua, Taiwan, 500
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176
Site 4
Kaohsiung City, Taiwan, 80756
Actively Recruiting
177
Site 103
Kaohsiung City, Taiwan, 833
Actively Recruiting
178
Site 52
Taichung, Taiwan, 40447
Actively Recruiting
179
Site 39
Taipei, Taiwan, 100
Actively Recruiting
180
Site 33
Taipei, Taiwan, 112
Actively Recruiting
181
Site 49
Taoyuan City, Taiwan, 333
Actively Recruiting
182
Site 114
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
183
Site 107
Pathum Wan, Bangkok, Thailand, 10330
Actively Recruiting
184
Site 65
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
185
Site 77
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
186
Site 146
Chiang Rai, Thailand, 57000
Actively Recruiting
187
Site 196
Ankara, Turkey (Türkiye), 06170
Actively Recruiting
188
Site 184
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
189
Site 176
Antalya, Turkey (Türkiye), 07025
Actively Recruiting
190
Site 198
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
191
Site 193
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
192
Site 102
Cambridge, United Kingdom, CB20QQ
Actively Recruiting
193
Site 169
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
194
Site 132
London, United Kingdom, EC1A 7BE
Actively Recruiting
195
Site 90
London, United Kingdom, SE19RT
Actively Recruiting
196
Site 69
London, United Kingdom, SW3 6JJ
Actively Recruiting
197
Site 173
Manchester, United Kingdom, M20 4BX
Actively Recruiting
198
Site 177
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
199
Site 83
Northwood, United Kingdom, HA62RN
Actively Recruiting
200
Site 147
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
201
Site 70
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
202
Site 135
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
Research Team
H
Head of Clinical Operations
CONTACT
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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