A phase II study investigating the efficacy and safety of Vvax001, a therapeutic cancer vaccine, in patients with premalignant cervical lesions.

Phase 1

• Conditions: HPV-16 induced pre malignant cervical lesions; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004050-29-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• 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.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified