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
1 other identifier
interventional
22
1 country
1
Brief Summary
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 prostate-cancer
Started Mar 2017
Shorter than P25 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2017
CompletedFirst Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedResults Posted
Study results publicly available
June 9, 2020
CompletedJune 9, 2020
June 1, 2020
1.3 years
June 19, 2017
October 16, 2019
June 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportions of Participants With Treatment-related Adverse Events
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
8 month
Secondary Outcomes (1)
Immunological Response
12 months
Study Arms (1)
RV001V
EXPERIMENTALRV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RhoVac APSlead
- Dantrials Apscollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, 2400, Denmark
Related Publications (1)
Schuhmacher 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: 33184050DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven Glazer, MD
- Organization
- RhoVac ApS
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper Sonne, MD, PhD
Dantrials Aps
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
June 27, 2017
Study Start
March 30, 2017
Primary Completion
August 1, 2018
Study Completion
March 29, 2019
Last Updated
June 9, 2020
Results First Posted
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share