Letzte Aktualisierung: 06.05.2026
Kopf-Hals-Karzinom [C00-C14, C32]
OrigAMI-5
Aktive Studien
Studieninformationen
Randomisierte, multizentrische, Open-Label-Phase 3-Prüfung zu Amivantamab zusätzlich zu Carboplatin und Pembrolizumab im Vergleich zur Standardbehandlung mit Platin und Pembrolizumab und 5-FU bei Patienten mit therapienaivem rezidivierendem/metastasierendem Plattenepithelkarzinom der Kopf-Hals-Region
Ziele
Primäres Prüfziel
Gesamtüberleben
Objektives Ansprechen
Sekundäre Prüfziele für die Behandlungsarme:
—
Design
Design
—
Phase
III
Zentren
Multizentrisch
Datenerhebung
Prospektiv
Interventionsgruppen
Zweiarmig
Verblindung
Open-Label
Erkrankung
Diagnose
Kopf-Hals-Karzinom [C00-C14, C32]
Diagnosenbeschreibung
—
Mutation
—
Patienten
Alter
18 - 99 Jahre
Einschlusskriterien
- 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
Ausschlusskriterien
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
Therapie
Intervention
—
Substanz
—
| Prüfplancode | 61186372HNC3001 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT07276399 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
Sponsor
—
Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
—
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




