Phase 2
Completed N=22
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Source: ClinicalTrials.gov NCT03199872 ↗Enrolled (actual)
22
Serious AEs
18.2%
Results posted
Jun 2020
Primary outcomePrimary: Proportions of Participants With Treatment-related Adverse Events — 22 Participants
Summary
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportions of Participants With Treatment-related Adverse Events |
22 | — |
| SECONDARY Immunological Response |
18 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03199872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.