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

Prostate Cancer Clinical Trial

Official title:

A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199872
• Other study ID #: RhoVac-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 30, 2017
• Est. completion date: March 29, 2019

Study information

• Verified date: June 2020
• Source: RhoVac APS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 29, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• RV001V
Sc injection

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
RhoVac APS	Dantrials Aps

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunological Response	RV001-specific immunological response after treatment from baseline to each treatment and follow-up	12 months