Cancer vaccine for treating premalignant cervical lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the efficacy of the Vvax001 cancer vaccine in patients with newly diagnosed HPV16-induced cervical intraepithelial neoplasia grade 3 (CIN3). Participants will receive three doses of the vaccine, administered three weeks apart, to stimulate an immune response aimed at regressing CIN3 lesions and clearing HPV. The effectiveness of the treatment will be monitored through colposcopy and biopsy at specified intervals to assess histopathological regression. If successful, patients may avoid standard surgical interventions typically required for CIN3.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Medical Center Groningen (UMCG)
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Yigit
• Email: r.yigit@umcg.nl
• Phone: 003153616161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.