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Набира участници Фаза 3 NCT07276399

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Squamous Cell Carcinoma of Head and Neck

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.
Кой може да участва
Inclusion criteria: * 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 (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) 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 (ISH). 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 (RECIST) version (v).1.1 Exclusion criteria: * 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
Места на провеждане 19
Австралия (1)
Monash Medical Centre
Clayton
Белгия (1)
UZ Antwerpen
Edegem
Бразилия (1)
Fundacao Doutor Amaral Carvalho
Jaú
Китай (1)
Tongren Hospital Outpatient Bldg
Beijing
Чехия (1)
Fakultni nemocnice Hradec Kralove
Hradec Králové
Франция (1)
Institut Sainte Catherine
Avignon
Германия (1)
Universitaetsklinikum Giessen und Marburg GmbH
Giessen
Унгария (1)
Debreceni Egyetem Klinikai Kozpont
Debrecen
Индия (1)
Apollo Speciality Hospital, Chennai
Chennai
Италия (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Япония (1)
Kansai Medical University Hospital
Hirakata
Mexico (1)
CO de Chihuahua
Chihuahua City
Полша (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Румъния (1)
Spitalul Clinic Coltea
Bucharest
Южна Корея (1)
Seoul National University Hospital
Seoul
Испания (1)
Hosp Univ Vall D Hebron
Barcelona
Taiwan (1)
Changhua Christian Hospital
Changhua
Великобритания (1)
Addenbrooke's Hospital
Cambridge
САЩ (1)
Ironwood Cancer and Research Center
Chandler , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.12.2025
Крайна дата
18.06.2029
Регистрационен номер
NCT07276399
Източник
anzctr
Запитване за медицински туризъм

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