drugset / Trial / NCT02140138

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

NCT02140138 ↗

Phase 2 Terminated 35 enrolled CureVac
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-06
Primary completion
2016-04
Completion
2016-04

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment was terminated after enrolment of 35 instead of 36 evaluable patients for administrative reasons.”

Drugs

EvaluationDrugModalityDoseRoute
Subject CV9104 Messenger RNA (mRNA) 160 ug Other
Subject CV9104 Messenger RNA (mRNA) 320 ug Other

Indications