Back to resultsRV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
RV001V
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomised cancer patients
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.
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RV001V
Arm Description
RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
Outcomes
Primary Outcome Measures
Proportions of Participants With Treatment-related Adverse Events
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
Immunological Response
RV001-specific immunological response after treatment from baseline to each treatment and follow-up
Full Information
NCT ID
NCT03199872
First Posted
June 19, 2017
Last Updated
June 8, 2020
Sponsor
RhoVac APS
Collaborators
Dantrials Aps
1. Study Identification
Unique Protocol Identification Number
NCT03199872
Brief Title
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Official Title
A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
March 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RhoVac APS
Collaborators
Dantrials Aps
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatectomised cancer patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RV001V
Arm Type
Experimental
Arm Description
RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
Intervention Type
Biological
Intervention Name(s)
RV001V
Intervention Description
Sc injection
Primary Outcome Measure Information:
Title
Proportions of Participants With Treatment-related Adverse Events
Description
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
8 month
Secondary Outcome Measure Information:
Title
Immunological Response
Description
RV001-specific immunological response after treatment from baseline to each treatment and follow-up
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Sonne, MD, PhD
Organizational Affiliation
Dantrials Aps
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33184050
Citation
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.
Results Reference
derived
Learn more about this trial
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
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