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ACTIVE NOT RECRUITING

NCT06496178

PHASE3

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)

Sponsor: Genmab

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

621

Start Date

2024-06-25

Completion Date

2029-03

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Petosemtamab

MCLA-158

DRUG

Investigator's Choice

Cetuximab

DRUG

Investigator's Choice

Methotrexate

DRUG

Investigator's Choice

Docetaxel

Inclusion Criteria: * 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. * 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) Exclusion Criteria: * 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. * 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

Locations (193)

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 152

Chicago, Illinois, United States

Site 213

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 214

The Bronx, 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 218

Cleveland, 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 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 216

Madison, Wisconsin, United States

Site 58

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 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 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 201

Olomouc, Czechia

Site 105

Bordeaux, France

Site 211

Brest, 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

And 93 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (193)