A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
NCT ID: NCT06525220
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2024-09-25
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Petosemtamab + Pembrolizumab
Combination Therapy
Petosemtamab
MCLA-158
Pembrolizumab
Humanized Antibody
Pembrolizumab
Monotherapy
Pembrolizumab
Humanized Antibody
Interventions
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Petosemtamab
MCLA-158
Pembrolizumab
Humanized Antibody
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years at signing of ICF
3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.
6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting
7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
9. ECOG Performance Status (PS) of 0-1
10. Life expectancy ≥ 12 weeks, as per investigator assessment.
11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
12. Adequate organ function as defined per protocol.
13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300/µl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy
Exclusion Criteria
2. Known leptomeningeal involvement
3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
4. Requirement for immunosuppressive medication
5. Major surgery or radiotherapy within 3 weeks of randomization
6. Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies
7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.
8. 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 prior to randomization
9. History of prior malignancies within the last 5 years, with the exception of excised local cancer
10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
12. Patients with known infectious diseases as per protocol.
13. Pregnant or breastfeeding patients.
14. The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone \>10 mg/day or equivalent, or any other form of immunosuppressive therapy
15. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment
16. The patient has had an allogeneic tissue/solid organ transplant.
17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)
18 Years
ALL
No
Sponsors
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Merus N.V.
INDUSTRY
Responsible Party
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Locations
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Site 164
Mobile, Alabama, United States
Site 36
La Jolla, California, United States
Site 27
Los Angeles, California, United States
Site 16
Palo Alto, California, United States
Site 19
Newark, Delaware, United States
Site 108
Washington D.C., District of Columbia, United States
Site 14
Fort Myers, Florida, United States
Site 48
Orlando, Florida, United States
Site 8
Orlando, Florida, United States
Site 21
St. Petersburg, Florida, United States
Site 20
West Palm Beach, Florida, United States
Site 171
Atlanta, Georgia, United States
Site 50
Chicago, Illinois, United States
Site 2
Louisville, Kentucky, United States
Site 162
Baton Rouge, Louisiana, United States
Site 155
Minneapolis, Minnesota, United States
Site 168
St Louis, Missouri, United States
Site 94
Hackensack, New Jersey, United States
Site 6
Albuquerque, New Mexico, United States
Site 113
Durham, North Carolina, United States
Site 118
Winston-Salem, North Carolina, United States
Site 43
Philadelphia, Pennsylvania, United States
Site 153
Philadelphia, Pennsylvania, United States
Site 154
Philadelphia, Pennsylvania, United States
Site 89
Chattanooga, Tennessee, United States
Site 115
Memphis, Tennessee, United States
Site 88
Nashville, Tennessee, United States
Site 22
Austin, Texas, United States
Site 1
Houston, Texas, United States
Site 18
Plano, Texas, United States
Site 17
Sugarland, Texas, United States
Site 15
Tyler, Texas, United States
Site 10
Salt Lake City, Utah, United States
Site 12
Blacksburg, Virginia, United States
Site 23
Norfolk, Virginia, United States
Site 170
CABA, , Argentina
Site 96
CABA, , Argentina
Site 37
CABA, , Argentina
Site 31
Córdoba, , Argentina
Site 30
La Rioja, , Argentina
Site 76
Rosario, , Argentina
Site 46
Viedma, , Argentina
Site 11
Blacktown, New South Wales, Australia
Site 24
St Leonards, New South Wales, Australia
Site 166
Greenslopes, Queensland, Australia
Site 151
Melbourne, Victoria, Australia
Site 53
Brussels, , Belgium
Site 98
Edegem, , Belgium
Site 99
Ghent, , Belgium
Site 71
Leuven, , Belgium
Site 109
Liège, , Belgium
Site 63
Namur, , Belgium
Site 149
Rio de Janeiro, Rio de Janeiro, Brazil
Site 141
Belo Horizonte, , Brazil
Site 144
Natal, , Brazil
Site 140
Porto Alegre, , Brazil
Site 142
Porto Alegre, , Brazil
Site 137
Recife, , Brazil
Site 138
Rio de Janeiro, , Brazil
Site 134
São Paulo, , Brazil
Site 136
São Paulo, , Brazil
Site 165
St. John's, , Canada
Site 44
Toronto, , Canada
Site 111
Winnipeg, , Canada
Site 38
Antofagasta, , Chile
Site 26
Providencia, , Chile
Site 29
Recoleta, , Chile
Site 40
Santiago, , Chile
Site 32
Santiago, , Chile
Site 34
Santiago, , Chile
Site 25
Temuco, , Chile
Site 56
Bordeaux, , France
Site 101
Le Mans, , France
Site 79
Lille, , France
Site 72
Lyon, , France
Site 57
Marseille, , France
Site 55
Montpellier, , France
Site 66
Nice, , France
Site 105
Paris, , France
Site 143
Paris, , France
Site 87
Poitiers, , France
Site 54
Rouen, , France
Site 59
Toulouse, , France
Site 64
Vandœuvre-lès-Nancy, , France
Site 112
Villejuif, , France
Site 133
Bonn, , Germany
Site 100
Dresden, , Germany
Site 60
Greifswald, , Germany
Site 82
Hamburg, , Germany
Site 91
Hamburg, , Germany
Site 104
Hanover, , Germany
Site 129
Mannheim, , Germany
Site 148
München, , Germany
Site 121
Münster, , Germany
Site 78
Tübingen, , Germany
Site 130
Ulm, , Germany
Site 110
Würzburg, , Germany
Site 119
Pátrai, Achaia, Greece
Site 156
Athens, Attica, Greece
Site 117
Heraklion, Crete, Greece
Site 95
Chaïdári, , Greece
Site 92
Panórama, , Greece
Site 9
Haifa, , Israel
Site 5
Jerusalem, , Israel
Site 3
Ramat Gan, , Israel
Site 7
Tel Aviv, , Israel
Site 86
Ancona, , Italy
Site 97
Brescia, , Italy
Site 139
Meldola, , Italy
Site 122
Milan, , Italy
Site 81
Milan, , Italy
Site 152
Naples, , Italy
Site 93
Naples, , Italy
Site 85
Rozzano, , Italy
Site 167
Nagoya, Aichi-ken, Japan
Site 123
Kashiwa, Chiba, Japan
Site 127
Hiragi, Kagawa-ken, Japan
Site 174
Natori-shi, Miyagi, Japan
Site 126
Sendai, Miyagi, Japan
Site 125
Ōsaka-sayama, Osaka, Japan
Site 124
Chuo Ku, Tokyo, Japan
Site 163
Johor Bahru, , Malaysia
Site 159
Kuching, , Malaysia
Site 161
Putrajaya, , Malaysia
Site 84
Amsterdam, , Netherlands
Site 58
Nijmegen, , Netherlands
Site 68
Utrecht, , Netherlands
Site 150
Bydgoszcz, , Poland
Site 131
Gdansk, , Poland
Site 106
Gliwice, , Poland
Site 116
Krakow, , Poland
Site 158
Warsaw, , Poland
Site 172
Coimbra, , Portugal
Site 175
Porto, , Portugal
Site 145
Busan, , South Korea
Site 13
Goyang-si, , South Korea
Site 47
Gyeonggi-do, , South Korea
Site 51
Hwasun, , South Korea
Site 28
Seoul, , South Korea
Site 35
Seoul, , South Korea
Site 45
Seoul, , South Korea
Site 42
Suwon, , South Korea
Site 157
Suwon, , South Korea
Site 120
Badalona, , Spain
Site 80
Barcelona, , Spain
Site 128
Madrid, , Spain
Site 75
Madrid, , Spain
Site 67
Madrid, , Spain
Site 160
Madrid, , Spain
Site 73
Marbella, , Spain
Site 61
Pamplona, , Spain
Site 62
Pamplona, , Spain
Site 74
Valencia, , Spain
Site 41
Changhua, , Taiwan
Site 4
Kaohsiung City, , Taiwan
Site 103
Kaohsiung City, , Taiwan
Site 52
Taichung, , Taiwan
Site 39
Taipei, , Taiwan
Site 33
Taipei, , Taiwan
Site 49
Taoyuan, , Taiwan
Site 114
Bangkok Noi, Bangkok, Thailand
Site 107
Pathum Wan, Bangkok, Thailand
Site 65
Ratchathewi, Bangkok, Thailand
Site 146
Chiang Rai, Changwat Chiang Rai, Thailand
Site 77
Hat Yai, Changwat Songkhla, Thailand
Site 102
Cambridge, , United Kingdom
Site 169
Cardiff, , United Kingdom
Site 132
London, , United Kingdom
Site 90
London, , United Kingdom
Site 69
London, , United Kingdom
Site 173
Manchester, , United Kingdom
Site 83
Northwood, , United Kingdom
Site 147
Southampton, , United Kingdom
Site 70
Sutton, , United Kingdom
Site 135
Taunton, , United Kingdom
Countries
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Central Contacts
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References
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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.
Other Identifiers
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MCLA-158-CL03
Identifier Type: -
Identifier Source: org_study_id
2023-510323-30-00
Identifier Type: CTIS
Identifier Source: secondary_id