Status:
UNKNOWN
Vvax001 Cancer Vaccine in Premalignant Cervical Lesions - Phase II
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Dutch Cancer Society
ViciniVax B.V
Conditions:
CIN3
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is an open label phase II study in patients with newly diagnosed human papilloma virus type 16 (HPV16) induced cervical intraepithelial neoplasia grade 3 (CIN3). Patients will be treated with thr...
Detailed Description
Human papillomavirus (HPV) infection is the most important cause of premalignant cervical disease. Current treatment for premalignant HPV-induced genital lesions primarily relies on surgery, which can...
Eligibility Criteria
Inclusion
- Newly diagnosed HPV16-positive CIN3.
- Age of 18 years and older.
- 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
- PAP5 lesions.
- Previously undergone treatment for CIN lesions.
- Adenocarcinoma in situ within CIN3 lesion.
- 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 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 the Biochemistry, Hematology and urinalysis performed at baseline.
- Any condition that in the opinion of the investigator could interfere with the conduct of the study.
- Pregnancy.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06015854
Start Date
March 23 2021
End Date
April 1 2024
Last Update
August 29 2023
Active Locations (1)
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1
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9700 RB