IVAC MUTANOME Phase I Clinical Trial
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||First-in-human Study Evaluating the Safety, Tolerability and Immunogenicity of i.n. Administration of a Personalized Vaccination With IVAC MUTANOME Vaccine w/o Initial Treatment With RBL001/RBL002 Vaccine in Patients With Advanced Melanoma|
- Safety and tolerability of repetitive doses [ Time Frame: up to a maximum of 189 days ]Number of Patients with adverse events, total number of adverse events
- Monitoring of vaccine-induced cellular immune response, [ Time Frame: 161 days ]Determination of pharmacodynamic activity
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||April 2017|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: IVAC MUTANOME RBL001/RBL002
All participants will be treated with the personalized IVAC MUTANOME vaccine with or without prior treatment with RBL001/RBL002 vaccine depending on expression of these two antigens. Vaccines will be administered intra-nodally.
Biological: IVAC MUTANOME, RBL001/RBL002
Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.
Other Name: cancer vaccine
IVAC MUTANOME is a poly-neo-epitopic coding RNA vaccine targeting the unique mutation signature of an individual patient. It is engineered on demand, provided as two patient-specific RNA drug products and administered as an individual treatment.
RBL001/RBL002 and IVAC MUTANOME are naked ribonucleic acid (RNA) based recombinant vaccines optimized to induce antigen-specific CD8+ and CD4+ T cell responses against melanoma associated target antigens.
The two antigens are well characterized antigens in melanoma that have been previously utilized with excellent safety and proven immunogenicity as vaccine targets in a number of independent clinical trials.
The overall rationale of the study is to determine safety of the novel RNA-based vaccine strategy and determine the number and function of vaccine-induced antigen-specific immune-responses as early biomarkers for the clinical mode of action.
The IVAC MUTANOME vaccine approach is based on targeting multiple immunogenic tumour mutations unique to a given patient's tumour using a poly-epitopic RNA-based vaccine manufactured for use in a single patient only. Parallel to the target discovery process and on demand manufacturing of IVAC MUTANOME vaccine patients with RBL001 and/ or RBL002 positive-tumours will receive the RBL001/RBL002 vaccine. Patients which tumours that are RBL001 and RBL002 negative can also be included into the clinical study but will not receive RBL001/RBL002 prior to IVAC MUTANOME. Applying this approach the RBL001/RBL002 vaccine and the IVAC MUTANOME vaccine administration is expected to lead to several effects contributing to their immunological (therapeutic) effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02035956
|Medizinische Universität Wien|
|Wien, AT-Wien, Austria, 1090|
|Hautklinik und Poliklinik Universitätsmedizin der Johannes-Gutenberg Universität Mainz|
|Mainz, Germany, 55131|
|Klinik für Dermatologie, Venerologie und Allergologie UMM - Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Ruprecht-Karls-Universität Heidelberg|
|Mannheim, Germany, 68167|
|Study Director:||Ugur Sahin, Prof. Dr.||Biontech RNA Pharmaceuticals GmbH|