RecruitingPhase 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 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

Sponsor

Merus B.V.

Enrollment

700 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This large phase 3 study is comparing two immunotherapy regimens for people with head and neck cancer that has returned or spread. One group receives pembrolizumab alone (an already-approved treatment); the other receives pembrolizumab combined with a new drug called petosemtamab. Researchers hope the combination will be more effective at slowing or stopping the cancer. **You may be eligible if...** - You are 18 or older - You have confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) that has spread or cannot be cured surgically - Your cancer expresses a protein called PD-L1 (CPS score of 1 or higher) - You have not had systemic (whole-body) treatment for this cancer in its recurrent or metastatic form - Your heart, organ function, and overall health meet the required levels **You may NOT be eligible if...** - You have untreated or symptomatic brain metastases - You have an active autoimmune disease requiring immunosuppressive treatment - You need ongoing immunosuppressant medications - You have had a solid organ or bone marrow transplant - Your cancer is in the nasopharynx or sinonasal area - You are pregnant or breastfeeding - You have significant heart problems including recent heart attack or severe heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPetosemtamab

MCLA-158

DRUGPembrolizumab

Humanized Antibody

Locations(197)

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 197

Chicago, Illinois, 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

Sugar Land, 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 141

Belo Horizonte, Brazil

Site 144

Natal, Brazil

Site 140

Porto Alegre, Brazil

Site 142

Porto Alegre, Brazil

Site 137

Recife, Brazil

Site 149

Rio de Janeiro, 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 195

Olomouc, Czechia

Site 192

Prague, Czechia

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 194

Nyíregyháza, Hungary

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 City, Taiwan

Site 114

Bangkok Noi, Bangkok, Thailand

Site 107

Pathum Wan, Bangkok, Thailand

Site 65

Ratchathewi, Bangkok, Thailand

Site 77

Hat Yai, Changwat Songkhla, Thailand

Site 146

Chiang Rai, Thailand

Site 196

Ankara, Turkey (Türkiye)

Site 184

Ankara, Turkey (Türkiye)

Site 176

Antalya, Turkey (Türkiye)

Site 193

Istanbul, 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

View Full Details on ClinicalTrials.gov

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NCT06525220

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