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RECRUITING

NCT06525220

PHASE3

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

Sponsor: Merus B.V.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-09-25

Completion Date

2030-07

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Petosemtamab

MCLA-158

DRUG

Pembrolizumab

Humanized Antibody

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% or ≥ institutional normal limit, whichever is higher, 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.

Locations (191)

Site 164

Mobile, Alabama, United States

Site 36

La Jolla, California, United States

Site 27

Los Angeles, California, United States

Site 16

Palo Alto, California, United States

Site 19

Newark, Delaware, United States

Site 108

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

Site 14

Fort Myers, Florida, United States

Site 48

Orlando, Florida, United States

Site 8

Orlando, Florida, United States

Site 21

St. Petersburg, Florida, United States

Site 20

West Palm Beach, Florida, United States

Site 171

Atlanta, Georgia, United States

Site 50

Chicago, Illinois, United States

Site 2

Louisville, Kentucky, United States

Site 162

Baton Rouge, Louisiana, United States

Site 155

Minneapolis, Minnesota, United States

Site 168

St Louis, Missouri, United States

Site 94

Hackensack, New Jersey, United States

Site 6

Albuquerque, New Mexico, United States

Site 113

Durham, North Carolina, United States

Site 118

Winston-Salem, North Carolina, United States

Site 191

Cleveland, Ohio, United States

Site 43

Philadelphia, Pennsylvania, United States

Site 153

Philadelphia, Pennsylvania, United States

Site 154

Philadelphia, Pennsylvania, United States

Site 89

Chattanooga, Tennessee, United States

Site 115

Memphis, Tennessee, United States

Site 88

Nashville, Tennessee, United States

Site 22

Austin, Texas, United States

Site 1

Houston, Texas, United States

Site 18

Plano, Texas, United States

Site 17

Sugarland, Texas, United States

Site 15

Tyler, Texas, United States

Site 10

Salt Lake City, Utah, United States

Site 12

Blacksburg, Virginia, United States

Site 23

Norfolk, Virginia, United States

Site 170

CABA, Argentina

Site 96

CABA, Argentina

Site 37

CABA, Argentina

Site 31

Córdoba, Argentina

Site 30

La Rioja, Argentina

Site 76

Rosario, Argentina

Site 46

Viedma, Argentina

Site 11

Blacktown, New South Wales, Australia

Site 24

St Leonards, New South Wales, Australia

Site 166

Greenslopes, Queensland, Australia

Site 151

Melbourne, Victoria, Australia

Site 53

Brussels, Belgium

Site 98

Edegem, Belgium

Site 99

Ghent, Belgium

Site 71

Leuven, Belgium

Site 109

Liège, Belgium

Site 63

Namur, Belgium

Site 149

Rio de Janeiro, Rio de Janeiro, Brazil

Site 141

Belo Horizonte, Brazil

Site 144

Natal, Brazil

Site 140

Porto Alegre, Brazil

Site 142

Porto Alegre, Brazil

Site 137

Recife, Brazil

Site 138

Rio de Janeiro, Brazil

Site 134

São Paulo, Brazil

Site 136

São Paulo, Brazil

Site 165

St. John's, Canada

Site 44

Toronto, Canada

Site 111

Winnipeg, Canada

Site 38

Antofagasta, Chile

Site 26

Providencia, Chile

Site 29

Recoleta, Chile

Site 40

Santiago, Chile

Site 32

Santiago, Chile

Site 34

Santiago, Chile

Site 25

Temuco, Chile

Site 56

Bordeaux, France

Site 101

Le Mans, France

Site 79

Lille, France

Site 72

Lyon, France

Site 57

Marseille, France

Site 55

Montpellier, France

Site 66

Nice, France

Site 105

Paris, France

Site 143

Paris, France

Site 87

Poitiers, France

Site 54

Rouen, France

Site 59

Toulouse, France

Site 64

Vandœuvre-lès-Nancy, France

Site 112

Villejuif, France

Site 133

Bonn, Germany

Site 178

Dortmund, Germany

Site 100

Dresden, Germany

Site 60

Greifswald, Germany

Site 82

Hamburg, Germany

Site 91

Hamburg, Germany

Site 104

Hanover, Germany

Site 129

Mannheim, Germany

Site 148

München, Germany

Site 121

Münster, Germany

Site 78

Tübingen, Germany

Site 130

Ulm, Germany

Site 110

Würzburg, Germany

Site 119

Pátrai, Achaia, Greece

Site 156

Athens, Attica, Greece

Site 117

Heraklion, Crete, Greece

Site 95

Chaïdári, Greece

Site 92

Panórama, Greece

Site 189

Pécs, Hungary

Site 187

Szeged, Hungary

Site 9

Haifa, Israel

Site 5

Jerusalem, Israel

Site 3

Ramat Gan, Israel

Site 7

Tel Aviv, Israel

Site 86

Ancona, Italy

Site 97

Brescia, Italy

Site 180

Cagliari, Italy

Site 139

Meldola, Italy

Site 122

Milan, Italy

Site 81

Milan, Italy

Site 152

Naples, Italy

Site 93

Naples, Italy

Site 186

Rome, Italy

Site 85

Rozzano, Italy

Site 167

Nagoya, Aichi-ken, Japan

Site 123

Kashiwa, Chiba, Japan

Site 185

Fukuoka, Fukuoka, Japan

Site 127

Hiragi, Kagawa-ken, Japan

Site 174

Natori-shi, Miyagi, Japan

Site 126

Sendai, Miyagi, Japan

Site 125

Ōsaka-sayama, Osaka, Japan

Site 124

Chuo Ku, Tokyo, Japan

Site 188

Minato-Ku, Tokyo, Japan

Site 183

Kaunas, Lithuania

Site 179

Vilnius, Lithuania

Site 163

Johor Bahru, Malaysia

Site 159

Kuching, Malaysia

Site 161

Putrajaya, Malaysia

Site 84

Amsterdam, Netherlands

Site 58

Nijmegen, Netherlands

Site 68

Utrecht, Netherlands

Site 150

Bydgoszcz, Poland

Site 131

Gdansk, Poland

Site 106

Gliwice, Poland

Site 116

Krakow, Poland

Site 190

Lodz, Poland

Site 158

Warsaw, Poland

Site 172

Coimbra, Portugal

Site 182

Lisbon, Portugal

Site 181

Portimão, Portugal

Site 175

Porto, Portugal

Site 145

Busan, South Korea

Site 13

Goyang-si, South Korea

Site 47

Gyeonggi-do, South Korea

Site 51

Hwasun, South Korea

Site 28

Seoul, South Korea

Site 35

Seoul, South Korea

Site 45

Seoul, South Korea

Site 42

Suwon, South Korea

Site 157

Suwon, South Korea

Site 120

Badalona, Spain

Site 80

Barcelona, Spain

Site 128

Madrid, Spain

Site 75

Madrid, Spain

Site 67

Madrid, Spain

Site 160

Madrid, Spain

Site 73

Marbella, Spain

Site 61

Pamplona, Spain

Site 62

Pamplona, Spain

Site 74

Valencia, Spain

Site 41

Changhua, Taiwan

Site 4

Kaohsiung City, Taiwan

Site 103

Kaohsiung City, Taiwan

Site 52

Taichung, Taiwan

Site 39

Taipei, Taiwan

Site 33

Taipei, Taiwan

Site 49

Taoyuan, Taiwan

Site 114

Bangkok Noi, Bangkok, Thailand

Site 107

Pathum Wan, Bangkok, Thailand

Site 65

Ratchathewi, Bangkok, Thailand

Site 146

Chiang Rai, Changwat Chiang Rai, Thailand

Site 77

Hat Yai, Changwat Songkhla, Thailand

Site 184

Ankara, Turkey (Türkiye)

Site 176

Antalya, Turkey (Türkiye)

Site 102

Cambridge, United Kingdom

Site 169

Cardiff, United Kingdom

Site 132

London, United Kingdom

Site 90

London, United Kingdom

Site 69

London, United Kingdom

Site 173

Manchester, United Kingdom

Site 177

Newcastle upon Tyne, United Kingdom

Site 83

Northwood, United Kingdom

Site 147

Southampton, United Kingdom

Site 70

Sutton, United Kingdom

Site 135

Taunton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (191)