Spots Global Cancer Trial Database for An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer
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Trial Identification
Brief Title: An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer
Official Title: An Open Label Randomised Phase II Trial of RNActive® Cancer Vaccine (CV9104) in High Risk and Intermediate Risk Patients With Prostate Cancer
Study ID: NCT02140138
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the induction of immune responses against CV9104 administered by conventional intradermal injection or with a needle-free intradermal injection device and to assess the safety and tolerability of CV9104 administered by conventional intradermal injection versus injection with a needle-free intradermal injection device versus no injection.
Detailed Description: This study is the second clinical trial of the RNActive® vaccine. It is composed of 6 RNActive® drug product components, coding for 6 antigens that are overexpressed in PCA compared to healthy tissue. Each of the 6 prostate specific antigens that are encoded by CV9104 are capable of inducing adaptive immunity. Needle-free injection systems, like the Tropis® device for i.d. injection, overcome the disadvantages related to needle- and syringe-based i.d. injections. Tropis® is currently used in different vaccine clinical trials around the world. The use of Tropis® for i.d. delivery of CV9104 has been approved by BfArM.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Nationales Zentrum für Tumorerkrankungen, Medizinische Onkologie, Heidelberg, Baden-Württemberg, Germany
Klinik für Urologie, Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany
Klinikum rechts der Isar, Urologische Klinik und Poliklinik der Technischen Universität München, München, Bayern, Germany
Contact Details
Name: Arnulf Stenzl, Prof. Dr. med.
Affiliation: Klinik für Urologie, Universitätsklinikum Tübingen
Role: PRINCIPAL_INVESTIGATOR
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