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

Phase 2CompletedNCT03199872

RhoVac APS22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

RV001VBIOLOGICAL

Sc injection

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment. * ECOG performance status 0 or 1. Exclusion Criteria: * Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment. * Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Proportions of Participants With Treatment-related Adverse Events

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

Time frame: 8 month

Secondary Outcomes

Immunological Response

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

Time frame: 12 months

Data from ClinicalTrials.gov

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