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Head and Neck Squamous Cell CarcinomaPhase 3NCT06496178

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 study testing Petosemtamab and Investigator's Choice in people with Head and Neck Squamous Cell Carcinoma, run by Merus B.V. at 193 sites in 24 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 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. 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 Investigator's Choice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
621 participants
Where
193 sitesin 24 countries
Study dates
25 Jun 2024to Mar 2029
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 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.
Show all 10Show fewer
  • 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)

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

193 sites in 24 countries.

193 sites in 24 countries

United States60 sites

  • Site 15

    Albuquerque, New Mexico, 87131

  • Site 103

    Ann Arbor, Michigan, 48109

  • Site 187

    Atlanta, Georgia, 30322

  • Site 40

    Baton Rouge, Louisiana, 70809

  • Site 151

    Bensalem, Pennsylvania, 19020

  • Site 10

    Blacksburg, Virginia, 24060

  • Site 77

    Boston, Massachusetts, 02215

  • Site 98

    Chapel Hill, North Carolina, 27514

  • Site 50

    Charleston, South Carolina, 29425

  • Site 22

    Charlottesville, Virginia, 22908

  • Site 60

    Chattanooga, Tennessee, 37404

  • Site 152

    Chicago, Illinois, 60607

  • Site 213

    Chicago, Illinois, 60611

  • Site 68

    Chicago, Illinois, 60637

  • Site 23

    Cincinnati, Ohio, 45219

  • Site 218

    Cleveland, Ohio, 44106

  • Site 87

    Cleveland, Ohio, 44195

  • Site 153

    Columbia, Maryland, 21044

  • Site 32

    Columbus, Ohio, 43210

  • Site 55

    Denison, Texas, 75020

  • Site 5

    Detroit, Michigan, 48201

  • Site 82

    Duarte, California, 91010

  • Site 122

    Durham, North Carolina, 27710

  • Site 34

    El Paso, Texas, 79915

  • Site 12

    Fort Myers, Florida, 33901

  • Site 86

    Hackensack, New Jersey, 07601

  • Site 51

    Houston, Texas, 77030

  • Site 7

    Houston, Texas, 77030

  • Site 31

    Indianapolis, Indiana, 46202

  • Site 123

    Jacksonville, Florida, 32224

  • Site 25

    La Jolla, California, 92037

  • Site 130

    Lone Tree, Colorado, 80124

  • Site 8

    Louisville, Kentucky, 40202

  • Site 216

    Madison, Wisconsin, 53705

  • Site 49

    Maple Grove, Minnesota, 55369

  • Site 54

    Memphis, Tennessee, 38103

  • Site 160

    Mobile, Alabama, 36608

  • Site 59

    Nashville, Tennessee, 37203

  • Site 67

    Nashville, Tennessee, 37232

  • Site 100

    New Orleans, Louisiana, 70121

  • Site 24

    New York, New York, 10029

  • Site 173

    Orange, California, 92868

  • Site 9

    Orlando, Florida, 32827

  • Site 28

    Palo Alto, California, 94304

  • Site 94

    Pearland, Texas, 77584

  • Site 158

    Philadelphia, Pennsylvania, 19107

  • Site 26

    Portland, Oregon, 97213

  • Site 102

    Prescott, Arizona, 86301

  • Site 124

    Rochester, Minnesota, 55905

  • Site 127

    Sacramento, California, 95817

  • Site 4

    Salt Lake City, Utah, 84112

  • Site 46

    San Francisco, California, 94158

  • Site 125

    Scottsdale, Arizona, 85054

  • Site 163

    Seattle, Washington, 98109

  • Site 6

    Spokane, Washington, 99202

  • Site 18

    St Louis, Missouri, 63110

  • Site 138

    Tampa, Florida, 33612

  • Site 214

    The Bronx, New York, 10461

  • Site 104

    Washington D.C., District of Columbia, 20010

  • Site 156

    Winchester, Virginia, 22601

Other trials in United States

France16 sites

  • Site 105

    Bordeaux, 33075

  • Site 211

    Brest, 29200

  • Site 162

    Le Mans, 72000

  • Site 149

    Lille, 59000

  • Site 118

    Lyon, 69373

  • Site 115

    Marseille, 13005

  • Site 106

    Montpellier, 34298

  • Site 169

    Nice, 06189

  • Site 114

    Paris, 75005

  • Site 167

    Paris, 75013

  • Site 136

    Poitiers, 86000

  • Site 141

    Rennes, 35042

  • Site 107

    Rouen, 76038

  • Site 119

    Toulouse, 31059

  • Site 142

    Vandœuvre-lès-Nancy, 54519

  • Site 113

    Villejuif, 94800

Other trials in France

United Kingdom12 sites

  • Site 65

    Cambridge, CB2 0QQ

  • Site 174

    Cardiff, CF14 2TL

  • Site 171

    Glasgow, G12 0YN

  • Site 44

    Liverpool, L7 8YA

  • Site 157

    London, E20 1JQ

  • Site 140

    London, EC1A 7BE

  • Site 90

    London, SE1 9RT

  • Site 42

    London, SW3 6JJ

  • Site 48

    Manchester, M20 4BX

  • Site 70

    Middlesex, HA6 2RN

  • Site 191

    Newcastle upon Tyne, NE7 7DN

  • Site 43

    Sutton, SM2 5PT

Other trials in United Kingdom

Germany9 sites

  • Site 121

    Berlin, 12203

  • Site 210

    Dresden, 01307

  • Site 165

    Essen, 45147

  • Site 84

    Giessen, 35390

  • Site 62

    Greifswald, 17475

  • Site 112

    Hanover, 30625

  • Site 116

    Leipzig, 04103

  • Site 168

    München, 81675

  • Site 99

    Würzburg, 97080

Other trials in Germany

Italy8 sites

  • Site 93

    Brescia, 25123

  • Site 111

    Cuneo, 12100

  • Site 128

    Milan, 20133

  • Site 81

    Milan, 20141

  • Site 209

    Naples, 80131

  • Site 89

    Naples, 80131

  • Site 203

    Roma, 00161

  • Site 85

    Rozzano, 20089

Other trials in Italy

Japan8 sites

  • Site 132

    Chūōku, 104-0045

  • Site 192

    Fukuoka, 812-8582

  • Site 131

    Kashiwa, 277-8577

  • Site 135

    Miki, 761-0793

  • Site 139

    Nagoya, 464-8681

  • Site 186

    Natori, 981-1293

  • Site 133

    Ōsaka-sayama, 589-8511

  • Site 134

    Sendai, 980-8574

Other trials in Japan

South Korea8 sites

  • Site 161

    Busan, 48108

  • Site 13

    Goyang-si, 10408

  • Site 29

    Hwasun, 58128

  • Site 137

    Seoul, 03080

  • Site 36

    Seoul, 05505

  • Site 47

    Seoul, 06351

  • Site 33

    Soeul, 03722

  • Site 164

    Suwon, 16499

Other trials in South Korea

Spain8 sites

  • Site 78

    Barcelona, 08035

  • Site 109

    Madrid, 28040

  • Site 75

    Madrid, 28040

  • Site 71

    Madrid, 28041

  • Site 166

    Madrid, 28050

  • Site 63

    Pamplona, 31008

  • Site 64

    Pamplona, 31008

  • Site 74

    Valencia, 46009

Other trials in Spain

Brazil7 sites

  • Site 154

    Brasília, 70390-140

  • Site 145

    Porto Alegre, 90110-270

  • Site 150

    Porto Alegre, 90610-000

  • Site 146

    Recife, 50040-000

  • Site 148

    Rio de Janeiro, 22281-100

  • Site 147

    São Paulo, 01509-900

  • Site 144

    São Paulo, 04538-132

Other trials in Brazil

Poland7 sites

  • Site 190

    Bydgoszcz, 85-796

  • Site 143

    Gdansk, 80-214

  • Site 97

    Gliwice, 44-102

  • Site 177

    Krakow, 31-826

  • Site 200

    Lodz, 93-513

  • Site 117

    Poznan, 60-185

  • Site 179

    Warsaw, 02-781

Other trials in Poland

Australia6 sites

  • Site 3

    Darlinghurst, 2010

  • Site 170

    Herston, 4060

  • Site 38

    Melbourne, 3000

  • Site 30

    Nedlands, 6009

  • Site 11

    Saint Leonards, 2065

  • Site 73

    Sydney, 2050

Other trials in Australia

Taiwan6 sites

  • Site 17

    Kaohsiung City, 807

  • Site 95

    Kaohsiung City, 833

  • Site 53

    Taichung, 40447

  • Site 176

    Tainan, 70428

  • Site 35

    Taipei, 112

  • Site 52

    Taoyuan City, 333

Other trials in Taiwan

Belgium5 sites

  • Site 56

    Brussels, 1200

  • Site 92

    Ghent, 9000

  • Site 72

    Leuven, 3000

  • Site 108

    Liège, 4000

  • Site 69

    Namur, 5000

Other trials in Belgium

Argentina4 sites

  • Site 58

    Caba, C1280AEB

  • Site 45

    Córdoba, X5008HHW

  • Site 110

    Rosario, S2000KZE

  • Site 57

    Viedma, 8500

Other trials in Argentina

Chile4 sites

  • Site 16

    Providencia, 7500859

  • Site 20

    Recoleta, 8420000

  • Site 27

    Santiago, 7500921

  • Site 21

    Santiago, 7560908

Other trials in Chile

Israel4 sites

  • Site 19

    Haifa, 3109601

  • Site 1

    Jerusalem, 9112001

  • Site 14

    Ramat Gan, 5265601

  • Site 2

    Tel Aviv, 6423906

Other trials in Israel

Switzerland4 sites

  • Site 184

    Bellinzona, CH-6500

  • Site 189

    Geneva, 1211

  • Site 194

    Lausanne, 1011

  • Site 178

    Sankt Gallen, 9007

Other trials in Switzerland

Greece3 sites

  • Site 91

    Athens, 124 62

  • Site 120

    Heraklion, 71500

  • Site 83

    Thessaloniki, 55236

Other trials in Greece

Hungary3 sites

  • Site 204

    Nyíregyháza, 4400

  • Site 195

    Pécs, 7624

  • Site 198

    Szeged, 6725

Other trials in Hungary

Netherlands3 sites

  • Site 76

    Amsterdam, 1066 CX

  • Site 61

    Nijmegen, 6525 GA

  • Site 66

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal3 sites

  • Site 182

    Coimbra, 3004-561

  • Site 183

    Lisbon, 1998-018

  • Site 185

    Porto, 4200-072

Other trials in Portugal

Canada2 sites

  • Site 172

    Montreal, H2X 0A9

  • Site 196

    Toronto, M4N 3M5

Other trials in Canada

Lithuania2 sites

  • Site 180

    Kaunas, 50161

  • Site 181

    Vilnius, 08406

Other trials in Lithuania

Czechia1 site

  • Site 201

    Olomouc, 779 00

Other trials in Czechia

About this study

Official title: 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

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.

Read the 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.

Being tested
Petosemtamab, Investigator's Choice
Keywords
HNSCC
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • PetosemtamabDrug

    MCLA-158

  • Investigator's ChoiceDrug

    Cetuximab

  • Investigator's ChoiceDrug

    Methotrexate

  • Investigator's ChoiceDrug

    Docetaxel

Study groups in NCT06496178
Study groupRoleWhat they receive
MCLA-158ExperimentalNot described
Receives: Drug: Petosemtamab
Investigator's ChoiceActive comparatorNot described
Receives: Drug: Investigator's Choice

What is being measured

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

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 3 years

Secondary outcomes (15)

  1. Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review

    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.

    Measured: Up to approximately 2 years

  2. Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review

    PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.

    Measured: Up to approximately 2 years

  3. Duration of Response (DOR) as Assessed by Blinded Independent Central Review

    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.

    Measured: Up to approximately 2 years

  4. Objective Response Rate (ORR) as Assessed by Investigator Review

    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.

    Measured: Up to approximately 2 years

  5. Progression Free Survival (PFS) as Assessed by Investigator Review

    PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.

    Measured: Up to approximately 2 years

  6. Duration of Response (DOR) as Assessed by Investigator Review

    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.

    Measured: Up to approximately 2 years

  7. Time to Response (TTR) as Assessed by Blinded Independent Central Review

    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.

    Measured: Up to approximately 2 years

  8. Time to Response (TTR) as Assessed by Investigator Review

    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.

    Measured: Up to approximately 2 years

  9. Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review

    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

    Measured: Up to approximately 2 years

  10. Clinical Benefit Rate (CBR) as Assessed by Investigator Review

    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

    Measured: Up to approximately 2 years

  11. Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE)

    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.

    Measured: Up to 30 days post-last dose

  12. Number of Participants who Experienced At Least One Serious TEAE

    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.

    Measured: Up to 30 days post-last dose

  13. Number of Participants who Discontinued Study Treatment Due to TEAEs

    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.

    Measured: Up to 30 days post-last dose

  14. Number of Participants who had Dose Modification Due to TEAEs

    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.

    Measured: Up to 30 days post-last dose

  15. Pharmacokinetic parameters

    Clearance of plasma and central volume of distribution based on population PK model

    Measured: Up to first 6 cycles

Timeline

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

  1. First posted11 Jul 2024
  2. Study start25 Jun 2024
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMar 2029 (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
621 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06496178
Sponsor's protocol ID
MCLA-158-CL02
Other IDs
2023-510322-32-00, 2023
Status last verified
Aug 2026
First submitted
3 Jul 2024
Last updated
19 Oct 2026
Results posted
No
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 Investigator's Choice in people with Head and Neck Squamous Cell Carcinoma, run by Merus B.V. at 193 sites in 24 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 10 inclusion and 12 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, France, United Kingdom, Germany, Italy and 19 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). 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 NCT06496178, 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 19 Oct 2026.

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