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A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

500 patients around the world

Available in United States, Brazil

Janssen Research & Development, LLC

4Research sites

500Patients around the world

This study is for people with

Head and neck cancer

Squamous cell carcinoma of the head and neck

From 18 Years

All Gender

: Be more than or equal to 18 years of age or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater.
Have histologically or cytologically confirmed recurrent/metastatic HNSCC that is considered incurable by local therapies.
Eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx.
Must not have a primary tumor site of nasopharynx or primary tumor of unknown location.
Must have documented local testing results per local regulations.
Human papillomavirus status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization.
Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative.
Be treatment-naive for systemic therapy in the R/M setting.
Have an ECOG performance status of 0 or 1.
Have measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1.

: Have an uncontrolled illness.
Have untreated brain metastases or history of known presence of leptomeningeal disease.
Have a history of clinically significant cardiovascular disease.
Inadequate organ or bone marrow function.
Known allergies, hypersensitivity, contraindications, or intolerance to excipients of Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase.

Hospital Amaral Carvalho

Recruiting

R. Doná Silvéria, 150 - Chácara Braz Miraglia, Jaú - SP, 17210-080, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Recruiting

Rua Professor Annes Dias - Centro Histórico, Porto Alegre - RS, 90020-090, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

Recruiting

Av. Brg. Faria Lima, 5544 Sao Jose do Rio Preto - Estado de São Paulo 15090-000

Hospital Santa Rita

Recruiting

Av. Mal. Campos, 1579 - Nazareth, Vitória - ES, 29043-260, Brazil

StudyOrigAMI-5

SponsorJanssen Research & Development, LLC

Study typeInterventional

Conditions

Squamous cell carcinoma of the head and neck

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07276399