Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00831467 | Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease | PHASE1 | COMPLETED | 48 | — | — | Jan 1, 2009 | Sep 1, 2013 | Mar 20, 2018 | 12 | Germany, Italy |
| Arm | Type | Description |
|---|---|---|
| CV9103 | EXPERIMENTAL | CV9103 is applied intradermally into the thigh and upper arm of either side of the body at week 1, week 3, week 7, week 15, week 23 |
| Name | Type | Description |
|---|---|---|
| CV9103 | BIOLOGICAL | Over a period of 23 weeks 5 vaccinations with CV9103 will be administered. |
Inclusion Criteria: * Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation * Male and age ≥ 18 years (Phase I and II) and ≤ 75 years (Phase II only) * Histologically confirmed diagnosis of adenocarcinoma of the prostate, Gleason Score availab...