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Cancer Vaccine

RV001V for Prostate Cancer (BRaVac Trial)

Phase 2
Waitlist Available
Led By Klaus Brasso, MD
Research Sponsored by RhoVac APS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

BRaVac Trial Summary

This trial will enroll adult male patients who have had prostate cancer surgery or radiation, and the cancer has come back. The trial will test a cancer vaccine.

Eligible Conditions
  • Prostate Cancer

BRaVac Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to PSA progression
Secondary outcome measures
Disease-free survival (DFS)
Proportion of patients showing a PSA response from baseline
Safety by frequency and severity of adverse events (AEs)
+1 more

Side effects data

From 2019 Phase 1 & 2 trial • 22 Patients • NCT03199872
100%
Injection site reaction
9%
Arthralgia
5%
Impaired healing
5%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: RV001V

BRaVac Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RV001VExperimental Treatment1 Intervention
Total of 12 SC vaccinations with RV001V. The first 6 vaccinations (priming period) will be given every 2 weeks, and then the following 5 vaccinations (7 through 11) will be administered with 4 weeks between each vaccination (Maintenance period), and the last vaccination (12th) will be administered 6 months following the 11th vaccination (boosting injection).
Group II: PlaceboPlacebo Group1 Intervention
Total of 12 SC vaccinations with placebo. The first 6 vaccinations (priming period) will be given every 2 weeks, and then the following 5 vaccinations (7 through 11) will be administered with 4 weeks between each vaccination (Maintenance period), and the last vaccination (12th) will be administered 6 months following the 11th vaccination (boosting injection).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RV001V
2017
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

RhoVac APSLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Prostate Cancer
22 Patients Enrolled for Prostate Cancer
Klaus Brasso, MDPrincipal InvestigatorRigshospitalet, Denmark

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer
2019. "Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04114825.
~33 spots leftby Apr 2025
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