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
Refika Yigit
MD PhD
University Medical Center Groningen
Study Sites (2)
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