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RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199872
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Dantrials Aps
Information provided by (Responsible Party):
RhoVac APS

Brief Summary:
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: RV001V Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RV001V
RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
Biological: RV001V
Sc injection




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 8 month ]
    Safety and tolerability (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)


Secondary Outcome Measures :
  1. Immunological response [ Time Frame: 20 months ]
    RV001-specific immunological response before, during and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199872


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2400
Sponsors and Collaborators
RhoVac APS
Dantrials Aps
Investigators
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Principal Investigator: Jesper Sonne, MD, PhD Dantrials Aps

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Responsible Party: RhoVac APS
ClinicalTrials.gov Identifier: NCT03199872     History of Changes
Other Study ID Numbers: RhoVac-001
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Vaccines
Immunologic Factors
Physiological Effects of Drugs