RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Phase 1
Completed
- Conditions
- Prostate Cancer
- Interventions
- Biological: RV001V
- Registration Number
- NCT03199872
- Lead Sponsor
- RhoVac APS
- Brief Summary
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 22
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RV001V RV001V RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
- Primary Outcome Measures
Name Time Method Proportions of Participants With Treatment-related Adverse Events 8 month Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Secondary Outcome Measures
Name Time Method Immunological Response 12 months RV001-specific immunological response after treatment from baseline to each treatment and follow-up
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark