A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Petosemtamab; Drug: Pembrolizumab

Detailed Description

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+ HNSCC. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was >1 year after the last dose of cetuximab are eligible.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Head of Clinical Operations; Phone Number: +1 617 401 4499; Email: USenquiries@merus.nl

Study Locations

• Argentina
  • CABA, Argentina, C1118AAT
    • Recruiting
    • Site 96
  • CABA, Argentina, C1113AAE
    • Recruiting
    • Site 170
  • CABA, Argentina, C1125ABD
    • Withdrawn
    • Site 37
  • Córdoba, Argentina, X5008HHW
    • Recruiting
    • Site 31
  • La Rioja, Argentina, 5300
    • Recruiting
    • Site 30
  • Rosario, Argentina, S2000KZE
    • Recruiting
    • Site 76
  • Viedma, Argentina, R8500ACE
    • Recruiting
    • Site 46
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Site 11
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • Site 24
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Recruiting
      • Site 166
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Site 151
• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Site 53
  • Edegem, Belgium, 2650
    • Recruiting
    • Site 98
  • Ghent, Belgium, 9000
    • Recruiting
    • Site 99
  • Leuven, Belgium, 3000
    • Recruiting
    • Site 71
  • Liège, Belgium, 4000
    • Recruiting
    • Site 109
  • Namur, Belgium, 5000
    • Recruiting
    • Site 63
• Brazil
  • Belo Horizonte, Brazil, 30.360-680
    • Recruiting
    • Site 141
  • Natal, Brazil, 59020-340
    • Recruiting
    • Site 144
  • Porto Alegre, Brazil, 90610-000
    • Recruiting
    • Site 140
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Site 142
  • Recife, Brazil, 50040-000
    • Recruiting
    • Site 137
  • Rio de Janeiro, Brazil, 22281-100
    • Recruiting
    • Site 138
  • Rio de Janeiro, Brazil, 22.250-905
    • Recruiting
    • Site 149
  • São Paulo, Brazil, 01509-900
    • Recruiting
    • Site 134
  • São Paulo, Brazil, 04538-132
    • Recruiting
    • Site 136
• Canada
  • St. John's, Canada, A1B3V6
    • Recruiting
    • Site 165
  • Toronto, Canada, M5G 2M9
    • Recruiting
    • Site 44
  • Winnipeg, Canada, R3E0V9
    • Recruiting
    • Site 111
• Chile
  • Antofagasta, Chile, 1263521
    • Recruiting
    • Site 38
  • Providencia, Chile, 7500859
    • Recruiting
    • Site 26
  • Recoleta, Chile, 8420000
    • Recruiting
    • Site 29
  • Santiago, Chile, 7500921
    • Recruiting
    • Site 40
  • Santiago, Chile, 7560908
    • Recruiting
    • Site 32
  • Santiago, Chile, 8330336
    • Recruiting
    • Site 34
  • Temuco, Chile, 76281055-7
    • Recruiting
    • Site 25
• Croatia
  • Osijek, Croatia, 31000
    • Recruiting
    • Site 205
  • Split, Croatia, 21000
    • Recruiting
    • Site 199
  • Zagreb, Croatia, 10000
    • Recruiting
    • Site 204
• Czechia
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Site 195
  • Prague, Czechia, 150 06
    • Recruiting
    • Site 192
• France
  • Bordeaux, France, 33075
    • Recruiting
    • Site 56
  • Le Mans, France, 72000
    • Recruiting
    • Site 101
  • Lille, France, 59000
    • Recruiting
    • Site 79
  • Lyon, France, 69378
    • Recruiting
    • Site 72
  • Marseille, France, 13005
    • Recruiting
    • Site 57
  • Montpellier, France, 34298
    • Recruiting
    • Site 55
  • Nice, France, 06189
    • Recruiting
    • Site 66
  • Paris, France, 75005
    • Recruiting
    • Site 105
  • Paris, France, 75013
    • Recruiting
    • Site 143
  • Poitiers, France, 86021
    • Recruiting
    • Site 87
  • Rouen, France, 76038
    • Recruiting
    • Site 54
  • Toulouse, France, 31100
    • Recruiting
    • Site 59
  • Vandœuvre-lès-Nancy, France, 54519
    • Recruiting
    • Site 64
  • Villejuif, France, 94800
    • Recruiting
    • Site 112
• Germany
  • Bonn, Germany, 53175
    • Recruiting
    • Site 133
  • Dortmund, Germany, 44137
    • Recruiting
    • Site 178
  • Dresden, Germany, 01307
    • Recruiting
    • Site 100
  • Greifswald, Germany, 17475
    • Recruiting
    • Site 60
  • Hamburg, Germany, 20251
    • Recruiting
    • Site 82
  • Hamburg, Germany, 22763
    • Recruiting
    • Site 91
  • Hanover, Germany, 30625
    • Recruiting
    • Site 104
  • Mannheim, Germany, 68167
    • Recruiting
    • Site 129
  • München, Germany, 81675
    • Recruiting
    • Site 148
  • Münster, Germany, 48149
    • Recruiting
    • Site 121
  • Tübingen, Germany, 72076
    • Recruiting
    • Site 78
  • Ulm, Germany, 89075
    • Recruiting
    • Site 130
  • Würzburg, Germany, 97080
    • Recruiting
    • Site 110
• Greece
  • Chaïdári, Greece, 12462
    • Recruiting
    • Site 95
  • Panórama, Greece, 55236
    • Recruiting
    • Site 92
  • Achaia
    • Pátrai, Achaia, Greece, 265 04
      • Recruiting
      • Site 119
  • Attica
    • Athens, Attica, Greece, 151 23
      • Recruiting
      • Site 156
  • Crete
    • Heraklion, Crete, Greece, 715 00
      • Recruiting
      • Site 117
• Hungary
  • Nyíregyháza, Hungary, 4400
    • Recruiting
    • Site 194
  • Pécs, Hungary, 7624
    • Recruiting
    • Site 189
  • Szeged, Hungary, 6720
    • Recruiting
    • Site 187
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Site 9
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Site 5
  • Ramat Gan, Israel, 5266202
    • Recruiting
    • Site 3
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Site 7
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Site 86
  • Brescia, Italy, 25123
    • Recruiting
    • Site 97
  • Cagliari, Italy, 09121
    • Recruiting
    • Site 180
  • Meldola, Italy, 47014
    • Recruiting
    • Site 139
  • Milan, Italy, 20141
    • Recruiting
    • Site 81
  • Milan, Italy, 20133
    • Recruiting
    • Site 122
  • Naples, Italy, 80131
    • Recruiting
    • Site 93
  • Naples, Italy, 80131
    • Recruiting
    • Site 152
  • Rome, Italy, 00161
    • Recruiting
    • Site 186
  • Rozzano, Italy, 20089
    • Recruiting
    • Site 85
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Site 167
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • Site 123
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 810-8563
      • Recruiting
      • Site 185
  • Kagawa-ken
    • Hiragi, Kagawa-ken, Japan, 761-0793
      • Recruiting
      • Site 127
  • Miyagi
    • Natori-shi, Miyagi, Japan, 981-1293
      • Recruiting
      • Site 174
    • Sendai, Miyagi, Japan, 960-8574
      • Recruiting
      • Site 126
  • Osaka
    • Ōsaka-sayama, Osaka, Japan, 589-8511
      • Recruiting
      • Site 125
  • Tokyo
    • Chuo Ku, Tokyo, Japan, 104-0045
      • Recruiting
      • Site 124
    • Minato-Ku, Tokyo, Japan, 105-8471
      • Recruiting
      • Site 188
• Lithuania
  • Kaunas, Lithuania, 50161
    • Recruiting
    • Site 183
  • Vilnius, Lithuania, 08406
    • Recruiting
    • Site 179
• Malaysia
  • Johor Bahru, Malaysia, 81100
    • Recruiting
    • Site 163
  • Kuching, Malaysia, 93586
    • Recruiting
    • Site 159
  • Putrajaya, Malaysia, 62250
    • Recruiting
    • Site 161
• Mexico
  • Chihuahua City, Mexico, 31000
    • Recruiting
    • Site 201
  • Guadalajara, Mexico, 44680
    • Recruiting
    • Site 200
  • Mexico City, Mexico, 06100
    • Recruiting
    • Site 202
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Recruiting
    • Site 84
  • Nijmegen, Netherlands, 6525 GA
    • Recruiting
    • Site 58
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Site 68
• Poland
  • Bydgoszcz, Poland, 85-796
    • Recruiting
    • Site 150
  • Gdansk, Poland, 80-214
    • Recruiting
    • Site 131
  • Gliwice, Poland, 44-102
    • Recruiting
    • Site 106
  • Krakow, Poland, 31-826
    • Recruiting
    • Site 116
  • Lodz, Poland, 93-513
    • Recruiting
    • Site 190
  • Warsaw, Poland, 02-781
    • Recruiting
    • Site 158
• Portugal
  • Coimbra, Portugal, 3004-561
    • Recruiting
    • Site 172
  • Lisbon, Portugal, 1998-018
    • Recruiting
    • Site 182
  • Portimão, Portugal, 8500-338
    • Recruiting
    • Site 181
  • Porto, Portugal, 4200-072
    • Recruiting
    • Site 175
  • Vila Real, Portugal, 5000-508
    • Recruiting
    • Site 203
• South Korea
  • Busan, South Korea, 48108
    • Recruiting
    • Site 145
  • Goyang-si, South Korea, 10408
    • Recruiting
    • Site 13
  • Gyeonggi-do, South Korea, 13496
    • Withdrawn
    • Site 47
  • Hwasun, South Korea, 58128
    • Recruiting
    • Site 51
  • Seoul, South Korea, 03722
    • Recruiting
    • Site 28
  • Seoul, South Korea, 03722
    • Recruiting
    • Site 35
  • Seoul, South Korea, 05505
    • Recruiting
    • Site 45
  • Suwon, South Korea, 16247
    • Recruiting
    • Site 42
  • Suwon, South Korea, 16499
    • Recruiting
    • Site 157
• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Site 120
  • Barcelona, Spain, 08035
    • Recruiting
    • Site 80
  • Madrid, Spain, 28040
    • Recruiting
    • Site 75
  • Madrid, Spain, 28041
    • Recruiting
    • Site 67
  • Madrid, Spain, 28040
    • Recruiting
    • Site 128
  • Madrid, Spain, 28050
    • Recruiting
    • Site 160
  • Marbella, Spain, 29660
    • Recruiting
    • Site 73
  • Pamplona, Spain, 31008
    • Recruiting
    • Site 61
  • Pamplona, Spain, 31008
    • Recruiting
    • Site 62
  • Valencia, Spain, 46009
    • Recruiting
    • Site 74
• Taiwan
  • Changhua, Taiwan, 500
    • Recruiting
    • Site 41
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Site 4
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Site 103
  • Taichung, Taiwan, 40447
    • Recruiting
    • Site 52
  • Taipei, Taiwan, 100
    • Recruiting
    • Site 39
  • Taipei, Taiwan, 112
    • Recruiting
    • Site 33
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Site 49
• Thailand
  • Chiang Rai, Thailand, 57000
    • Recruiting
    • Site 146
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Recruiting
      • Site 114
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • Site 107
    • Ratchathewi, Bangkok, Thailand, 10400
      • Recruiting
      • Site 65
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Recruiting
      • Site 77
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Site 184
  • Ankara, Turkey (Türkiye), 06170
    • Recruiting
    • Site 196
  • Antalya, Turkey (Türkiye), 07025
    • Recruiting
    • Site 176
  • Istanbul, Turkey (Türkiye), 34722
    • Recruiting
    • Site 193
  • Istanbul, Turkey (Türkiye), 34010
    • Recruiting
    • Site 198
• United Kingdom
  • Cambridge, United Kingdom, CB20QQ
    • Recruiting
    • Site 102
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Site 169
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Site 69
  • London, United Kingdom, SE19RT
    • Recruiting
    • Site 90
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • Site 132
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Site 173
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Site 177
  • Northwood, United Kingdom, HA62RN
    • Recruiting
    • Site 83
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Site 147
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Site 70
  • Taunton, United Kingdom, TA1 5DA
    • Recruiting
    • Site 135
• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Recruiting
      • Site 164
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Site 36
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Site 27
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Site 16
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Site 19
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Site 108
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Site 14
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Site 8
    • Orlando, Florida, United States, 32804
      • Withdrawn
      • Site 48
    • St. Petersburg, Florida, United States, 33705
      • Recruiting
      • Site 21
    • West Palm Beach, Florida, United States, 33401
      • Recruiting
      • Site 20
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Site 171
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • Site 50
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Site 197
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Site 2
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Site 162
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Site 155
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Recruiting
      • Site 168
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Site 94
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • Site 6
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Site 113
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Site 118
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Site 191
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Site 43
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Site 153
    • Philadelphia, Pennsylvania, United States, 19114
      • Recruiting
      • Site 154
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Recruiting
      • Site 89
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • Site 115
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Site 88
  • Texas
    • Austin, Texas, United States, 78745
      • Recruiting
      • Site 22
    • Houston, Texas, United States, 77030
      • Recruiting
      • Site 1
    • Plano, Texas, United States, 75075
      • Recruiting
      • Site 18
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Site 17
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Site 15
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Site 10
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Recruiting
      • Site 12
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Site 23

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed ICF before initiation of any study procedures
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% 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:

1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization
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 petosemtamab 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)

Other protocol defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Petosemtamab + Pembrolizumab; Combination Therapy	Drug: Petosemtamab; MCLA-158; Drug: Pembrolizumab; Humanized Antibody
Active Comparator: Pembrolizumab; Monotherapy	Drug: Pembrolizumab; Humanized Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to approximately 3 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR	Up to approximately 2 years
Duration of Response (DOR) per RECIST v1.1 as assessed by BICR	Up to approximately 2 years
Objective response rate per RECIST v1.1 as assessed by investigator review	Up to approximately 2 years
Progression-free survival per RECIST v1.1 as assessed by investigator review	Up to approximately 2 years
Duration of response per RECIST v1.1 as assessed by investigator review	Up to approximately 2 years
Clinical benefit rate per RECIST v1.1 as assessed by BICR	Up to approximately 2 years
Clinical benefit rate per RECIST v1.1 as assessed by investigator review	Up to approximately 2 years
Number of participants who experienced at least one treatment emergent adverse event (TEAE)	Up to 30 days post last dose
Number of participants who experienced at least one serious TEAE	Up to 30 days post last dose
Number of participants who discontinued study treatment due to TEAEs	Up to 30 days post last dose
Number of participants who had dose modification due to TEAEs	Up to 30 days post last dose
To evaluate patient reported outcomes for health-related quality of life	Up to approximately 2 years
Pharmacokinetic parameters	Up to first 6 cycles
Incidence of anti-drug antibodies (ADAs)	Up to 30 days post last dose
Time to response (TTR) per RECIST v1.1 as assessed by BICR	Time Frame: Up to approximately 2 years
Time to response (TTR) per RECIST v1.1 as assessed by Investigator	Time Frame: Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Merus B.V.

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pembrolizumab; HNSCC; Larynx; Head and Neck cancer; Hypopharynx; Oral Cavity; Oropharynx; PD-L1+; Petosemtamab; Liger
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Laryngeal Diseases; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab
• Other Study ID Numbers: MCLA-158-CL03; 2023-510323-30-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No