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Recruiting Phase 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

Phase 3 – large-scale trial before approval
Conditions: Squamous Cell Carcinoma of Head and Neck

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 19
Australia (1)
Monash Medical Centre
Clayton
Belgium (1)
UZ Antwerpen
Edegem
Brazil (1)
Fundacao Doutor Amaral Carvalho
Jaú
China (1)
Tongren Hospital Outpatient Bldg
Beijing
Czech Republic (1)
Fakultni nemocnice Hradec Kralove
Hradec Králové
France (1)
Institut Sainte Catherine
Avignon
Germany (1)
Universitaetsklinikum Giessen und Marburg GmbH
Giessen
Hungary (1)
Debreceni Egyetem Klinikai Kozpont
Debrecen
India (1)
Apollo Speciality Hospital, Chennai
Chennai
Italy (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Japan (1)
Kansai Medical University Hospital
Hirakata
Mexico (1)
CO de Chihuahua
Chihuahua City
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Romania (1)
Spitalul Clinic Coltea
Bucharest
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
Hosp Univ Vall D Hebron
Barcelona
Taiwan (1)
Changhua Christian Hospital
Changhua
United Kingdom (1)
Addenbrooke's Hospital
Cambridge
United States (1)
Ironwood Cancer and Research Center
Chandler , Arizona
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.12.2025
Completion date
18.06.2029
Registry ID
NCT07276399
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.