Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
décembre 2025
juin 2029
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 24/04/2026 09:30:07 | Contacter | ||
Critères
Tous
- 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