RecruitingPhase 3NCT06496178

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

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

Sponsor

Merus B.V.

Enrollment

500 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 trial is comparing a new targeted therapy drug called petosemtamab with standard single-agent chemotherapy (investigator's choice) in people with head and neck squamous cell carcinoma that has progressed after prior immunotherapy and platinum chemotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, or larynx) that has spread and cannot be cured with standard treatment - Your cancer has progressed after receiving both anti-PD-1 immunotherapy and platinum-based chemotherapy - You have at least one measurable tumor lesion - Your physical condition is adequate for treatment **You may NOT be eligible if...** - You have not received prior immunotherapy and platinum chemotherapy - You have active brain metastases - You have serious autoimmune conditions or active infections - You are pregnant or breastfeeding 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

DRUGInvestigator's Choice

Cetuximab

DRUGInvestigator's Choice

Methotrexate

DRUGInvestigator's Choice

Docetaxel

Locations(208)

Site 160

Mobile, Alabama, United States

Site 102

Prescott, Arizona, United States

Site 125

Scottsdale, Arizona, United States

Site 82

Duarte, California, United States

Site 25

La Jolla, California, United States

Site 173

Orange, California, United States

Site 28

Palo Alto, California, United States

Site 127

Sacramento, California, United States

Site 46

San Francisco, California, United States

Site 130

Lone Tree, Colorado, United States

Site 104

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

Site 12

Fort Myers, Florida, United States

Site 123

Jacksonville, Florida, United States

Site 9

Orlando, Florida, United States

Site 138

Tampa, Florida, United States

Site 187

Atlanta, Georgia, United States

Site 207

Atlanta, Georgia, United States

Site 152

Chicago, Illinois, United States

Site 68

Chicago, Illinois, United States

Site 31

Indianapolis, Indiana, United States

Site 8

Louisville, Kentucky, United States

Site 40

Baton Rouge, Louisiana, United States

Site 100

New Orleans, Louisiana, United States

Site 153

Columbia, Maryland, United States

Site 77

Boston, Massachusetts, United States

Site 103

Ann Arbor, Michigan, United States

Site 5

Detroit, Michigan, United States

Site 49

Maple Grove, Minnesota, United States

Site 124

Rochester, Minnesota, United States

Site 18

St Louis, Missouri, United States

Site 86

Hackensack, New Jersey, United States

Site 15

Albuquerque, New Mexico, United States

Site 24

New York, New York, United States

Site 98

Chapel Hill, North Carolina, United States

Site 122

Durham, North Carolina, United States

Site 23

Cincinnati, Ohio, United States

Site 87

Cleveland, Ohio, United States

Site 32

Columbus, Ohio, United States

Site 26

Portland, Oregon, United States

Site 151

Bensalem, Pennsylvania, United States

Site 158

Philadelphia, Pennsylvania, United States

Site 159

Philadelphia, Pennsylvania, United States

Site 50

Charleston, South Carolina, United States

Site 60

Chattanooga, Tennessee, United States

Site 54

Memphis, Tennessee, United States

Site 59

Nashville, Tennessee, United States

Site 67

Nashville, Tennessee, United States

Site 55

Denison, Texas, United States

Site 34

El Paso, Texas, United States

Site 51

Houston, Texas, United States

Site 7

Houston, Texas, United States

Site 94

Pearland, Texas, United States

Site 4

Salt Lake City, Utah, United States

Site 10

Blacksburg, Virginia, United States

Site 22

Charlottesville, Virginia, United States

Site 156

Winchester, Virginia, United States

Site 163

Seattle, Washington, United States

Site 6

Spokane, Washington, United States

Site 37

Buenos Aires, Argentina

Site 80

Buenos Aires, Argentina

Site 58

Caba, Argentina

Site 193

CABA, Argentina

Site 45

Córdoba, Argentina

Site 110

Rosario, Argentina

Site 57

Viedma, Argentina

Site 3

Darlinghurst, Australia

Site 170

Herston, Australia

Site 38

Melbourne, Australia

Site 30

Nedlands, Australia

Site 11

Saint Leonards, Australia

Site 73

Sydney, Australia

Site 129

Brussels, Belgium

Site 56

Brussels, Belgium

Site 92

Ghent, Belgium

Site 72

Leuven, Belgium

Site 108

Liège, Belgium

Site 69

Namur, Belgium

Site 154

Brasília, Brazil

Site 145

Porto Alegre, Brazil

Site 150

Porto Alegre, Brazil

Site 146

Recife, Brazil

Site 155

Rio de Janeiro, Brazil

Site 148

Rio de Janeiro, Brazil

Site 147

São Paulo, Brazil

Site 144

São Paulo, Brazil

Site 172

Montreal, Canada

Site 196

Toronto, Canada

Site 16

Providencia, Chile

Site 20

Recoleta, Chile

Site 27

Santiago, Chile

Site 21

Santiago, Chile

Site 188

Nový Jičín, Czechia

Site 201

Olomouc, Czechia

Site 202

Prague, Czechia

Site 105

Bordeaux, France

Site 162

Le Mans, France

Site 149

Lille, France

Site 118

Lyon, France

Site 115

Marseille, France

Site 106

Montpellier, France

Site 169

Nice, France

Site 114

Paris, France

Site 167

Paris, France

Site 136

Poitiers, France

Site 141

Rennes, France

Site 107

Rouen, France

Site 119

Toulouse, France

Site 142

Vandœuvre-lès-Nancy, France

Site 113

Villejuif, France

Site 101

Aachen, Germany

Site 121

Berlin, Germany

Site 165

Essen, Germany

Site 84

Giessen, Germany

Site 62

Greifswald, Germany

Site 79

Hamburg, Germany

Site 88

Hamburg, Germany

Site 112

Hanover, Germany

Site 116

Leipzig, Germany

Site 175

Mannheim, Germany

Site 168

München, Germany

Site 99

Würzburg, Germany

Site 91

Athens, Greece

Site 96

Athens, Greece

Site 120

Heraklion, Greece

Site 126

Rio, Greece

Site 83

Thessaloniki, Greece

Site 204

Nyíregyháza, Hungary

Site 195

Pécs, Hungary

Site 198

Szeged, Hungary

Site 19

Haifa, Israel

Site 1

Jerusalem, Israel

Site 14

Ramat Gan, Israel

Site 2

Tel Aviv, Israel

Site 93

Brescia, Italy

Site 111

Cuneo, Italy

Site 128

Milan, Italy

Site 81

Milan, Italy

Site 89

Naples, Italy

Site 203

Roma, Italy

Site 85

Rozzano, Italy

Site 132

Chūōku, Japan

Site 199

Fukuoka, Japan

Site 192

Fukuoka, Japan

Site 131

Kashiwa, Japan

Site 135

Miki, Japan

Site 205

Minatoku, Japan

Site 139

Nagoya, Japan

Site 186

Natori, Japan

Site 133

Ōsaka-sayama, Japan

Site 134

Sendai, Japan

Site 180

Kaunas, Lithuania

Site 181

Vilnius, Lithuania

Site 76

Amsterdam, Netherlands

Site 61

Nijmegen, Netherlands

Site 66

Utrecht, Netherlands

Site 190

Bydgoszcz, Poland

Site 143

Gdansk, Poland

Site 97

Gliwice, Poland

Site 177

Krakow, Poland

Site 200

Lodz, Poland

Site 117

Poznan, Poland

Site 179

Warsaw, Poland

Site 182

Coimbra, Portugal

Site 183

Lisbon, Portugal

Site 197

Portimão, Portugal

Site 185

Porto, Portugal

Site 161

Busan, South Korea

Site 13

Goyang-si, South Korea

Site 29

Hwasun, South Korea

Site 206

Seongnam-si, South Korea

Site 137

Seoul, South Korea

Site 36

Seoul, South Korea

Site 47

Seoul, South Korea

Site 208

Seoul, South Korea

Site 33

Soeul, South Korea

Site 164

Suwon, South Korea

Site 78

Barcelona, Spain

Site 109

Madrid, Spain

Site 75

Madrid, Spain

Site 71

Madrid, Spain

Site 166

Madrid, Spain

Site 63

Pamplona, Spain

Site 64

Pamplona, Spain

Site 74

Valencia, Spain

Site 184

Bellinzona, Switzerland

Site 189

Geneva, Switzerland

Site 194

Lausanne, Switzerland

Site 178

Sankt Gallen, Switzerland

Site 41

Changhua, Taiwan

Site 17

Kaohsiung City, Taiwan

Site 95

Kaohsiung City, Taiwan

Site 53

Taichung, Taiwan

Site 176

Tainan, Taiwan

Site 39

Taipei, Taiwan

Site 35

Taipei, Taiwan

Site 52

Taoyuan City, Taiwan

Site 65

Cambridge, United Kingdom

Site 174

Cardiff, United Kingdom

Site 171

Glasgow, United Kingdom

Site 44

Liverpool, United Kingdom

Site 157

London, United Kingdom

Site 140

London, United Kingdom

Site 90

London, United Kingdom

Site 42

London, United Kingdom

Site 48

Manchester, United Kingdom

Site 70

Middlesex, United Kingdom

Site 191

Newcastle upon Tyne, United Kingdom

Site 43

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06496178

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