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
ID06496178
A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma
Led by Merus B.V. · Updated on 2026-06-03
600
Participants Needed
216
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating petosemtamab compared with investigator's choice monotherapy in patients with incurable, metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) who have previously received treatment. This phase 3 open-label, randomized, controlled, multicenter study focuses on patients whose disease progressed after anti-PD-1 and platinum-containing therapies. The study aims to assess treatment options for second- and third-line therapy in this challenging condition. Participants will be randomly assigned to receive either petosemtamab or one of several investigator-chosen monotherapies, including cetuximab, methotrexate, or docetaxel. The study compares these treatment approaches without masking, allowing patients and researchers to know the assigned therapies. Treatments will be provided according to the study protocol, with follow-up to monitor effects and safety. During the study, participants will undergo assessments including radiologic evaluations to measure tumor response, laboratory tests to monitor organ function, and quality of life questionnaires. The main outcome is overall survival tracked for up to about three years, with additional measures such as response rate, progression-free survival, and treatment-related side effects observed for up to two years. Safety will be closely monitored, including adverse events and antibody responses, ensuring comprehensive evaluation throughout the study period.
CONDITIONS
Brief Title
A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before starting any study procedures
- Age 18 years or older at time of consent
- Histologically confirmed head and neck squamous cell carcinoma with metastatic or locally advanced disease not curable by standard treatments
- Disease progressed on or after anti-PD-1 therapy and platinum-containing chemotherapy
- Primary tumor located in oropharynx, oral cavity, hypopharynx, or larynx
- Documented p16 status for oropharyngeal cancer patients
- Availability of a new tumor sample or existing suitable tumor tissue sample
- Measurable disease by radiologic methods according to RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks as assessed by investigator
- Adequate organ function as defined in the study protocol
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases or leptomeningeal involvement
- Use of any systemic anticancer therapy within 4 weeks before randomization
- Major surgery within 3 weeks or palliative radiotherapy within 2 weeks before randomization
- Persistent clinically significant toxicities greater than Grade 1 from prior cancer treatments
- History of allergic reactions to any study treatment components
- Unstable angina, serious heart failure, or recent myocardial infarction within 6 months
- History of prior cancers except for certain localized cancers treated curatively
- Current resting dyspnea or diseases requiring continuous oxygen therapy
- Serious uncontrolled illnesses including infections, pulmonary, metabolic, or psychiatric disorders
- Known infectious diseases as outlined in the protocol
- Pregnancy or breastfeeding
- Primary tumor site in the nasopharynx (any histology)
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 petosemtamab or investigator's choice monotherapy as second- or third-line treatment for incurable metastatic or recurrent head and neck squamous cell carcinoma.
Visits scheduled according to treatment cycles and assessments
Follow-up
Duration - Up to approximately 3 years
Participants are monitored for overall survival and safety outcomes after treatment ends.
Periodic visits for follow-up assessments
Trial Site Locations
Total: 216 locations
1
Site 160
Mobile, Alabama, United States, 36608
Actively Recruiting
2
Site 102
Prescott, Arizona, United States, 86301
Completed
3
Site 125
Scottsdale, Arizona, United States, 85054
Actively Recruiting
4
Site 82
Duarte, California, United States, 91010
Actively Recruiting
5
Site 25
La Jolla, California, United States, 92037
Actively Recruiting
6
Site 173
Orange, California, United States, 92868
Actively Recruiting
7
Site 28
Palo Alto, California, United States, 94304
Actively Recruiting
8
Site 127
Sacramento, California, United States, 95817
Actively Recruiting
9
Site 46
San Francisco, California, United States, 94158
Actively Recruiting
10
Site 130
Lone Tree, Colorado, United States, 80124
Actively Recruiting
11
Site 104
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
12
Site 12
Fort Myers, Florida, United States, 33901
Actively Recruiting
13
Site 123
Jacksonville, Florida, United States, 32224
Actively Recruiting
14
Site 9
Orlando, Florida, United States, 32827
Actively Recruiting
15
Site 138
Tampa, Florida, United States, 33612
Actively Recruiting
16
Site 187
Atlanta, Georgia, United States, 30322
Actively Recruiting
17
Site 207
Atlanta, Georgia, United States, 30341
Actively Recruiting
18
Site 152
Chicago, Illinois, United States, 60607
Actively Recruiting
19
Site 213
Chicago, Illinois, United States, 60611
Actively Recruiting
20
Site 68
Chicago, Illinois, United States, 60637
Actively Recruiting
21
Site 31
Indianapolis, Indiana, United States, 46202
Actively Recruiting
22
Site 8
Louisville, Kentucky, United States, 40202
Actively Recruiting
23
Site 40
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
24
Site 100
New Orleans, Louisiana, United States, 70121
Actively Recruiting
25
Site 153
Columbia, Maryland, United States, 21044
Actively Recruiting
26
Site 77
Boston, Massachusetts, United States, 02215
Actively Recruiting
27
Site 103
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
28
Site 5
Detroit, Michigan, United States, 48201
Actively Recruiting
29
Site 49
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
30
Site 124
Rochester, Minnesota, United States, 55905
Actively Recruiting
31
Site 18
St Louis, Missouri, United States, 63110
Actively Recruiting
32
Site 86
Hackensack, New Jersey, United States, 07601
Actively Recruiting
33
Site 15
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
34
Site 24
New York, New York, United States, 10029
Actively Recruiting
35
Site 214
The Bronx, New York, United States, 10461
Actively Recruiting
36
Site 98
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
37
Site 122
Durham, North Carolina, United States, 27710
Actively Recruiting
38
Site 23
Cincinnati, Ohio, United States, 45219
Actively Recruiting
39
Site 87
Cleveland, Ohio, United States, 44195
Actively Recruiting
40
Site 32
Columbus, Ohio, United States, 43210
Actively Recruiting
41
Site 26
Portland, Oregon, United States, 97213
Actively Recruiting
42
Site 151
Bensalem, Pennsylvania, United States, 19020
Actively Recruiting
43
Site 158
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
44
Site 159
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
45
Site 50
Charleston, South Carolina, United States, 29425
Actively Recruiting
46
Site 60
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
47
Site 54
Memphis, Tennessee, United States, 38103
Actively Recruiting
48
Site 59
Nashville, Tennessee, United States, 37203
Actively Recruiting
49
Site 67
Nashville, Tennessee, United States, 37232
Actively Recruiting
50
Site 55
Denison, Texas, United States, 75020
Actively Recruiting
51
Site 34
El Paso, Texas, United States, 79915
Actively Recruiting
52
Site 51
Houston, Texas, United States, 77030
Actively Recruiting
53
Site 7
Houston, Texas, United States, 77030
Actively Recruiting
54
Site 94
Pearland, Texas, United States, 77584
Actively Recruiting
55
Site 4
Salt Lake City, Utah, United States, 84112
Actively Recruiting
56
Site 10
Blacksburg, Virginia, United States, 24060
Actively Recruiting
57
Site 22
Charlottesville, Virginia, United States, 22908
Actively Recruiting
58
Site 156
Winchester, Virginia, United States, 22601
Actively Recruiting
59
Site 163
Seattle, Washington, United States, 98109
Actively Recruiting
60
Site 6
Spokane, Washington, United States, 99202
Actively Recruiting
61
Site 216
Madison, Wisconsin, United States, 53705
Actively Recruiting
62
Site 37
Buenos Aires, Argentina, C1125ABD
Withdrawn
63
Site 80
Buenos Aires, Argentina, C1426ANZ
Withdrawn
64
Site 58
Caba, Argentina, C1280AEB
Actively Recruiting
65
Site 193
CABA, Argentina, Clll3AAE
Actively Recruiting
66
Site 45
Córdoba, Argentina, X5008HHW
Actively Recruiting
67
Site 110
Rosario, Argentina, S2000KZE
Actively Recruiting
68
Site 57
Viedma, Argentina, 8500
Actively Recruiting
69
Site 3
Darlinghurst, Australia, 2010
Actively Recruiting
70
Site 170
Herston, Australia, 4060
Actively Recruiting
71
Site 38
Melbourne, Australia, 3000
Actively Recruiting
72
Site 30
Nedlands, Australia, 6009
Actively Recruiting
73
Site 11
Saint Leonards, Australia, 2065
Actively Recruiting
74
Site 73
Sydney, Australia, 2050
Actively Recruiting
75
Site 129
Brussels, Belgium, 1070
Withdrawn
76
Site 56
Brussels, Belgium, 1200
Actively Recruiting
77
Site 92
Ghent, Belgium, 9000
Actively Recruiting
78
Site 72
Leuven, Belgium, 3000
Actively Recruiting
79
Site 108
Liège, Belgium, 4000
Actively Recruiting
80
Site 69
Namur, Belgium, 5000
Actively Recruiting
81
Site 154
Brasília, Brazil, 70390-140
Actively Recruiting
82
Site 145
Porto Alegre, Brazil, 90110-270
Actively Recruiting
83
Site 150
Porto Alegre, Brazil, 90610-000
Actively Recruiting
84
Site 146
Recife, Brazil, 50040-000
Actively Recruiting
85
Site 155
Rio de Janeiro, Brazil, 22.250-905
Actively Recruiting
86
Site 148
Rio de Janeiro, Brazil, 22281-100
Actively Recruiting
87
Site 147
São Paulo, Brazil, 01509-900
Actively Recruiting
88
Site 144
São Paulo, Brazil, 04538-132
Actively Recruiting
89
Site 172
Montreal, Canada, H2X 0A9
Actively Recruiting
90
Site 196
Toronto, Canada, M4N 3M5
Actively Recruiting
91
Site 16
Providencia, Chile, 7500859
Actively Recruiting
92
Site 20
Recoleta, Chile, 8420000
Actively Recruiting
93
Site 27
Santiago, Chile, 7500921
Actively Recruiting
94
Site 21
Santiago, Chile, 7560908
Actively Recruiting
95
Site 188
Nový Jičín, Czechia, 74101
Actively Recruiting
96
Site 201
Olomouc, Czechia, 779 00
Actively Recruiting
97
Site 202
Prague, Czechia, 150 06
Actively Recruiting
98
Site 105
Bordeaux, France, 33075
Actively Recruiting
99
Site 211
Brest, France, 29200
Actively Recruiting
100
Site 162
Le Mans, France, 72000
Actively Recruiting
101
Site 149
Lille, France, 59000
Actively Recruiting
102
Site 118
Lyon, France, 69373
Actively Recruiting
103
Site 115
Marseille, France, 13005
Actively Recruiting
104
Site 106
Montpellier, France, 34298
Actively Recruiting
105
Site 169
Nice, France, 06189
Actively Recruiting
106
Site 114
Paris, France, 75005
Actively Recruiting
107
Site 167
Paris, France, 75013
Actively Recruiting
108
Site 136
Poitiers, France, 86000
Actively Recruiting
109
Site 141
Rennes, France, 35042
Actively Recruiting
110
Site 107
Rouen, France, 76038
Actively Recruiting
111
Site 119
Toulouse, France, 31059
Actively Recruiting
112
Site 142
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
113
Site 113
Villejuif, France, 94800
Actively Recruiting
114
Site 101
Aachen, Germany, 52074
Actively Recruiting
115
Site 121
Berlin, Germany, 12203
Actively Recruiting
116
Site 210
Dresden, Germany, 01307
Actively Recruiting
117
Site 165
Essen, Germany, 45147
Actively Recruiting
118
Site 84
Giessen, Germany, 35390
Actively Recruiting
119
Site 62
Greifswald, Germany, 17475
Actively Recruiting
120
Site 79
Hamburg, Germany, 20246
Actively Recruiting
121
Site 88
Hamburg, Germany, 22763
Actively Recruiting
122
Site 112
Hanover, Germany, 30625
Actively Recruiting
123
Site 116
Leipzig, Germany, 04103
Actively Recruiting
124
Site 175
Mannheim, Germany, 68167
Actively Recruiting
125
Site 168
München, Germany, 81675
Actively Recruiting
126
Site 99
Würzburg, Germany, 97080
Actively Recruiting
127
Site 91
Athens, Greece, 124 62
Actively Recruiting
128
Site 96
Athens, Greece, 15123
Actively Recruiting
129
Site 120
Heraklion, Greece, 71500
Actively Recruiting
130
Site 126
Rio, Greece, 26504
Actively Recruiting
131
Site 83
Thessaloniki, Greece, 55236
Actively Recruiting
132
Site 204
Nyíregyháza, Hungary, 4400
Actively Recruiting
133
Site 195
Pécs, Hungary, 7624
Actively Recruiting
134
Site 198
Szeged, Hungary, 6725
Actively Recruiting
135
Site 19
Haifa, Israel, 3109601
Actively Recruiting
136
Site 1
Jerusalem, Israel, 9112001
Actively Recruiting
137
Site 14
Ramat Gan, Israel, 5265601
Actively Recruiting
138
Site 2
Tel Aviv, Israel, 6423906
Actively Recruiting
139
Site 93
Brescia, Italy, 25123
Actively Recruiting
140
Site 111
Cuneo, Italy, 12100
Actively Recruiting
141
Site 128
Milan, Italy, 20133
Actively Recruiting
142
Site 81
Milan, Italy, 20141
Actively Recruiting
143
Site 209
Naples, Italy, 80131
Actively Recruiting
144
Site 89
Naples, Italy, 80131
Actively Recruiting
145
Site 203
Roma, Italy, 00161
Actively Recruiting
146
Site 85
Rozzano, Italy, 20089
Actively Recruiting
147
Site 132
Chūōku, Japan, 104-0045
Actively Recruiting
148
Site 199
Fukuoka, Japan, 810-8563
Actively Recruiting
149
Site 192
Fukuoka, Japan, 812-8582
Actively Recruiting
150
Site 131
Kashiwa, Japan, 277-8577
Actively Recruiting
151
Site 135
Miki, Japan, 761-0793
Actively Recruiting
152
Site 205
Minatoku, Japan, 105-8471
Actively Recruiting
153
Site 139
Nagoya, Japan, 464-8681
Actively Recruiting
154
Site 186
Natori, Japan, 981-1293
Actively Recruiting
155
Site 133
Ōsaka-sayama, Japan, 589-8511
Actively Recruiting
156
Site 134
Sendai, Japan, 980-8574
Actively Recruiting
157
Site 180
Kaunas, Lithuania, 50161
Actively Recruiting
158
Site 181
Vilnius, Lithuania, 08406
Actively Recruiting
159
Site 76
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
160
Site 61
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
161
Site 66
Utrecht, Netherlands, 3584 CX
Actively Recruiting
162
Site 190
Bydgoszcz, Poland, 85-796
Actively Recruiting
163
Site 143
Gdansk, Poland, 80-214
Actively Recruiting
164
Site 97
Gliwice, Poland, 44-102
Actively Recruiting
165
Site 177
Krakow, Poland, 31-826
Actively Recruiting
166
Site 200
Lodz, Poland, 93-513
Actively Recruiting
167
Site 117
Poznan, Poland, 60-185
Actively Recruiting
168
Site 179
Warsaw, Poland, 02-781
Actively Recruiting
169
Site 182
Coimbra, Portugal, 3004-561
Actively Recruiting
170
Site 183
Lisbon, Portugal, 1998-018
Actively Recruiting
171
Site 197
Portimão, Portugal, 8500-338
Actively Recruiting
172
Site 185
Porto, Portugal, 4200-072
Actively Recruiting
173
Site 161
Busan, South Korea, 48108
Actively Recruiting
174
Site 215
Busan, South Korea, 49267
Actively Recruiting
175
Site 212
Daegu, South Korea, 42601
Actively Recruiting
176
Site 13
Goyang-si, South Korea, 10408
Actively Recruiting
177
Site 29
Hwasun, South Korea, 58128
Actively Recruiting
178
Site 206
Seongnam-si, South Korea, 13620
Actively Recruiting
179
Site 137
Seoul, South Korea, 03080
Actively Recruiting
180
Site 36
Seoul, South Korea, 05505
Actively Recruiting
181
Site 47
Seoul, South Korea, 06351
Actively Recruiting
182
Site 208
Seoul, South Korea, 07061
Actively Recruiting
183
Site 33
Soeul, South Korea, 03722
Actively Recruiting
184
Site 164
Suwon, South Korea, 16499
Actively Recruiting
185
Site 78
Barcelona, Spain, 08035
Actively Recruiting
186
Site 109
Madrid, Spain, 28040
Actively Recruiting
187
Site 75
Madrid, Spain, 28040
Actively Recruiting
188
Site 71
Madrid, Spain, 28041
Actively Recruiting
189
Site 166
Madrid, Spain, 28050
Actively Recruiting
190
Site 63
Pamplona, Spain, 31008
Actively Recruiting
191
Site 64
Pamplona, Spain, 31008
Actively Recruiting
192
Site 74
Valencia, Spain, 46009
Actively Recruiting
193
Site 184
Bellinzona, Switzerland, CH-6500
Actively Recruiting
194
Site 189
Geneva, Switzerland, 1211
Actively Recruiting
195
Site 194
Lausanne, Switzerland, 1011
Actively Recruiting
196
Site 178
Sankt Gallen, Switzerland, 9007
Actively Recruiting
197
Site 41
Changhua, Taiwan, 500
Withdrawn
198
Site 17
Kaohsiung City, Taiwan, 807
Actively Recruiting
199
Site 95
Kaohsiung City, Taiwan, 833
Actively Recruiting
200
Site 53
Taichung, Taiwan, 40447
Actively Recruiting
201
Site 176
Tainan, Taiwan, 70428
Actively Recruiting
202
Site 39
Taipei, Taiwan, 100
Actively Recruiting
203
Site 35
Taipei, Taiwan, 112
Actively Recruiting
204
Site 52
Taoyuan City, Taiwan, 333
Actively Recruiting
205
Site 65
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
206
Site 174
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
207
Site 171
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
208
Site 44
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
209
Site 157
London, United Kingdom, E20 1JQ
Actively Recruiting
210
Site 140
London, United Kingdom, EC1A 7BE
Actively Recruiting
211
Site 90
London, United Kingdom, SE1 9RT
Actively Recruiting
212
Site 42
London, United Kingdom, SW3 6JJ
Actively Recruiting
213
Site 48
Manchester, United Kingdom, M20 4BX
Actively Recruiting
214
Site 70
Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
215
Site 191
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
216
Site 43
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Loading map...
Research Team
D
David Yao, MD
E
Eduardo Pennella, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here