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

RhoVac

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Biological: RV001V

Study type: Interventional

Funder types: Industry

Identifiers

NCT03199872

RhoVac-001

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

RV001V

Experimental group

Description:

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

Treatment:

Biological: RV001V