Prostate CancerPhase 1/2NCT03199872
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
A Phase 1/2 study testing RV001V in people with Prostate Cancer, run by RhoVac APS at 1 site in Denmark.
Trial summary
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- RV001V
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Mar 2017to 29 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- RV001V
- Keywords
- Prostatectomised cancer patients
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV001VBiological
Sc injection
| Study group | Role | What they receive |
|---|---|---|
| RV001V | Experimental | RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. Receives: Biological: RV001V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of Participants With Treatment-related Adverse Events
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 8 month
Secondary outcomes (1)
Immunological Response
RV001-specific immunological response after treatment from baseline to each treatment and follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start30 Mar 2017
- Primary completion1 Aug 2018
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- RhoVac APS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dantrials Aps
- Responsible party
- Sponsor
- Investigators
- Jesper Sonne, MD, PhD, Principal investigator, Dantrials Aps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199872
- Sponsor's protocol ID
- RhoVac-001
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2017
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33184050
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
- ClinicalTrials.gov ID
- NCT03199872
- Acronym / sponsor ID
- RhoVac-001
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomised cancer patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- RhoVac APSIndustry (pharma, biotech, devices)
- Collaborators
- Dantrials Aps
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV001V | Experimental | Biological: RV001VRV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV001VSc injection | Biological | RV001V |
Primary outcome
Proportions of Participants With Treatment-related Adverse Events
Time frame: 8 month
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 secondary outcome
Immunological Response
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33184050Schuhmacher 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.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Sonne, MD, PhD principal investigator
Dantrials Aps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RV001V in people with Prostate Cancer, run by RhoVac APS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of Participants With Treatment-related Adverse Events (time frame: 8 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.