Phase Ib study evaluating a self-adjuvanted mRNA cancer vaccine (RNActive) combined with local radiation as consolidation and maintenance treatment for patients with stage IV non-small cell lung cancer

  • Background: Advanced non-small cell lung cancer (NSCLC) represents a significant unmet medical need. Despite advances with targeted therapies in a small subset of patients, fewer than 20% of patients survive for more than two years after diagnosis. Cancer vaccines are a promising therapeutic approach that offers the potential for durable responses through the engagement of the patient's own immune system. CV9202 is a self-adjuvanting mRNA vaccine that targets six antigens commonly expressed in NSCLC (NY ESO-1, MAGEC1, MAGEC2, 5 T4, survivin, and MUC1). Methods/Design: The trial will assess the safety and tolerability of CV9202 vaccination combined with local radiation designed to enhance immune responses and will include patients with stage IV NSCLC and a response or stable disease after first-line chemotherapy or therapy with an EGFR tyrosine kinase inhibitor. Three histological and molecular subtypes of NSCLC will be investigated (squamous and non-squamous cell with/without EGFR mutations). All patients will receive two initial vaccinations with CV9202 prior to local radiotherapy (5 GY per day for four successive days) followed by further vaccinations until disease progression. The primary endpoint of the study is the number of patients experiencing Grade >3 treatment-related adverse events. Pharmacodynamic analyses include the assessment of immune responses to the antigens encoded by CV9202 and others not included in the panel (antigen spreading) and standard efficacy assessments. Discussion: RNActive self-adjuvanted mRNA vaccines offer the potential for simultaneously inducing immune responses to a wide panel of antigens commonly expressed in tumors. This trial will assess the feasibility of this approach in combination with local radiotherapy in NSCLC patients.

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Author:Martin Sebastian, Alexandros Papachristofilou, Christian Weiß, Martin Früh, Richard Cathomas, Wolfgang Hilbe, Thomas Wehler, Gerd Rippin, Sven D. Koch, Birgit Scheel, Mariola Fotin-Mleczek, Regina Heidenreich, Karl-Josef Kallen, Ulrike Gnad-Vogt, Alfred Zippelius
Pubmed Id:
Parent Title (English):BMC cancer
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Date of Publication (online):2014/10/06
Date of first Publication:2014/10/06
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2014/10/29
Tag:CV9202; RNActive; local radiotherapy; mRNA vaccine; non-small cell lung cancer
Page Number:10
Institutes:Biochemie, Chemie und Pharmazie / Biochemie und Chemie
Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 2.0