DUNCAN - PH-L19IL2TNFNMSC-04/19

A Phase II Study of Intratumoral Administration of L19IL2/L19TNF in Non-melanoma Skin Cancer Patients With Presence of Injectable Lesions

This clinical phase II study is designed to investigate the efficacy of intratumorally administered L19IL2/L19TNF in patients with injectable lesions of BCC or cSCC. Favorable tumor responses following intralesional treatment with L19IL2/L19TNF have been observed in patients with injectable melanoma lesions of stage III or IV, for injected and non-injected lesions.

The proposed clinical phase II study plans to investigate the intralesional administration of 6.5 Mio IU of L19IL2 (~1.08 mg) and 200 µg of L19TNF to be administered in an approximate volume of 1.0 mL as a single or multiple intratumoral injections in patients with high-risk BCC or cSCC.

There is a high medical need for non-invasive therapeutic strategies with a comparable good response rate and high recurrence free survival for treatment of patients with BCC or cSCC, who cannot be treated by or refuse surgery. Surgery is not always applicable, as it may not be feasible due to the anatomic location, may have a poor cosmetic outcome for the patient or is generally not accepted as treatment strategy by the patient. However, current non-surgical treatment strategies have a considerably reduced response rate and recurrence free survival. Based on the favorable results for injected and non-injected lesions obtained in the phase II study of L19IL2/L19TNF and the good safety profile seen in the subsequent phase III study, both in stage III or IV melanoma patients, we believe, that patients with BCC or cSCC will profit from intralesional treatment with L19IL2/L19TNF.

Klinische Settings

Indikation: Plattenepithelkarzinom

Einschlusskriterien

  • High-risk, localized (non-metastatic, node negative, single or multifocal) BCC or cSCC amenable to intratumoral injection.
  • Patients with injectable and measurable regional cutaneous or subcutaneous in-transit or satellite metastasis but without regional nodal involvement are also eligible.
  • ECOG 0-1
  • Patients may have previously received topical or systemic chemotherapy, immunotherapy or radiation therapy on the tumor sites.

Ausschlusskriterien

  • Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study
  • Patients with node positive BCC/cSCC who are candidate to SHH inhibitor or checkpoint inhibitor therapy.
  • History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiacarrhythmias and heart insufficiency (any grade

Links

An der Studie beteiligte Zentren

Augsburg

Zentrum

Hauttumorzentrum Universitätsklinikum Augsburg
Universitätsklinikum Augsburg - Medizincampus Süd
Sauerbruchstraße 6 86179 Augsburg Deutschland

www.uk-augsburg.de

Kontakt

Frau Prof. Dr. Julia Welzel dermatologie@uk-augsburg.de

Berlin

Zentrum

HautTumorCentrumCharité (HTCC) im Charité Comprehensive Cancer Center
Charité - Campus Mitte
Charitéplatz 1 10117 Berlin Deutschland

cccc.charite.de

Kontakt

Herr Prof. Dr. Thomas Eigentler thomas.eigentler@charite.de

Dresden

Zentrum

Hauttumorzentrum am Nationalen Centrum für Tumorerkrankungen Dresden (NCT/UCC)
Universitätsklinikum Carl Gustav Carus Dresden
Fetscherstraße 74 01307 Dresden Deutschland

www.uniklinikum-dresden.de

Kontakt

Frau Prof. Dr. Friedegund Meier Friedegund.Meier@uniklinikum-dresden.de

Essen

Zentrum

Hauttumorzentrum am Westdeutschen Tumorzentrum
Universitätsmedizin Essen
Hufelandstraße 55 45147 Essen Deutschland

hautklinik.uk-essen.de

Kontakt

Herr Prof. Dr. Dirk Schadendorf sekretariat.dermatologie@uk-essen.de

Heidelberg

Zentrum

Hauttumorzentrum der Universitäts-Hautklinik und des NCT Heidelberg Im Neuenheimer Feld 440/460 69120 Heidelberg Deutschland

www.klinikum.uni-heidelberg.de

Kontakt

Frau Prof. Dr. Jessica Hassel Hauttumorzentrum@med.uni-heidelberg.de

Kiel

Zentrum

Hautkrebszentrum Kiel
Klinik für Dermatologie, Venerologie und Allergologie
Universitätsklinikum Schleswig-Holstein Campus Kiel
Arnold-Heller-Straße 3 24105 Kiel Deutschland

www.uksh.de

Kontakt

Frau PD Dr. Katharina C. Kähler dermaambulanz@uksh.de

Regensburg

Zentrum

Hautkrebszentrum Ostbayern
Klinik und Poliklinik für Dermatologie
Universitätsklinikum Regensburg
Franz-Josef-Strauß-Allee 11 93053 Regensburg Deutschland

www.ukr.de

Kontakt

Herr Prof. Dr. Dr. Sebastian Haferkamp sekretariat.derma@ukr.de

Tübingen

Zentrum

Studienzentrum Onkologie
Zentrum für Dermatoonkologie Tübingen, Universitäts-Hautklinik
CCC Tübingen-Stuttgart am Universitätsklinikum Tübingen
Liebermeisterstr. 25 72076 Tübingen Deutschland

www.medizin.uni-tuebingen.de

Kontakt

Frau Dr. Teresa Amaral teresa.amaral@med.uni-tuebingen.de