|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | CureVac GmbH |
|---|---|
| Information provided by: | CureVac GmbH |
| ClinicalTrials.gov Identifier: | NCT00923312 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Biological: CV9201 |
Phase I Phase II |
| Study Type: | Interventional |
| 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) |
| Estimated Enrollment: | 33 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CV9201
CV9201 is composed of five formulated mRNAs (drug product components) encoding antigens that are overexpressed or exclusively expressed in NSCLC cells.
|
Biological: CV9201
CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.
|
Medical Need:
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.
Potential Benefits:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented stable disease or objective response according to RECIST criteria after initial chemotherapy or chemo-radiotherapy for advanced, unresectable disease:
Adequate organ function:
Exclusion Criteria:
Contacts and Locations| Germany | |
| RWTH Aachen | |
| 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 | |
| Nordwest Krankenhaus | |
| Frankfurt, Germany, 60488 | |
| Krankenhaus Großhansdorf | |
| 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 | |
| Switzerland | |
| UniversitätsSpital Basel | |
| Basel, Switzerland, 4031 | |
| UniversitätsSpital Zürich | |
| Zürich, Switzerland, 8091 | |
| Principal Investigator: | Alexander Knuth, Prof. Dr. | UniversitätsSpital Zürich |
More Information
| Responsible Party: | Karl-Josef Kallen, MD, PhD: Chief Medical Officer, CureVac GmbH |
| ClinicalTrials.gov Identifier: | NCT00923312 History of Changes |
| Other Study ID Numbers: | CV-9201-003 |
| Study First Received: | June 16, 2009 |
| Last Updated: | March 4, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |