last updated at 16.10.2019

NadiHN

Offene, randomisierte Phase-II-Studie bei Patienten mit resektablem fortgeschrittenem Plattenepithelcarcinom des Kopf-Hals-Bereichs, die die Wirksamkeit und Sicherheit von Nivolumab in Kombination mit einer adjuvanten Strahlentherapie versus der Wirksamke

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS
2016-004787-20 in preparation

Diagnose

  • Kopf-Hals-Karzinom

Studienziel / Fragestellung

Primäres Prüfziel
  • Ansprechrate

Sekundäre Prüfziele
  • Gesamtüberleben

    Sicherheit

    Lebensqualität

Patientenmerkmale

Stadium

intermediate risk

Alter

18-99

Ausschlusskriterien

Auswahl:

     

  1. Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx or salivary gland or non-squamous histologies (e.g. mucosal melanoma) are not allowed.
  2. Stage III, stage IVA with one of the following risk factors: extracapsular growth of the lymph nodes, perineural invasion or resection border < 5 mm (platinum chemotherapy recommended) or Stage IVB, IVC
  3. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  4. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  5. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  6.  

Einschlusskriterien

Auswahl:

     

  1. Histologically confirmed squamous cell carcinoma of the head and neck region (oral cavity, pharynx, larynx), stage III (T1-3N0-1M0), stage IVA (T1-3N2M0 and T4aN0-2M0) with curative intent (with completed first line treatment with surgery). No presence of the following risk factors: extracapsular growth of the lymph nodes, perineural invasion or resection border < 5 mm, in these cases a platinum chemotherapy is recommended).
  2. Chest x-ray (at a minimum) or chest CT scan (with or without contrast) within 8 weeks prior to enrollment.
  3. Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that ist subsequently suspersed by intraoperative negative margins. Similary patients whose tumors had focally positive margins in the main specimen but negative margins from reexcised samples in the region of the positve margin are eligible.
  4. Males and Females ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  5. Documentation of p16-positive or p16-negative disease to determine human papillomavirus (HPV) status of tumor for SCCHN of the oropharynx.
  6. Be free of signs of remaining cancer/in complete remission (CR) in a radiological and clinical evaluation prior to enrollment.
  7.  

Studiendesign

  • Multizentrisch
  • Open Label
  • Phase II
  • Prospektiv
  • Zweiarmig

Intervention

Nivolumab plus Radiotherapie vs alleinige Radiotherapie

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • Universität Bonn

Prüfzentrum 1

 

  • Klinik für Strahlentherapie und Radioonkologie

Studienbüro

  • Klinik für Strahlentherapie und Radioonkologie

Prüfer (Hauptprüfer im Zentrum)

Dr. Bálint Tamaskovics

Stellvertretender Prüfer

  • Univ.-Prof. Dr. med. Wilfried Budach
  • Dr. Jan Haussmann

Ärztliches Mitglied der Prüfgruppe

  • PD Dr.med. Christiane Matuschek
  • Prof. Dr. Stephan Gripp
  • Prof. Dr. E. Bölke
  • F. Djiepmo
  • Dr. Michael Rudoy

Studienkontakt im Prüfzentrum

  • Univ.-Prof. Dr. med. Wilfried Budach

Prüfzentrum 2

 

  • Universitätsklinik RWTH Aachen

Studienbüro

  • Klinik für Radioonkologie & Strahlentherapie

Prüfer (Hauptprüfer im Zentrum)

Univ.-Prof. Dr. med. Michael J. Eble

Stellvertretender Prüfer

  • Dr. Liane König

Ärztliches Mitglied der Prüfgruppe

  • Prof. Dr. M. Westhofen
  • Dr. Philip Bruners
  • Ludmilla Timm

Studienkontakt im Prüfzentrum

  • Univ.-Prof. Dr. med. Michael J. Eble
  • Tel. 0241/8089260

Prüfzentrum 3

 

  • Medizinische Klinik & Poliklinik III

Studienbüro

  • Medizinische Klinik & Poliklinik III

Prüfer (Hauptprüfer im Zentrum)

Univ.-Prof. Dr. med. Peter Brossart

Stellvertretender Prüfer

  • Dr. Matthias Zipfel
  • PD Dr. Georg Feldmann

Ärztliches Mitglied der Prüfgruppe

  • PD Dr. Georg Feldmann
  • Dr. Jai-Juen Shiue
  • Dr. Kirstin Klinz
  • Dr. Franz-Georg Bauernfeind

Studienkontakt im Prüfzentrum

  • Univ.-Prof. Dr. med. Peter Brossart
  • Dr. Kirstin Klinz

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