Trials / Active Not Recruiting
Active Not RecruitingNCT04114825
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men With Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer (BRaVac)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- RhoVac APS · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RV001V | RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V). |
| OTHER | Placebo | Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo |
Timeline
- Start date
- 2019-11-19
- Primary completion
- 2022-04-01
- Completion
- 2022-11-01
- First posted
- 2019-10-03
- Last updated
- 2021-09-28
Locations
36 sites across 7 countries: United States, Belgium, Denmark, Finland, Germany, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04114825. Inclusion in this directory is not an endorsement.