Clinical trial · Interventional
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
NCT03199872CI-TRIAL-00045473completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RV001V | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RV001V
- description
- RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
- interventionNames
- Biological: RV001V
Primary outcomes (1)
- measure
- Proportions of Participants With Treatment-related Adverse Events
- timeFrame
- 8 month
- description
- Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcomes (1)
- measure
- Immunological Response
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSchuhmacher J, Heidu S, Balchen T, Richardson JR, Schmeltz C, Sonne J, Schweiker J, Rammensee HG, Thor Straten P, Roder MA, Brasso K, Gouttefangeas C. Vaccination against RhoC induces long-lasting immune responses in patients with prostate cancer: results from a phase I/II clinical trial. J Immunother Cancer. 2020 Nov;8(2):e001157. doi: 10.1136/jitc-2020-001157. PMID 33184050