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)
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
3 other identifiers
interventional
621
24 countries
194
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2024
Longer than P75 for phase_3
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2024
CompletedFirst Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
September 25, 2026
August 1, 2026
3.6 years
July 3, 2024
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Up to approximately 3 years
Secondary Outcomes (15)
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review
Up to approximately 2 years
Duration of Response (DOR) as Assessed by Blinded Independent Central Review
Up to approximately 2 years
Objective Response Rate (ORR) as Assessed by Investigator Review
Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Investigator Review
Up to approximately 2 years
- +10 more secondary outcomes
Study Arms (2)
MCLA-158
EXPERIMENTALInvestigator's Choice
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merus B.V.lead
Study Sites (194)
Site 160
Mobile, Alabama, 36608, United States
Site 102
Prescott, Arizona, 86301, United States
Site 125
Scottsdale, Arizona, 85054, United States
Site 82
Duarte, California, 91010, United States
Site 25
La Jolla, California, 92037, United States
Site 173
Orange, California, 92868, United States
Site 28
Palo Alto, California, 94304, United States
Site 127
Sacramento, California, 95817, United States
Site 46
San Francisco, California, 94158, United States
Site 130
Lone Tree, Colorado, 80124, United States
Site 104
Washington D.C., District of Columbia, 20010, United States
Site 12
Fort Myers, Florida, 33901, United States
Site 123
Jacksonville, Florida, 32224, United States
Site 9
Orlando, Florida, 32827, United States
Site 138
Tampa, Florida, 33612, United States
Site 187
Atlanta, Georgia, 30322, United States
Site 152
Chicago, Illinois, 60607, United States
Site 213
Chicago, Illinois, 60611, United States
Site 68
Chicago, Illinois, 60637, United States
Site 31
Indianapolis, Indiana, 46202, United States
Site 8
Louisville, Kentucky, 40202, United States
Site 40
Baton Rouge, Louisiana, 70809, United States
Site 100
New Orleans, Louisiana, 70121, United States
Site 153
Columbia, Maryland, 21044, United States
Site 77
Boston, Massachusetts, 02215, United States
Site 103
Ann Arbor, Michigan, 48109, United States
Site 5
Detroit, Michigan, 48201, United States
Site 49
Maple Grove, Minnesota, 55369, United States
Site 124
Rochester, Minnesota, 55905, United States
Site 18
St Louis, Missouri, 63110, United States
Site 86
Hackensack, New Jersey, 07601, United States
Site 15
Albuquerque, New Mexico, 87131, United States
Site 24
New York, New York, 10029, United States
Site 214
The Bronx, New York, 10461, United States
Site 98
Chapel Hill, North Carolina, 27514, United States
Site 122
Durham, North Carolina, 27710, United States
Site 23
Cincinnati, Ohio, 45219, United States
Site 218
Cleveland, Ohio, 44106, United States
Site 87
Cleveland, Ohio, 44195, United States
Site 32
Columbus, Ohio, 43210, United States
Site 26
Portland, Oregon, 97213, United States
Site 151
Bensalem, Pennsylvania, 19020, United States
Site 158
Philadelphia, Pennsylvania, 19107, United States
Site 50
Charleston, South Carolina, 29425, United States
Site 60
Chattanooga, Tennessee, 37404, United States
Site 54
Memphis, Tennessee, 38103, United States
Site 59
Nashville, Tennessee, 37203, United States
Site 67
Nashville, Tennessee, 37232, United States
Site 55
Denison, Texas, 75020, United States
Site 34
El Paso, Texas, 79915, United States
Site 51
Houston, Texas, 77030, United States
Site 7
Houston, Texas, 77030, United States
Site 94
Pearland, Texas, 77584, United States
Site 4
Salt Lake City, Utah, 84112, United States
Site 10
Blacksburg, Virginia, 24060, United States
Site 22
Charlottesville, Virginia, 22908, United States
Site 156
Winchester, Virginia, 22601, United States
Site 163
Seattle, Washington, 98109, United States
Site 6
Spokane, Washington, 99202, United States
Site 216
Madison, Wisconsin, 53705, United States
Site 58
Caba, C1280AEB, Argentina
Site 45
Córdoba, X5008HHW, Argentina
Site 110
Rosario, S2000KZE, Argentina
Site 57
Viedma, 8500, Argentina
Site 3
Darlinghurst, 2010, Australia
Site 170
Herston, 4060, Australia
Site 38
Melbourne, 3000, Australia
Site 30
Nedlands, 6009, Australia
Site 11
Saint Leonards, 2065, Australia
Site 73
Sydney, 2050, Australia
Site 56
Brussels, 1200, Belgium
Site 92
Ghent, 9000, Belgium
Site 72
Leuven, 3000, Belgium
Site 108
Liège, 4000, Belgium
Site 69
Namur, 5000, Belgium
Site 154
Brasília, 70390-140, Brazil
Site 145
Porto Alegre, 90110-270, Brazil
Site 150
Porto Alegre, 90610-000, Brazil
Site 146
Recife, 50040-000, Brazil
Site 148
Rio de Janeiro, 22281-100, Brazil
Site 147
São Paulo, 01509-900, Brazil
Site 144
São Paulo, 04538-132, Brazil
Site 172
Montreal, H2X 0A9, Canada
Site 196
Toronto, M4N 3M5, Canada
Site 16
Providencia, 7500859, Chile
Site 20
Recoleta, 8420000, Chile
Site 27
Santiago, 7500921, Chile
Site 21
Santiago, 7560908, Chile
Site 201
Olomouc, 779 00, Czechia
Site 105
Bordeaux, 33075, France
Site 211
Brest, 29200, France
Site 162
Le Mans, 72000, France
Site 149
Lille, 59000, France
Site 118
Lyon, 69373, France
Site 115
Marseille, 13005, France
Site 106
Montpellier, 34298, France
Site 169
Nice, 06189, France
Site 114
Paris, 75005, France
Site 167
Paris, 75013, France
Site 136
Poitiers, 86000, France
Site 141
Rennes, 35042, France
Site 107
Rouen, 76038, France
Site 119
Toulouse, 31059, France
Site 142
Vandœuvre-lès-Nancy, 54519, France
Site 113
Villejuif, 94800, France
Site 121
Berlin, 12203, Germany
Site 210
Dresden, 01307, Germany
Site 165
Essen, 45147, Germany
Site 84
Giessen, 35390, Germany
Site 62
Greifswald, 17475, Germany
Site 112
Hanover, 30625, Germany
Site 116
Leipzig, 04103, Germany
Site 168
München, 81675, Germany
Site 99
Würzburg, 97080, Germany
Site 91
Athens, 124 62, Greece
Site 120
Heraklion, 71500, Greece
Site 126
Rio, 26504, Greece
Site 83
Thessaloniki, 55236, Greece
Site 204
Nyíregyháza, 4400, Hungary
Site 195
Pécs, 7624, Hungary
Site 198
Szeged, 6725, Hungary
Site 19
Haifa, 3109601, Israel
Site 1
Jerusalem, 9112001, Israel
Site 14
Ramat Gan, 5265601, Israel
Site 2
Tel Aviv, 6423906, Israel
Site 93
Brescia, 25123, Italy
Site 111
Cuneo, 12100, Italy
Site 128
Milan, 20133, Italy
Site 81
Milan, 20141, Italy
Site 209
Naples, 80131, Italy
Site 89
Naples, 80131, Italy
Site 203
Roma, 00161, Italy
Site 85
Rozzano, 20089, Italy
Site 132
Chūōku, 104-0045, Japan
Site 192
Fukuoka, 812-8582, Japan
Site 131
Kashiwa, 277-8577, Japan
Site 135
Miki, 761-0793, Japan
Site 139
Nagoya, 464-8681, Japan
Site 186
Natori, 981-1293, Japan
Site 133
Ōsaka-sayama, 589-8511, Japan
Site 134
Sendai, 980-8574, Japan
Site 180
Kaunas, 50161, Lithuania
Site 181
Vilnius, 08406, Lithuania
Site 76
Amsterdam, 1066 CX, Netherlands
Site 61
Nijmegen, 6525 GA, Netherlands
Site 66
Utrecht, 3584 CX, Netherlands
Site 190
Bydgoszcz, 85-796, Poland
Site 143
Gdansk, 80-214, Poland
Site 97
Gliwice, 44-102, Poland
Site 177
Krakow, 31-826, Poland
Site 200
Lodz, 93-513, Poland
Site 117
Poznan, 60-185, Poland
Site 179
Warsaw, 02-781, Poland
Site 182
Coimbra, 3004-561, Portugal
Site 183
Lisbon, 1998-018, Portugal
Site 185
Porto, 4200-072, Portugal
Site 161
Busan, 48108, South Korea
Site 13
Goyang-si, 10408, South Korea
Site 29
Hwasun, 58128, South Korea
Site 137
Seoul, 03080, South Korea
Site 36
Seoul, 05505, South Korea
Site 47
Seoul, 06351, South Korea
Site 33
Soeul, 03722, South Korea
Site 164
Suwon, 16499, South Korea
Site 78
Barcelona, 08035, Spain
Site 109
Madrid, 28040, Spain
Site 75
Madrid, 28040, Spain
Site 71
Madrid, 28041, Spain
Site 166
Madrid, 28050, Spain
Site 63
Pamplona, 31008, Spain
Site 64
Pamplona, 31008, Spain
Site 74
Valencia, 46009, Spain
Site 184
Bellinzona, CH-6500, Switzerland
Site 189
Geneva, 1211, Switzerland
Site 194
Lausanne, 1011, Switzerland
Site 178
Sankt Gallen, 9007, Switzerland
Site 17
Kaohsiung City, 807, Taiwan
Site 95
Kaohsiung City, 833, Taiwan
Site 53
Taichung, 40447, Taiwan
Site 176
Tainan, 70428, Taiwan
Site 35
Taipei, 112, Taiwan
Site 52
Taoyuan City, 333, Taiwan
Site 65
Cambridge, CB2 0QQ, United Kingdom
Site 174
Cardiff, CF14 2TL, United Kingdom
Site 171
Glasgow, G12 0YN, United Kingdom
Site 44
Liverpool, L7 8YA, United Kingdom
Site 157
London, E20 1JQ, United Kingdom
Site 140
London, EC1A 7BE, United Kingdom
Site 90
London, SE1 9RT, United Kingdom
Site 42
London, SW3 6JJ, United Kingdom
Site 48
Manchester, M20 4BX, United Kingdom
Site 70
Middlesex, HA6 2RN, United Kingdom
Site 191
Newcastle upon Tyne, NE7 7DN, United Kingdom
Site 43
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 40511820DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 11, 2024
Study Start
June 25, 2024
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
September 25, 2026
Record last verified: 2026-08