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Head and Neck Squamous Cell CarcinomaPhase 3NCT06525220

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 study testing Petosemtamab and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by Merus B.V. at 202 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Petosemtamab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
699 participants
Where
202 sitesin 28 countries
Study dates
25 Sep 2024to Jul 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed ICF before initiation of any study procedures
  • Age ≥ 18 years at signing of ICF
  • Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
  • The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
  • HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.
  • HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting
Show all 13Show fewer
  • A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
  • Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
  • ECOG Performance Status (PS) of 0-1
  • Life expectancy ≥ 12 weeks, as per investigator assessment.
  • Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
  • Adequate organ function as defined per protocol.
  • 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

Who cannot join

  • 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
  • Known leptomeningeal involvement
  • Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
  • Requirement for immunosuppressive medication
  • Major surgery or radiotherapy within 3 weeks of randomization
  • 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
Show all 18Show fewer
  • History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab.
  • 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
  • History of prior malignancies within the last 5 years, with the exception of excised local 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
  • Patients with known infectious diseases as per protocol.
  • Pregnant or breastfeeding patients.
  • 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
  • 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
  • The patient has had an allogeneic tissue/solid organ transplant.
  • Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)
  • Other protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

202 sites in 28 countries.

202 sites in 28 countries

United States36 sites

  • Site 6

    Albuquerque, New Mexico, 87131

  • Site 171

    Atlanta, Georgia, 30322

  • Site 22

    Austin, Texas, 78745

  • Site 162

    Baton Rouge, Louisiana, 70809

  • Site 12

    Blacksburg, Virginia, 24060

  • Site 89

    Chattanooga, Tennessee, 37404

  • Site 197

    Chicago, Illinois, 60611

  • Site 50

    Chicago, Illinois, 60637

  • Site 191

    Cleveland, Ohio, 44195

  • Site 113

    Durham, North Carolina, 27710

  • Site 14

    Fort Myers, Florida, 33901

  • Site 94

    Hackensack, New Jersey, 07601

  • Site 1

    Houston, Texas, 77030

  • Site 36

    La Jolla, California, 92037

  • Site 27

    Los Angeles, California, 90033

  • Site 2

    Louisville, Kentucky, 40202

  • Site 115

    Memphis, Tennessee, 38103

  • Site 155

    Minneapolis, Minnesota, 55417

  • Site 164

    Mobile, Alabama, 36607

  • Site 88

    Nashville, Tennessee, 37203

  • Site 19

    Newark, Delaware, 19713

  • Site 23

    Norfolk, Virginia, 23502

  • Site 8

    Orlando, Florida, 32827

  • Site 16

    Palo Alto, California, 94304

  • Site 43

    Philadelphia, Pennsylvania, 19104

  • Site 153

    Philadelphia, Pennsylvania, 19107

  • Site 154

    Philadelphia, Pennsylvania, 19114

  • Site 18

    Plano, Texas, 75075

  • Site 10

    Salt Lake City, Utah, 84112

  • Site 168

    St Louis, Missouri, 63108

  • Site 21

    St. Petersburg, Florida, 33705

  • Site 17

    Sugar Land, Texas, 77479

  • Site 15

    Tyler, Texas, 75702

  • Site 108

    Washington D.C., District of Columbia, 20010

  • Site 20

    West Palm Beach, Florida, 33401

  • Site 118

    Winston-Salem, North Carolina, 27157

Other trials in United States

France14 sites

  • Site 56

    Bordeaux, 33075

  • Site 101

    Le Mans, 72000

  • Site 79

    Lille, 59000

  • Site 72

    Lyon, 69378

  • Site 57

    Marseille, 13005

  • Site 55

    Montpellier, 34298

  • Site 66

    Nice, 06189

  • Site 105

    Paris, 75005

  • Site 143

    Paris, 75013

  • Site 87

    Poitiers, 86021

  • Site 54

    Rouen, 76038

  • Site 59

    Toulouse, 31100

  • Site 64

    Vandœuvre-lès-Nancy, 54519

  • Site 112

    Villejuif, 94800

Other trials in France

Germany13 sites

  • Site 133

    Bonn, 53175

  • Site 178

    Dortmund, 44137

  • Site 100

    Dresden, 01307

  • Site 60

    Greifswald, 17475

  • Site 82

    Hamburg, 20251

  • Site 91

    Hamburg, 22763

  • Site 104

    Hanover, 30625

  • Site 129

    Mannheim, 68167

  • Site 148

    München, 81675

  • Site 121

    Münster, 48149

  • Site 78

    Tübingen, 72076

  • Site 130

    Ulm, 89075

  • Site 110

    Würzburg, 97080

Other trials in Germany

United Kingdom11 sites

  • Site 102

    Cambridge, CB20QQ

  • Site 169

    Cardiff, CF14 2TL

  • Site 132

    London, EC1A 7BE

  • Site 90

    London, SE19RT

  • Site 69

    London, SW3 6JJ

  • Site 173

    Manchester, M20 4BX

  • Site 177

    Newcastle upon Tyne, NE7 7DN

  • Site 83

    Northwood, HA62RN

  • Site 147

    Southampton, SO16 6YD

  • Site 70

    Sutton, SM2 5PT

  • Site 135

    Taunton, TA1 5DA

Other trials in United Kingdom

Italy10 sites

  • Site 86

    Ancona, 60126

  • Site 97

    Brescia, 25123

  • Site 180

    Cagliari, 09121

  • Site 139

    Meldola, 47014

  • Site 122

    Milan, 20133

  • Site 81

    Milan, 20141

  • Site 152

    Naples, 80131

  • Site 93

    Naples, 80131

  • Site 186

    Rome, 00161

  • Site 85

    Rozzano, 20089

Other trials in Italy

Spain10 sites

  • Site 120

    Badalona, 08916

  • Site 80

    Barcelona, 08035

  • Site 128

    Madrid, 28040

  • Site 75

    Madrid, 28040

  • Site 67

    Madrid, 28041

  • Site 160

    Madrid, 28050

  • Site 73

    Marbella, 29660

  • Site 61

    Pamplona, 31008

  • Site 62

    Pamplona, 31008

  • Site 74

    Valencia, 46009

Other trials in Spain

Brazil9 sites

  • Site 141

    Belo Horizonte, 30.360-680

  • Site 144

    Natal, 59020-340

  • Site 140

    Porto Alegre, 90610-000

  • Site 142

    Porto Alegre, 91350-200

  • Site 137

    Recife, 50040-000

  • Site 149

    Rio de Janeiro, 22.250-905

  • Site 138

    Rio de Janeiro, 22281-100

  • Site 134

    São Paulo, 01509-900

  • Site 136

    São Paulo, 04538-132

Other trials in Brazil

Japan9 sites

  • Site 124

    Chuo Ku, Tokyo, 104-0045

  • Site 185

    Fukuoka, Fukuoka, 810-8563

  • Site 127

    Hiragi, Kagawa-ken, 761-0793

  • Site 123

    Kashiwa, Chiba, 277-8577

  • Site 188

    Minato-Ku, Tokyo, 105-8471

  • Site 167

    Nagoya, Aichi-ken, 464-8681

  • Site 174

    Natori-shi, Miyagi, 981-1293

  • Site 125

    Ōsaka-sayama, Osaka, 589-8511

  • Site 126

    Sendai, Miyagi, 960-8574

Other trials in Japan

South Korea8 sites

  • Site 145

    Busan, 48108

  • Site 13

    Goyang-si, 10408

  • Site 51

    Hwasun, 58128

  • Site 28

    Seoul, 03722

  • Site 35

    Seoul, 03722

  • Site 45

    Seoul, 05505

  • Site 42

    Suwon, 16247

  • Site 157

    Suwon, 16499

Other trials in South Korea

Chile7 sites

  • Site 38

    Antofagasta, 1263521

  • Site 26

    Providencia, 7500859

  • Site 29

    Recoleta, 8420000

  • Site 40

    Santiago, 7500921

  • Site 32

    Santiago, 7560908

  • Site 34

    Santiago, 8330336

  • Site 25

    Temuco, 76281055-7

Other trials in Chile

Taiwan7 sites

  • Site 41

    Changhua, 500

  • Site 4

    Kaohsiung City, 80756

  • Site 103

    Kaohsiung City, 833

  • Site 52

    Taichung, 40447

  • Site 39

    Taipei, 100

  • Site 33

    Taipei, 112

  • Site 49

    Taoyuan City, 333

Other trials in Taiwan

Argentina6 sites

  • Site 170

    CABA, C1113AAE

  • Site 96

    CABA, C1118AAT

  • Site 31

    Córdoba, X5008HHW

  • Site 30

    La Rioja, 5300

  • Site 76

    Rosario, S2000KZE

  • Site 46

    Viedma, R8500ACE

Other trials in Argentina

Belgium6 sites

  • Site 53

    Brussels, 1200

  • Site 98

    Edegem, 2650

  • Site 99

    Ghent, 9000

  • Site 71

    Leuven, 3000

  • Site 109

    Liège, 4000

  • Site 63

    Namur, 5000

Other trials in Belgium

Poland6 sites

  • Site 150

    Bydgoszcz, 85-796

  • Site 131

    Gdansk, 80-214

  • Site 106

    Gliwice, 44-102

  • Site 116

    Krakow, 31-826

  • Site 190

    Lodz, 93-513

  • Site 158

    Warsaw, 02-781

Other trials in Poland

Greece5 sites

  • Site 156

    Athens, Attica, 151 23

  • Site 95

    Chaïdári, 12462

  • Site 117

    Heraklion, Crete, 715 00

  • Site 92

    Panórama, 55236

  • Site 119

    Pátrai, Achaia, 265 04

Other trials in Greece

Portugal5 sites

  • Site 172

    Coimbra, 3004-561

  • Site 182

    Lisbon, 1998-018

  • Site 181

    Portimão, 8500-338

  • Site 175

    Porto, 4200-072

  • Site 203

    Vila Real, 5000-508

Other trials in Portugal

Thailand5 sites

  • Site 114

    Bangkok Noi, Bangkok, 10700

  • Site 146

    Chiang Rai, 57000

  • Site 77

    Hat Yai, Changwat Songkhla, 90110

  • Site 107

    Pathum Wan, Bangkok, 10330

  • Site 65

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

Turkey (Türkiye)5 sites

  • Site 196

    Ankara, 06170

  • Site 184

    Ankara, 06230

  • Site 176

    Antalya, 07025

  • Site 198

    Istanbul, 34010

  • Site 193

    Istanbul, 34722

Other trials in Turkey (Türkiye)

Australia4 sites

  • Site 11

    Blacktown, New South Wales, 2148

  • Site 166

    Greenslopes, Queensland, 4120

  • Site 151

    Melbourne, Victoria, 3004

  • Site 24

    St Leonards, New South Wales, 2065

Other trials in Australia

Israel4 sites

  • Site 9

    Haifa, 3109601

  • Site 5

    Jerusalem, 9112001

  • Site 3

    Ramat Gan, 5266202

  • Site 7

    Tel Aviv, 6423906

Other trials in Israel

Canada3 sites

  • Site 165

    St. John's, A1B3V6

  • Site 44

    Toronto, M5G 2M9

  • Site 111

    Winnipeg, R3E0V9

Other trials in Canada

Croatia3 sites

  • Site 205

    Osijek, 31000

  • Site 199

    Split, 21000

  • Site 204

    Zagreb, 10000

Other trials in Croatia

Hungary3 sites

  • Site 194

    Nyíregyháza, 4400

  • Site 189

    Pécs, 7624

  • Site 187

    Szeged, 6720

Other trials in Hungary

Malaysia3 sites

  • Site 163

    Johor Bahru, 81100

  • Site 159

    Kuching, 93586

  • Site 161

    Putrajaya, 62250

Other trials in Malaysia

Mexico3 sites

  • Site 201

    Chihuahua City, 31000

  • Site 200

    Guadalajara, 44680

  • Site 202

    Mexico City, 06100

Other trials in Mexico

Netherlands3 sites

  • Site 84

    Amsterdam, 1066 CX

  • Site 58

    Nijmegen, 6525 GA

  • Site 68

    Utrecht, 3584 CX

Other trials in Netherlands

Czechia2 sites

  • Site 195

    Olomouc, 779 00

  • Site 192

    Prague, 150 06

Other trials in Czechia

Lithuania2 sites

  • Site 183

    Kaunas, 50161

  • Site 179

    Vilnius, 08406

Other trials in Lithuania

About this study

Official title: 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.

Read the 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.

Being tested
Petosemtamab, Pembrolizumab
Keywords
HNSCC, PD-L1+, Head and Neck cancer, Petosemtamab, Pembrolizumab, Liger, Oral Cavity, Oropharynx, Larynx, Hypopharynx
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06525220
Study groupRoleWhat they receive
Petosemtamab + PembrolizumabExperimentalCombination Therapy
Receives: Drug: Petosemtamab; Drug: Pembrolizumab
PembrolizumabActive comparatorMonotherapy
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: Up to approximately 3 years

  2. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)

    Measured: Up to approximately 2 years

Secondary outcomes (16)

  1. Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR

    Measured: Up to approximately 2 years

  2. Duration of Response (DOR) per RECIST v1.1 as assessed by BICR

    Measured: Up to approximately 2 years

  3. Clinical benefit rate per RECIST v1.1 as assessed by BICR

    Measured: Up to approximately 2 years

  4. Time to response (TTR) per RECIST v1.1 as assessed by BICR

    Measured: Time Frame: Up to approximately 2 years

  5. Objective response rate per RECIST v1.1 as assessed by investigator review

    Measured: Up to approximately 2 years

  6. Progression-free survival per RECIST v1.1 as assessed by investigator review

    Measured: Up to approximately 2 years

  7. Duration of response per RECIST v1.1 as assessed by investigator review

    Measured: Up to approximately 2 years

  8. Time to response (TTR) per RECIST v1.1 as assessed by Investigator

    Measured: Time Frame: Up to approximately 2 years

  9. Clinical benefit rate per RECIST v1.1 as assessed by investigator review

    Measured: Up to approximately 2 years

  10. Number of participants who experienced at least one treatment emergent adverse event (TEAE)

    Measured: Up to 30 days post last dose

  11. Number of participants who experienced at least one serious TEAE

    Measured: Up to 30 days post last dose

  12. Number of participants who discontinued study treatment due to TEAEs

    Measured: Up to 30 days post last dose

  13. Number of participants who had dose modification due to TEAEs

    Measured: Up to 30 days post last dose

  14. To evaluate patient reported outcomes for health-related quality of life

    Measured: Up to approximately 2 years

  15. Pharmacokinetic parameters

    Measured: Up to first 6 cycles

  16. Incidence of anti-drug antibodies (ADAs)

    Measured: Up to 30 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start25 Sep 2024
  3. Primary completionJan 2028 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
699 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525220
Sponsor's protocol ID
MCLA-158-CL03
Other IDs
2023-510323-30-00, 2023
Status last verified
Sep 2026
First submitted
24 Jul 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 40511820

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Petosemtamab and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by Merus B.V. at 202 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 202 sites in United States, France, Germany, United Kingdom, Italy and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06525220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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