Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an out-patient setting, in patients with stage IIIB/IV NSCLC.
The phase I part of the study consists of a dose escalation phase, in which the recommended dose (RD) for the phase IIa part of the study will be established based on the incidence of dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will be included at the RD, to confirm the safety and explore the activity of that dose.
This study will take place in Switzerland (2 sites) and Germany (11 sites).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Phase I/IIa Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)|
- Phase I: Determination of the recommended dose (RD) for exploration in the phase IIa part of the study [ Time Frame: During the first 2-3 month of Phase I ] [ Designated as safety issue: Yes ]
- Phase II: Assessment of safety and tolerability of the treatment regimen [ Time Frame: Complete duration of Phase II ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||February 2014|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
CV9201 is composed of five formulated mRNAs (drug product components) encoding antigens that are overexpressed or exclusively expressed in NSCLC cells.
CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.
Lung cancer is the leading cause of cancer mortality in developed countries; about 87% of lung cancers are of the NSCLC type. Patients with more advanced but non-metastatic disease (IIIA or IIIB) usually undergo chemotherapy and/or radiation therapy, with or without secondary surgical resection. Patients with progression after chemotherapy and/or radiotherapy may receive second-line treatment with targeted therapies. Despite these aggressive treatments, only about 5% of patients with metastatic disease survive for 5 or more years. Given these dismal statistics, it is clear that new therapeutic approaches for treatment of NSCLC are urgently needed.
CV9201 is an mRNA-based vaccine for the treatment of human NSCLC that is based on CureVac's RNActive® technology.
As an mRNA-based vaccine, CV9201 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome.
For the planned first-in-man study, CV9201 will be administered in 5 doses. The phase I part of this phase I/IIa study is a dose finding study, to determine the RD for the phase IIa part.
|Aachen, Germany, 52074|
|Medizinische Klinik III, Universitätsklinikum Bonn|
|Bonn, Germany, 53111|
|Medizinische Klinik V, Klinikum Darmstadt|
|Darmstadt, Germany, 64283|
|Medizinische Klinik I, Universitätsklinikum Dresden|
|Dresden, Germany, 01304|
|Frankfurt, Germany, 60488|
|Großhansdorf, Germany, 22927|
|Universitätsklinikum Hamburg Eppendorf, Medizinische Klinik II|
|Hamburg, Germany, 20246|
|Thoraxklinik am Universitätsklinikum Heidelberg|
|Heidelberg, Germany, 69126|
|Universitätsklinikum des Saarlandes|
|Homburg, Germany, 66421|
|III. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz|
|Mainz, Germany, 55131|
|III. Medizinische Klinik, Klinikum rechts der Isar|
|München, Germany, 81675|
|Medizinische Klinik II, Universität Tübingen|
|Tübingen, Germany, 72074|
|Basel, Switzerland, 4031|
|Zürich, Switzerland, 8091|
|Principal Investigator:||Alexander Knuth, Prof. Dr.||UniversitätsSpital Zürich|