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

Behandlungszentren im CIO

Bonn


Ziele

Primäres Prüfziel

Gesamtüberleben

Objektives Ansprechen

Sekundäre Prüfziele für die Behandlungsarme:

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Design

Design

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Phase

III

Zentren

Multizentrisch

Datenerhebung

Prospektiv

Interventionsgruppen

Zweiarmig

Verblindung

Open-Label

Erkrankung

Diagnose

Kopf-Hals-Karzinom [C00-C14, C32]

Diagnosenbeschreibung

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Mutation

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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

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Substanz

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Zuständige Gesamtstudie

Sponsor

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Leiter der klinischen Prüfung (LKP)

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Studiengruppen/-zentrale

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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)