Clinical Trials Logo
  1. Home
  2. Prostate Carcinoma
  3. NCT02140138

An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:
An Open Label Randomised Phase II Trial of RNActive® Cancer Vaccine (CV9104) in High Risk and Intermediate Risk Patients With Prostate Cancer

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02140138
Study type Interventional
Source CureVac AG
Contact
Status Terminated
Phase Phase 2
Start date June 2014
Completion date April 2016
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04457232 - Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation Phase 1
Active, not recruiting NCT03661437 - Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy Early Phase 1
Completed NCT02337465 - KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer N/A
Completed NCT03013413 - Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy N/A
Recruiting NCT06037863 - Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial N/A
Active, not recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Completed NCT03326440 - Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer N/A
Recruiting NCT04597359 - To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring Phase 2
Active, not recruiting NCT03263650 - Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC Phase 2
Active, not recruiting NCT04600336 - Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer Phase 2
Active, not recruiting NCT04299620 - Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy N/A
Completed NCT04976257 - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion Early Phase 1
Completed NCT02957981 - The Genetic Education for Men Trial: Web-Based Education vs. Standard Care N/A
Withdrawn NCT03408561 - Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer N/A
Enrolling by invitation NCT06347809 - DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Enrolling by invitation NCT04254133 - Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Recruiting NCT05519878 - Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers N/A
Recruiting NCT02994758 - Development of Diagnostics and Treatment of Urological Cancers N/A
Completed NCT01497431 - Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants Phase 1
Active, not recruiting NCT00002540 - Screening for Prostate Cancer in Older Patients (PLCO Screening Trial) N/A