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.

Phase 2

Recruiting

Conditions: cervical neoplasia / cervical cancer
10019815
10038594

Registration Number: NL-OMON55191

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 18

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.
* 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint is clinical efficacy of Vvax001. To assess vaccine<br /><br>induced clinical responses, histology of the pre-treatment diagnostic biopsy<br /><br>will be compared to histology of the post- treatment therapeutic biopsy/LLETZ.<br /><br>A positive response is defined as a reduction from CIN3 to CIN1, or a change<br /><br>from CIN3 to no dysplasia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are 1) the immunological activity of Vvax001 by monitoring<br /><br>HPV-16 E6,7-specific T-cell immune responses in peripheral blood at baseline,<br /><br>week 7, week 9, week 17 and week 25; 2) HPV16 clearance; and 3) potential side<br /><br>effects/adverse events related to Vvax001.</p><br>