ABP 206 Biosimilar

A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.

Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.
The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13 months.

Klinische Settings

Indikation: Malignes Melanom

Therapiesituation: adjuvant

Einschlusskriterien

  • At least 18 years of age
  • Completely removed melanoma by surgery performed within 12 weeks of randomization
  • Advanced Melanoma
  • Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Ausschlusskriterien

  • Previous anti-cancer treatment
  • Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
  • Ocular or uveal melanoma or history of carcinomatosis meningitis
  • History of auto-immune disease
  • Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product

Links

An der Studie beteiligte Zentren

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

Frankfurt am Main

Zentrum

Hautkrebszentrum Frankfurt am Main
Klinik für Dermatologie, Venerologie und Allergologie; Universitätsklinikum Frankfurt
Theodor-Stern-Kai 7, Haus 28 60590 Frankfurt am Main Deutschland

www.unimedizin-ffm.de

Kontakt

Herr Dr. Johannes Kleemann Hautkrebszentrum@unimedizin-ffm.de

Gera

Zentrum

Hauttumorzentrum Gera
SRH Wald-Klinikum Gera
Straße des Friedens 122 07548 Gera Deutschland

www.waldklinikumgera.de

Kontakt

Beatrice Schell ines.kaufmann@srh.de

Köln

Zentrum

Hauttumorzentrum im CIO Köln
Centrum für Integrierte Onkologie Aachen Bonn Köln Düsseldorf im Universitätsklinikum Köln
Kerpener Straße 62 50937 Köln Deutschland

dermatologie.uk-koeln.de

Kontakt

Frau PD Dr. Cindy Franklin hauttumorzentrum@uk-koeln.de