RecruitingPhase 1Phase 2NCT06385080

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma

Sponsor

Janssen Research & Development, LLC

Enrollment

287 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

Summary

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the drug amivantamab — alone and in combination with other treatments — for people with head and neck squamous cell carcinoma (HNSCC), including both recurrent/metastatic and locally advanced forms of this cancer. **You may be eligible if...** - You have confirmed head and neck squamous cell cancer (of the throat, mouth, voice box, or similar area) - You are in generally good health (ECOG performance status 0–1) - Depending on the study cohort: your cancer may need to be HPV-positive, HPV-negative, or have specific PD-L1 test results - You have at least one measurable or evaluable tumor **You may NOT be eligible if...** - You have untreated brain metastases - You have had recent chemotherapy, targeted therapy, or immunotherapy (within 2–4 weeks) - You have a significant history of cardiovascular disease - You have uncontrolled interstitial lung disease or lung inflammation 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

BIOLOGICALAmivantamab

Amivantamab will be administered subcutaneously.

BIOLOGICALPembrolizumab

Pembrolizumab will be administered intravenously.

DRUGPaclitaxel

Paclitaxel will be administered intravenously.

DRUGCarboplatin

Carboplatin will be administered intravenously.

Locations(55)

University of California at San Diego Moores Cancer Center

La Jolla, California, United States

University of Colorado Denver Anschultz Medical Campus

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Beijing Cancer Hospital of Peking University

Beijing, China

West China School of Medicine/West China Hospital, Sichuan University

Cheng Du Shi, China

Linyi Cancer Hospital

Linyi, China

Fudan Cancer Hospital

Shanghai, China

Shanghai East Hospital

Shanghai, China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Institut Sainte Catherine

Avignon, France

Centre Oscar Lambret

Lille, France

CHU Nantes

Nantes, France

Institut Curie

Paris, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Klinikum der Landeshauptstadt Stuttgart

Stuttgart, Germany

Aichi Cancer Center

Nagoya, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach

Gliwice, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hosp Univ Vall D Hebron

Barcelona, Spain

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Addenbrooke's Hospital

Cambridge, United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, United Kingdom

Royal Marsden Hospital (Sutton)

London, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Imperial College London and Imperial College Healthcare NHS Trust

London, United Kingdom

University College London Hospitals

London, United Kingdom

The Christie Nhs Foundation Trust

Manchester, United Kingdom

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NCT06385080

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