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New combo therapy aims to boost survival in head and neck cancer

NCT ID NCT06525220

Disease control Sponsor: Merus B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding petosemtamab to the standard immunotherapy pembrolizumab helps people with advanced head and neck cancer live longer. About 700 adults with PD-L1 positive cancer that has spread or come back will receive either the combination or pembrolizumab alone. The goal is to see if the combination improves overall survival and tumor shrinkage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma laryngeal disorder Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    202 sites in 28 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Site 1

    RECRUITING

    Houston, Texas, 77030, United States

  • Site 10

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Site 100

    RECRUITING

    Dresden, 01307, Germany

  • Site 101

    RECRUITING

    Le Mans, 72000, France

  • Site 102

    RECRUITING

    Cambridge, CB20QQ, United Kingdom

  • Site 103

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Site 104

    RECRUITING

    Hanover, 30625, Germany

  • Site 105

    RECRUITING

    Paris, 75005, France

  • Site 106

    RECRUITING

    Gliwice, 44-102, Poland

  • Site 107

    RECRUITING

    Pathum Wan, Bangkok, 10330, Thailand

  • Site 108

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Site 109

    RECRUITING

    Liège, 4000, Belgium

  • Site 11

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • Site 110

    RECRUITING

    Würzburg, 97080, Germany

  • Site 111

    RECRUITING

    Winnipeg, R3E0V9, Canada

  • Site 112

    RECRUITING

    Villejuif, 94800, France

  • Site 113

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Site 114

    RECRUITING

    Bangkok Noi, Bangkok, 10700, Thailand

  • Site 115

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Site 116

    RECRUITING

    Krakow, 31-826, Poland

  • Site 117

    RECRUITING

    Heraklion, Crete, 715 00, Greece

  • Site 118

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Site 119

    RECRUITING

    Pátrai, Achaia, 265 04, Greece

  • Site 12

    RECRUITING

    Blacksburg, Virginia, 24060, United States

  • Site 120

    RECRUITING

    Badalona, 08916, Spain

  • Site 121

    RECRUITING

    Münster, 48149, Germany

  • Site 122

    RECRUITING

    Milan, 20133, Italy

  • Site 123

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Site 124

    RECRUITING

    Chuo Ku, Tokyo, 104-0045, Japan

  • Site 125

    RECRUITING

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Site 126

    RECRUITING

    Sendai, Miyagi, 960-8574, Japan

  • Site 127

    RECRUITING

    Hiragi, Kagawa-ken, 761-0793, Japan

  • Site 128

    RECRUITING

    Madrid, 28040, Spain

  • Site 129

    RECRUITING

    Mannheim, 68167, Germany

  • Site 13

    RECRUITING

    Goyang-si, 10408, South Korea

  • Site 130

    RECRUITING

    Ulm, 89075, Germany

  • Site 131

    RECRUITING

    Gdansk, 80-214, Poland

  • Site 132

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Site 133

    RECRUITING

    Bonn, 53175, Germany

  • Site 134

    RECRUITING

    São Paulo, 01509-900, Brazil

  • Site 135

    RECRUITING

    Taunton, TA1 5DA, United Kingdom

  • Site 136

    RECRUITING

    São Paulo, 04538-132, Brazil

  • Site 137

    RECRUITING

    Recife, 50040-000, Brazil

  • Site 138

    RECRUITING

    Rio de Janeiro, 22281-100, Brazil

  • Site 139

    RECRUITING

    Meldola, 47014, Italy

  • Site 14

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Site 140

    RECRUITING

    Porto Alegre, 90610-000, Brazil

  • Site 141

    RECRUITING

    Belo Horizonte, 30.360-680, Brazil

  • Site 142

    RECRUITING

    Porto Alegre, 91350-200, Brazil

  • Site 143

    RECRUITING

    Paris, 75013, France

  • Site 144

    RECRUITING

    Natal, 59020-340, Brazil

  • Site 145

    RECRUITING

    Busan, 48108, South Korea

  • Site 146

    RECRUITING

    Chiang Rai, 57000, Thailand

  • Site 147

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Site 148

    RECRUITING

    München, 81675, Germany

  • Site 149

    RECRUITING

    Rio de Janeiro, 22.250-905, Brazil

  • Site 15

    RECRUITING

    Tyler, Texas, 75702, United States

  • Site 150

    RECRUITING

    Bydgoszcz, 85-796, Poland

  • Site 151

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Site 152

    RECRUITING

    Naples, 80131, Italy

  • Site 153

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Site 154

    RECRUITING

    Philadelphia, Pennsylvania, 19114, United States

  • Site 155

    RECRUITING

    Minneapolis, Minnesota, 55417, United States

  • Site 156

    RECRUITING

    Athens, Attica, 151 23, Greece

  • Site 157

    RECRUITING

    Suwon, 16499, South Korea

  • Site 158

    RECRUITING

    Warsaw, 02-781, Poland

  • Site 159

    RECRUITING

    Kuching, 93586, Malaysia

  • Site 16

    RECRUITING

    Palo Alto, California, 94304, United States

  • Site 160

    RECRUITING

    Madrid, 28050, Spain

  • Site 161

    RECRUITING

    Putrajaya, 62250, Malaysia

  • Site 162

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Site 163

    RECRUITING

    Johor Bahru, 81100, Malaysia

  • Site 164

    RECRUITING

    Mobile, Alabama, 36607, United States

  • Site 165

    RECRUITING

    St. John's, A1B3V6, Canada

  • Site 166

    RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • Site 167

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Site 168

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Site 169

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Site 17

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Site 170

    RECRUITING

    CABA, C1113AAE, Argentina

  • Site 171

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Site 172

    RECRUITING

    Coimbra, 3004-561, Portugal

  • Site 173

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Site 174

    RECRUITING

    Natori-shi, Miyagi, 981-1293, Japan

  • Site 175

    RECRUITING

    Porto, 4200-072, Portugal

  • Site 176

    RECRUITING

    Antalya, 07025, Turkey (Türkiye)

  • Site 177

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Site 178

    RECRUITING

    Dortmund, 44137, Germany

  • Site 179

    RECRUITING

    Vilnius, 08406, Lithuania

  • Site 18

    RECRUITING

    Plano, Texas, 75075, United States

  • Site 180

    RECRUITING

    Cagliari, 09121, Italy

  • Site 181

    RECRUITING

    Portimão, 8500-338, Portugal

  • Site 182

    RECRUITING

    Lisbon, 1998-018, Portugal

  • Site 183

    RECRUITING

    Kaunas, 50161, Lithuania

  • Site 184

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Site 185

    RECRUITING

    Fukuoka, Fukuoka, 810-8563, Japan

  • Site 186

    RECRUITING

    Rome, 00161, Italy

  • Site 187

    RECRUITING

    Szeged, 6720, Hungary

  • Site 188

    RECRUITING

    Minato-Ku, Tokyo, 105-8471, Japan

  • Site 189

    RECRUITING

    Pécs, 7624, Hungary

  • Site 19

    RECRUITING

    Newark, Delaware, 19713, United States

  • Site 190

    RECRUITING

    Lodz, 93-513, Poland

  • Site 191

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Site 192

    RECRUITING

    Prague, 150 06, Czechia

  • Site 193

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Site 194

    RECRUITING

    Nyíregyháza, 4400, Hungary

  • Site 195

    RECRUITING

    Olomouc, 779 00, Czechia

  • Site 196

    RECRUITING

    Ankara, 06170, Turkey (Türkiye)

  • Site 197

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Site 198

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Site 199

    RECRUITING

    Split, 21000, Croatia

  • Site 2

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Site 20

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Site 200

    RECRUITING

    Guadalajara, 44680, Mexico

  • Site 201

    RECRUITING

    Chihuahua City, 31000, Mexico

  • Site 202

    RECRUITING

    Mexico City, 06100, Mexico

  • Site 203

    RECRUITING

    Vila Real, 5000-508, Portugal

  • Site 204

    RECRUITING

    Zagreb, 10000, Croatia

  • Site 205

    RECRUITING

    Osijek, 31000, Croatia

  • Site 21

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Site 22

    RECRUITING

    Austin, Texas, 78745, United States

  • Site 23

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Site 24

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Site 25

    RECRUITING

    Temuco, 76281055-7, Chile

  • Site 26

    RECRUITING

    Providencia, 7500859, Chile

  • Site 27

    RECRUITING

    Los Angeles, California, 90033, United States

  • Site 28

    RECRUITING

    Seoul, 03722, South Korea

  • Site 29

    RECRUITING

    Recoleta, 8420000, Chile

  • Site 3

    RECRUITING

    Ramat Gan, 5266202, Israel

  • Site 30

    RECRUITING

    La Rioja, 5300, Argentina

  • Site 31

    RECRUITING

    Córdoba, X5008HHW, Argentina

  • Site 32

    RECRUITING

    Santiago, 7560908, Chile

  • Site 33

    RECRUITING

    Taipei, 112, Taiwan

  • Site 34

    RECRUITING

    Santiago, 8330336, Chile

  • Site 35

    RECRUITING

    Seoul, 03722, South Korea

  • Site 36

    RECRUITING

    La Jolla, California, 92037, United States

  • Site 37

    WITHDRAWN

    CABA, C1125ABD, Argentina

  • Site 38

    RECRUITING

    Antofagasta, 1263521, Chile

  • Site 39

    RECRUITING

    Taipei, 100, Taiwan

  • Site 4

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Site 40

    RECRUITING

    Santiago, 7500921, Chile

  • Site 41

    RECRUITING

    Changhua, 500, Taiwan

  • Site 42

    RECRUITING

    Suwon, 16247, South Korea

  • Site 43

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Site 44

    RECRUITING

    Toronto, M5G 2M9, Canada

  • Site 45

    RECRUITING

    Seoul, 05505, South Korea

  • Site 46

    RECRUITING

    Viedma, R8500ACE, Argentina

  • Site 47

    WITHDRAWN

    Gyeonggi-do, 13496, South Korea

  • Site 48

    WITHDRAWN

    Orlando, Florida, 32804, United States

  • Site 49

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Site 5

    RECRUITING

    Jerusalem, 9112001, Israel

  • Site 50

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Site 51

    RECRUITING

    Hwasun, 58128, South Korea

  • Site 52

    RECRUITING

    Taichung, 40447, Taiwan

  • Site 53

    RECRUITING

    Brussels, 1200, Belgium

  • Site 54

    RECRUITING

    Rouen, 76038, France

  • Site 55

    RECRUITING

    Montpellier, 34298, France

  • Site 56

    RECRUITING

    Bordeaux, 33075, France

  • Site 57

    RECRUITING

    Marseille, 13005, France

  • Site 58

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Site 59

    RECRUITING

    Toulouse, 31100, France

  • Site 6

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • Site 60

    RECRUITING

    Greifswald, 17475, Germany

  • Site 61

    RECRUITING

    Pamplona, 31008, Spain

  • Site 62

    RECRUITING

    Pamplona, 31008, Spain

  • Site 63

    RECRUITING

    Namur, 5000, Belgium

  • Site 64

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Site 65

    RECRUITING

    Ratchathewi, Bangkok, 10400, Thailand

  • Site 66

    RECRUITING

    Nice, 06189, France

  • Site 67

    RECRUITING

    Madrid, 28041, Spain

  • Site 68

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Site 69

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Site 7

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Site 70

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Site 71

    RECRUITING

    Leuven, 3000, Belgium

  • Site 72

    RECRUITING

    Lyon, 69378, France

  • Site 73

    RECRUITING

    Marbella, 29660, Spain

  • Site 74

    RECRUITING

    Valencia, 46009, Spain

  • Site 75

    RECRUITING

    Madrid, 28040, Spain

  • Site 76

    RECRUITING

    Rosario, S2000KZE, Argentina

  • Site 77

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Site 78

    RECRUITING

    Tübingen, 72076, Germany

  • Site 79

    RECRUITING

    Lille, 59000, France

  • Site 8

    RECRUITING

    Orlando, Florida, 32827, United States

  • Site 80

    RECRUITING

    Barcelona, 08035, Spain

  • Site 81

    RECRUITING

    Milan, 20141, Italy

  • Site 82

    RECRUITING

    Hamburg, 20251, Germany

  • Site 83

    RECRUITING

    Northwood, HA62RN, United Kingdom

  • Site 84

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Site 85

    RECRUITING

    Rozzano, 20089, Italy

  • Site 86

    RECRUITING

    Ancona, 60126, Italy

  • Site 87

    RECRUITING

    Poitiers, 86021, France

  • Site 88

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Site 89

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Site 9

    RECRUITING

    Haifa, 3109601, Israel

  • Site 90

    RECRUITING

    London, SE19RT, United Kingdom

  • Site 91

    RECRUITING

    Hamburg, 22763, Germany

  • Site 92

    RECRUITING

    Panórama, 55236, Greece

  • Site 93

    RECRUITING

    Naples, 80131, Italy

  • Site 94

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Site 95

    RECRUITING

    Chaïdári, 12462, Greece

  • Site 96

    RECRUITING

    CABA, C1118AAT, Argentina

  • Site 97

    RECRUITING

    Brescia, 25123, Italy

  • Site 98

    RECRUITING

    Edegem, 2650, Belgium

  • Site 99

    RECRUITING

    Ghent, 9000, Belgium

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