Vvax001 Cancer Vaccine in Premalignant Cervical Lesions - Phase II

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new cancer vaccine called Vvax001 for women who have been newly diagnosed with a specific type of cervical condition known as CIN3, which is caused by the human papillomavirus (HPV) type 16. The goal of the trial is to see if this vaccine can help shrink these abnormal cells and clear the HPV infection. Participants will receive three doses of the vaccine, spaced three weeks apart, and their progress will be closely monitored through medical exams at different points during the study.

To participate, women must be at least 18 years old and have a recent diagnosis of HPV16-positive CIN3. They should not have had previous treatments for CIN lesions or certain other health issues that could affect their immune system. If the treatment is successful and the CIN3 lesions disappear, participants will not need the usual surgery to remove the affected area; instead, they will have follow-up tests to make sure everything remains normal. If the treatment does not work by the end of the study period, standard treatment will be provided. Overall, this trial offers a potential new approach to treating a condition that can lead to cervical cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.