Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Vaccines

Monatide (IMS 3015)

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).

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).

RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).

RV001V

Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo

Placebo

Klaus Brasso, MD

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).

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)

Time to PSA progression is defined as the time from randomization to doubling of PSA from the baseline value. The time to doubling will be estimated from a log-linear regression of PSA values.

The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized

time from randomization to documented clinical recurrence (distant or local), or death from any cause, censoring at date of last follow-up (FU)

RhoVac APS

Neoplasm Metastasis

Neoplastic Processes

RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.

Jesper Sonne, MD, PhD

The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer

RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0

RV001-specific immunological response after treatment from baseline to each treatment and follow-up

Dantrials Aps

Non-TEAEs (Treatment Emergent Adverse Events) took place before the first vaccination.

TEAEs took place after first vaccination and up to start of follow up phase (Visit 13). Only related AEs and SAEs are to be captured in the follow up period.

RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.

RV001V: Sc injection

Experimental: RV001V

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Denmark

Region of Enrollment

Steven Glazer, MD

Proportions of Participants With Treatment-related Adverse Events

Immunological Response

RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.

RV001V: A total of 11 s.c.injection with RV001V. The first 6 injections were given every 2 weeks, whereas the remaining 5 vaccinations were administered with 4 weeks between each injection.

Spots Global Cancer Trial Database for rv001v

Every month we try and update this database with for rv001v cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer	NCT04114825	Prostate Cancer...	RV001V Placebo	18 Years -	RhoVac APS
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours	NCT03199872	Prostate Cancer	RV001V	18 Years -	RhoVac APS
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours	NCT03199872	Prostate Cancer	RV001V	18 Years -	RhoVac APS
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours	NCT03199872	Prostate Cancer	RV001V	18 Years -	RhoVac APS
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours	NCT03199872	Prostate Cancer	RV001V	18 Years -	RhoVac APS

Spots Global Cancer Trial Database for rv001v

Every month we try and update this database with for rv001v cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rv001v cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.