EUCTR2019-004050-29-NLActive, not recruitingPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
- •* Clinically significant findings as judged by the investigator on screening/study entry including those from biochemistry, haematology and urinalysis performed at screening.
- •* Any condition that in the opinion of the investigator could interfere with the conduct of the study.
- •* Pregnancy.
Investigators
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