20210031
A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).
All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.
The total duration of study participation for each subject will be approximately 26 months.
Klinische Settings
Indikation: Malignes Melanom
Therapiesituation: inoperable fortgeschritten, Erstlinie
Einschlusskriterien
- At least 18 years of age.
- Histologically confirmed unresectable or metastatic melanoma.
- Subject has no prior systemic treatment for advanced disease.
- Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Ausschlusskriterien
- Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
- Subject has active central nervous system (CNS) metastases not previously treated.
- Ocular melanoma.
- Subject has active or known immune-mediated disorders.
- Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
- Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
Links
An der Studie beteiligte Zentren
Zentrum
Hautkrebszentrum Frankfurt am Main
Klinik für Dermatologie, Venerologie und Allergologie; Universitätsklinikum Frankfurt Theodor-Stern-Kai 7, Haus 28
60590 Frankfurt am Main
Deutschland
Kontakt
Herr Dr. Johannes Kleemann Hautkrebszentrum@unimedizin-ffm.de
Zentrum
Hauttumorzentrum im CIO Köln
Centrum für Integrierte Onkologie Aachen Bonn Köln Düsseldorf im Universitätsklinikum Köln Kerpener Straße 62
50937 Köln
Deutschland
Kontakt
Frau PD Dr. Cindy Franklin hauttumorzentrum@uk-koeln.de