NL-OMON55191
Recruiting
Phase 2
A phase II study to determine the efficacy and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with HPV-16 induced grade 3 cervical intraepithelial neoplasia. - Vvax001 cancer vaccine in HPV-16 related disease.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult female patients (\>\=18 years) who have newly been diagnosed with HPV\-16
- •positive CIN3 lesions and have signed written informed consent according to
- •local guidelines. Patients of child\-bearing potential should test negative
- •using a pregnancy test and agree to utilize effective contraception during the
- •entire treatment and follow\-up period of the study.
Exclusion Criteria
- •\* PAP5 lesions.
- •\* Previously undergone treatment for CIN lesions.
- •\* Adenocarcinoma in situ within CIN3 lesion
- •\* History of 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 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.
Outcomes
Primary Outcomes
Not specified
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