Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

All Drugs and Chemicals

Vaccines

Monatide (IMS 3015)

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

RV001V

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

RhoVac 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.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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 prostatectomised cancer patients