Skip to main content
Clinical Trials/NCT03141463
NCT03141463CompletedPhase 1

Immune Modulating Effects and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With a History of (Pre) Malignant Cervical Lesions.

University Medical Center Groningen2 sites in 1 country12 target enrollmentStarted: January 13, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
Immunogenicity

Study Overview

Brief Summary

Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.

Detailed Description

Vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A history of CIN II and III OR cervical cancer
  • Minimally 12 weeks after completion of treatment
  • Age of 18 years and older
  • Baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, HIV- and HBV-negative
  • Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study
  • Written informed consent according to local guidelines

Exclusion Criteria

  • Prior treatment with immunotherapeutic agents against HPV
  • History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy.
  • History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type
  • Participation in a study with another investigational drug within 30 days prior to the enrolment in this study
  • Any condition that in the opinion of the investigator could interfere with the conduct of the study

Arms & Interventions

Vvax001 therapeutic cancer vaccine

Experimental

Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks

Intervention: Vvax001 therapeutic cancer vaccine (Biological)

Outcomes

Primary Outcomes

Immunogenicity

Time Frame: Day 28-31 and day 49-52 after first administration of Vvax001

To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses

Secondary Outcomes

  • Number of treatment-related adverse events as assessed by CTCAE v4.0(up to 49-52 days after first administration of Vvax001)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Refika Yigit

MD PhD

University Medical Center Groningen

Study Sites (2)

Loading locations...

Similar Trials