Cancer vaccine for treating premalignant cervical lesions
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
This study is testing a new cancer vaccine to see if it can help people with early-stage cervical lesions caused by HPV16 get better without needing surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06015854 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with newly diagnosed HPV16-positive CIN3.
Not a fit: Patients with PAP5 lesions or those who have previously undergone treatment for CIN lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a non-surgical treatment option for patients with premalignant cervical lesions, reducing the risk of complications associated with surgery.
How similar studies have performed: Previous studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Groningen
- University Medical Center Groningen (UMCG) — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Yigit
- Email: r.yigit@umcg.nl
- Phone: 003153616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.