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)

June 2, 2026 updated by: Merus B.V.

A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Study Overview

Status

Recruiting

Conditions

Head and Neck Squamous Cell Carcinoma

Intervention / Treatment

Detailed Description

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

Study Type

Interventional

Enrollment (Estimated)

600

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

Name: Eduardo Pennella, MD
Phone Number: +1 617 401 4499
Email: USenquiries@merus.nl

Study Contact Backup

Name: David Yao, MD
Phone Number: +1 617 401 4499
Email: USenquiries@merus.nl

Study Locations

Argentina
- - Buenos Aires, Argentina, C1125ABD
    - Withdrawn
    - Site 37
  - Buenos Aires, Argentina, C1426ANZ
    - Withdrawn
    - Site 80
  - CABA, Argentina, Clll3AAE
    - Recruiting
    - Site 193
  - Caba, Argentina, C1280AEB
    - Recruiting
    - Site 58
  - Córdoba, Argentina, X5008HHW
    - Recruiting
    - Site 45
  - Rosario, Argentina, S2000KZE
    - Recruiting
    - Site 110
  - Viedma, Argentina, 8500
    - Recruiting
    - Site 57
Australia
- - Darlinghurst, Australia, 2010
    - Recruiting
    - Site 3
  - Herston, Australia, 4060
    - Recruiting
    - Site 170
  - Melbourne, Australia, 3000
    - Recruiting
    - Site 38
  - Nedlands, Australia, 6009
    - Recruiting
    - Site 30
  - Saint Leonards, Australia, 2065
    - Recruiting
    - Site 11
  - Sydney, Australia, 2050
    - Recruiting
    - Site 73
Belgium
- - Brussels, Belgium, 1200
    - Recruiting
    - Site 56
  - Brussels, Belgium, 1070
    - Withdrawn
    - Site 129
  - Ghent, Belgium, 9000
    - Recruiting
    - Site 92
  - Leuven, Belgium, 3000
    - Recruiting
    - Site 72
  - Liège, Belgium, 4000
    - Recruiting
    - Site 108
  - Namur, Belgium, 5000
    - Recruiting
    - Site 69
Brazil
- - Brasília, Brazil, 70390-140
    - Recruiting
    - Site 154
  - Porto Alegre, Brazil, 90110-270
    - Recruiting
    - Site 145
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Site 150
  - Recife, Brazil, 50040-000
    - Recruiting
    - Site 146
  - Rio de Janeiro, Brazil, 22.250-905
    - Recruiting
    - Site 155
  - Rio de Janeiro, Brazil, 22281-100
    - Recruiting
    - Site 148
  - São Paulo, Brazil, 01509-900
    - Recruiting
    - Site 147
  - São Paulo, Brazil, 04538-132
    - Recruiting
    - Site 144
Canada
- - Montreal, Canada, H2X 0A9
    - Recruiting
    - Site 172
  - Toronto, Canada, M4N 3M5
    - Recruiting
    - Site 196
Chile
- - Providencia, Chile, 7500859
    - Recruiting
    - Site 16
  - Recoleta, Chile, 8420000
    - Recruiting
    - Site 20
  - Santiago, Chile, 7560908
    - Recruiting
    - Site 21
  - Santiago, Chile, 7500921
    - Recruiting
    - Site 27
Czechia
- - Nový Jičín, Czechia, 74101
    - Recruiting
    - Site 188
  - Olomouc, Czechia, 779 00
    - Recruiting
    - Site 201
  - Prague, Czechia, 150 06
    - Recruiting
    - Site 202
France
- - Bordeaux, France, 33075
    - Recruiting
    - Site 105
  - Brest, France, 29200
    - Recruiting
    - Site 211
  - Le Mans, France, 72000
    - Recruiting
    - Site 162
  - Lille, France, 59000
    - Recruiting
    - Site 149
  - Lyon, France, 69373
    - Recruiting
    - Site 118
  - Marseille, France, 13005
    - Recruiting
    - Site 115
  - Montpellier, France, 34298
    - Recruiting
    - Site 106
  - Nice, France, 06189
    - Recruiting
    - Site 169
  - Paris, France, 75005
    - Recruiting
    - Site 114
  - Paris, France, 75013
    - Recruiting
    - Site 167
  - Poitiers, France, 86000
    - Recruiting
    - Site 136
  - Rennes, France, 35042
    - Recruiting
    - Site 141
  - Rouen, France, 76038
    - Recruiting
    - Site 107
  - Toulouse, France, 31059
    - Recruiting
    - Site 119
  - Vandœuvre-lès-Nancy, France, 54519
    - Recruiting
    - Site 142
  - Villejuif, France, 94800
    - Recruiting
    - Site 113
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Site 101
  - Berlin, Germany, 12203
    - Recruiting
    - Site 121
  - Dresden, Germany, 01307
    - Recruiting
    - Site 210
  - Essen, Germany, 45147
    - Recruiting
    - Site 165
  - Giessen, Germany, 35390
    - Recruiting
    - Site 84
  - Greifswald, Germany, 17475
    - Recruiting
    - Site 62
  - Hamburg, Germany, 20246
    - Recruiting
    - Site 79
  - Hamburg, Germany, 22763
    - Recruiting
    - Site 88
  - Hanover, Germany, 30625
    - Recruiting
    - Site 112
  - Leipzig, Germany, 04103
    - Recruiting
    - Site 116
  - Mannheim, Germany, 68167
    - Recruiting
    - Site 175
  - München, Germany, 81675
    - Recruiting
    - Site 168
  - Würzburg, Germany, 97080
    - Recruiting
    - Site 99
Greece
- - Athens, Greece, 124 62
    - Recruiting
    - Site 91
  - Athens, Greece, 15123
    - Recruiting
    - Site 96
  - Heraklion, Greece, 71500
    - Recruiting
    - Site 120
  - Rio, Greece, 26504
    - Recruiting
    - Site 126
  - Thessaloniki, Greece, 55236
    - Recruiting
    - Site 83
Hungary
- - Nyíregyháza, Hungary, 4400
    - Recruiting
    - Site 204
  - Pécs, Hungary, 7624
    - Recruiting
    - Site 195
  - Szeged, Hungary, 6725
    - Recruiting
    - Site 198
Israel
- - Haifa, Israel, 3109601
    - Recruiting
    - Site 19
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Site 1
  - Ramat Gan, Israel, 5265601
    - Recruiting
    - Site 14
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Site 2
Italy
- - Brescia, Italy, 25123
    - Recruiting
    - Site 93
  - Cuneo, Italy, 12100
    - Recruiting
    - Site 111
  - Milan, Italy, 20141
    - Recruiting
    - Site 81
  - Milan, Italy, 20133
    - Recruiting
    - Site 128
  - Naples, Italy, 80131
    - Recruiting
    - Site 89
  - Naples, Italy, 80131
    - Recruiting
    - Site 209
  - Roma, Italy, 00161
    - Recruiting
    - Site 203
  - Rozzano, Italy, 20089
    - Recruiting
    - Site 85
Japan
- - Chūōku, Japan, 104-0045
    - Recruiting
    - Site 132
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Site 192
  - Fukuoka, Japan, 810-8563
    - Recruiting
    - Site 199
  - Kashiwa, Japan, 277-8577
    - Recruiting
    - Site 131
  - Miki, Japan, 761-0793
    - Recruiting
    - Site 135
  - Minatoku, Japan, 105-8471
    - Recruiting
    - Site 205
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Site 139
  - Natori, Japan, 981-1293
    - Recruiting
    - Site 186
  - Sendai, Japan, 980-8574
    - Recruiting
    - Site 134
  - Ōsaka-sayama, Japan, 589-8511
    - Recruiting
    - Site 133
Lithuania
- - Kaunas, Lithuania, 50161
    - Recruiting
    - Site 180
  - Vilnius, Lithuania, 08406
    - Recruiting
    - Site 181
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Recruiting
    - Site 76
  - Nijmegen, Netherlands, 6525 GA
    - Recruiting
    - Site 61
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - Site 66
Poland
- - Bydgoszcz, Poland, 85-796
    - Recruiting
    - Site 190
  - Gdansk, Poland, 80-214
    - Recruiting
    - Site 143
  - Gliwice, Poland, 44-102
    - Recruiting
    - Site 97
  - Krakow, Poland, 31-826
    - Recruiting
    - Site 177
  - Lodz, Poland, 93-513
    - Recruiting
    - Site 200
  - Poznan, Poland, 60-185
    - Recruiting
    - Site 117
  - Warsaw, Poland, 02-781
    - Recruiting
    - Site 179
Portugal
- - Coimbra, Portugal, 3004-561
    - Recruiting
    - Site 182
  - Lisbon, Portugal, 1998-018
    - Recruiting
    - Site 183
  - Portimão, Portugal, 8500-338
    - Recruiting
    - Site 197
  - Porto, Portugal, 4200-072
    - Recruiting
    - Site 185
South Korea
- - Busan, South Korea, 48108
    - Recruiting
    - Site 161
  - Busan, South Korea, 49267
    - Recruiting
    - Site 215
  - Daegu, South Korea, 42601
    - Recruiting
    - Site 212
  - Goyang-si, South Korea, 10408
    - Recruiting
    - Site 13
  - Hwasun, South Korea, 58128
    - Recruiting
    - Site 29
  - Seongnam-si, South Korea, 13620
    - Recruiting
    - Site 206
  - Seoul, South Korea, 03080
    - Recruiting
    - Site 137
  - Seoul, South Korea, 05505
    - Recruiting
    - Site 36
  - Seoul, South Korea, 06351
    - Recruiting
    - Site 47
  - Seoul, South Korea, 07061
    - Recruiting
    - Site 208
  - Soeul, South Korea, 03722
    - Recruiting
    - Site 33
  - Suwon, South Korea, 16499
    - Recruiting
    - Site 164
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Site 78
  - Madrid, Spain, 28040
    - Recruiting
    - Site 75
  - Madrid, Spain, 28041
    - Recruiting
    - Site 71
  - Madrid, Spain, 28040
    - Recruiting
    - Site 109
  - Madrid, Spain, 28050
    - Recruiting
    - Site 166
  - Pamplona, Spain, 31008
    - Recruiting
    - Site 63
  - Pamplona, Spain, 31008
    - Recruiting
    - Site 64
  - Valencia, Spain, 46009
    - Recruiting
    - Site 74
Switzerland
- - Bellinzona, Switzerland, CH-6500
    - Recruiting
    - Site 184
  - Geneva, Switzerland, 1211
    - Recruiting
    - Site 189
  - Lausanne, Switzerland, 1011
    - Recruiting
    - Site 194
  - Sankt Gallen, Switzerland, 9007
    - Recruiting
    - Site 178
Taiwan
- - Changhua, Taiwan, 500
    - Withdrawn
    - Site 41
  - Kaohsiung City, Taiwan, 833
    - Recruiting
    - Site 95
  - Kaohsiung City, Taiwan, 807
    - Recruiting
    - Site 17
  - Taichung, Taiwan, 40447
    - Recruiting
    - Site 53
  - Tainan, Taiwan, 70428
    - Recruiting
    - Site 176
  - Taipei, Taiwan, 100
    - Recruiting
    - Site 39
  - Taipei, Taiwan, 112
    - Recruiting
    - Site 35
  - Taoyuan City, Taiwan, 333
    - Recruiting
    - Site 52
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Site 65
  - Cardiff, United Kingdom, CF14 2TL
    - Recruiting
    - Site 174
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - Site 171
  - Liverpool, United Kingdom, L7 8YA
    - Recruiting
    - Site 44
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - Site 42
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Site 90
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Site 140
  - London, United Kingdom, E20 1JQ
    - Recruiting
    - Site 157
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Site 48
  - Middlesex, United Kingdom, HA6 2RN
    - Recruiting
    - Site 70
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - Site 191
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Site 43
United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Recruiting
    - Site 160
- Arizona
  - Prescott, Arizona, United States, 86301
    - Completed
    - Site 102
  - Scottsdale, Arizona, United States, 85054
    - Recruiting
    - Site 125
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - Site 82
  - La Jolla, California, United States, 92037
    - Recruiting
    - Site 25
  - Orange, California, United States, 92868
    - Recruiting
    - Site 173
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Site 28
  - Sacramento, California, United States, 95817
    - Recruiting
    - Site 127
  - San Francisco, California, United States, 94158
    - Recruiting
    - Site 46
- Colorado
  - Lone Tree, Colorado, United States, 80124
    - Recruiting
    - Site 130
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Recruiting
    - Site 104
- Florida
  - Fort Myers, Florida, United States, 33901
    - Recruiting
    - Site 12
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Site 123
  - Orlando, Florida, United States, 32827
    - Recruiting
    - Site 9
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Site 138
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Site 187
  - Atlanta, Georgia, United States, 30341
    - Recruiting
    - Site 207
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - Site 68
  - Chicago, Illinois, United States, 60607
    - Recruiting
    - Site 152
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Site 213
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Site 31
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Site 8
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Recruiting
    - Site 40
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Site 100
- Maryland
  - Columbia, Maryland, United States, 21044
    - Recruiting
    - Site 153
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Site 77
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - Site 103
  - Detroit, Michigan, United States, 48201
    - Recruiting
    - Site 5
- Minnesota
  - Maple Grove, Minnesota, United States, 55369
    - Recruiting
    - Site 49
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Site 124
- Missouri
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Site 18
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Site 86
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - Recruiting
    - Site 15
- New York
  - New York, New York, United States, 10029
    - Recruiting
    - Site 24
  - The Bronx, New York, United States, 10461
    - Recruiting
    - Site 214
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Recruiting
    - Site 98
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Site 122
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - Site 23
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Site 87
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Site 32
- Oregon
  - Portland, Oregon, United States, 97213
    - Recruiting
    - Site 26
- Pennsylvania
  - Bensalem, Pennsylvania, United States, 19020
    - Recruiting
    - Site 151
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Site 158
  - Philadelphia, Pennsylvania, United States, 19114
    - Recruiting
    - Site 159
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Site 50
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Site 60
  - Memphis, Tennessee, United States, 38103
    - Recruiting
    - Site 54
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Site 59
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Site 67
- Texas
  - Denison, Texas, United States, 75020
    - Recruiting
    - Site 55
  - El Paso, Texas, United States, 79915
    - Recruiting
    - Site 34
  - Houston, Texas, United States, 77030
    - Recruiting
    - Site 7
  - Houston, Texas, United States, 77030
    - Recruiting
    - Site 51
  - Pearland, Texas, United States, 77584
    - Recruiting
    - Site 94
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - Site 4
- Virginia
  - Blacksburg, Virginia, United States, 24060
    - Recruiting
    - Site 10
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - Site 22
  - Winchester, Virginia, United States, 22601
    - Recruiting
    - Site 156
- Washington
  - Seattle, Washington, United States, 98109
    - Recruiting
    - Site 163
  - Spokane, Washington, United States, 99202
    - Recruiting
    - Site 6
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - Recruiting
    - Site 216

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

Description

Inclusion Criteria:

Signed ICF before initiation of any study procedures.
Age ≥ 18 years at signing of ICF.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Documentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer.
A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
ECOG PS of 0 or 1
Life expectancy ≥ 12 weeks, as per investigator
Adequate organ function (as per protocol)

Exclusion Criteria:

Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
Known leptomeningeal involvement
Any systemic anticancer therapy within 4 weeks prior to randomization.
Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Participants with known infectious diseases (as per protocol)
Pregnant or breastfeeding participants
Participant has a primary tumor site of nasopharynx (any histology).

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: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Investigator's Choice	Drug: Investigator's Choice Cetuximab Drug: Investigator's Choice Methotrexate Drug: Investigator's Choice Docetaxel
Experimental: MCLA-158	Drug: Petosemtamab MCLA-158

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to approximately 3 years	OS was defined as the time from randomization to death due to any cause.	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review Time Frame: Up to approximately 2 years	ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.	Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review Time Frame: Up to approximately 2 years	PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.	Up to approximately 2 years
Duration of Response (DOR) as Assessed by Blinded Independent Central Review Time Frame: Up to approximately 2 years	For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.	Up to approximately 2 years
Objective Response Rate (ORR) as Assessed by Investigator Review Time Frame: Up to approximately 2 years	ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.	Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Investigator Review Time Frame: Up to approximately 2 years	PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.	Up to approximately 2 years
Duration of Response (DOR) as Assessed by Investigator Review Time Frame: Up to approximately 2 years	For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of the first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.	Up to approximately 2 years
Time to Response (TTR) as Assessed by Blinded Independent Central Review Time Frame: Up to approximately 2 years	For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.	Up to approximately 2 years
Time to Response (TTR) as Assessed by Investigator Review Time Frame: Up to approximately 2 years	For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.	Up to approximately 2 years
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review Time Frame: Up to approximately 2 years	CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1	Up to approximately 2 years
Clinical Benefit Rate (CBR) as Assessed by Investigator Review Time Frame: Up to approximately 2 years	CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1	Up to approximately 2 years
Mean Change From Baseline in EORTC QLQ-C30 Time Frame: Up to approximately 2 years	For the EORTC QLQ-C30, the functional scales, the symptom scales, the specific single items, and the global health and quality of life scale, will be computed according to EORTC QLQ-C30 Scoring Manual. Mean change from baseline is presented.	Up to approximately 2 years
Pharmacokinetic parameters Time Frame: Up to first 6 cycles	Clearance of plasma and central volume of distribution based on population PK model	Up to first 6 cycles
Incidence of anti-drug antibody (ADA) Time Frame: Up to 30 days post-last dose	The frequency and proportion of participants developing anti-drug antibodies.	Up to 30 days post-last dose
Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE) Time Frame: Up to 30 days post-last dose	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one TEAE is presented.	Up to 30 days post-last dose
Number of Participants who Experienced At Least One Serious TEAE Time Frame: Up to 30 days post-last dose	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one serious TEAE is presented.	Up to 30 days post-last dose
Number of Participants who Discontinued Study Treatment Due to TEAEs Time Frame: Up to 30 days post-last dose	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who discontinued study treatment due to TEAEs is presented.	Up to 30 days post-last dose
Number of Participants who had Dose Modification Due to TEAEs Time Frame: Up to 30 days post-last dose	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who had dose modification due to TEAEs is presented.	Up to 30 days post-last dose
Mean Change From Baseline in EORTC QLQ-H&N43 Time Frame: Up to approximately 2 years	For the EORTC QLQ-H&N43, the multi-item scales and the single-items will be computed according to EORTC QLW-HN43 Scoring Manual. Mean change from baseline is presented.	Up to approximately 2 years
Mean Change From Baseline in EuroQol EQ-5D-5L Time Frame: Up to approximately 2 years	For the EuroQol EQ-5D-5L, the 5 domains and the visual analog scale will be summarized. Mean change from baseline will be presented.	Up to approximately 2 years
Scores in the Patient Global Impression of Change (PGIC) scale Time Frame: Up to approximately 2 years	For the PGIC scale, overall improvement since beginning treatment will be summarized.	Up to approximately 2 years
Concentrations Predose and at End of Infusion Time Frame: Up to first 6 cycles	Predose and end of infusion plasma concentrations as measured from all individual plasma concentrations.	Up to first 6 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merus B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Machiels JP, Fayette J, Haddad R, Adkins D, Gillison M, Harrington KJ, Kim SB, Le Tourneau C, Psyrri A, Rosenberg A, Siu LL, Tahara M, William WN Jr, Ford J, Jauhari S, Pyle R, Shen YM, Yao D, Zohren F, Vokes E. LiGeR-HN phase III trials of petosemtamab + pembrolizumab and petosemtamab monotherapy in recurrent or metastatic HNSCC. Future Oncol. 2025 Jul;21(16):2007-2016. doi: 10.1080/14796694.2025.2511470. Epub 2025 Jun 13.

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 (Actual)

June 25, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

HNSCC

Additional Relevant MeSH Terms

Other Study ID Numbers

MCLA-158-CL02
2023-510322-32-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Head and Neck Squamous Cell Carcinoma

Clinical Trials on Petosemtamab

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