MedTrace Logo

Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer

NCT04114825 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-09-28

No results posted yet for this study

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

  • Prostate Cancer Recurrent

Interventions

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

Sponsors & Collaborators

  • RhoVac APS

    lead INDUSTRY

Principal Investigators

  • Klaus Brasso, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2022-04-30
Completion
2022-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114825 on ClinicalTrials.gov