Vvax001 Cancer Vaccine in Premalignant Cervical Lesions - Phase II

NCT06015854 | Unknown Phase 2

• 1 other identifier: Vvax001-UMCG-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 three doses of Vvax001 immunization with an interval of 3 weeks between each immunization to induce histopathological regression and HPV clearance. Regression of CIN3 lesions will be monitored using colposcopy in week 9, week 17 and week 25. When complete regression of the CIN3 lesion is observed by colposcopy, a biopsy will be taken in week 25 to confirm regression histologically. A positive histologic regression is defined as a reduction from CIN3 to CIN1 or no dysplasia. Patients with a complete regression will not undergo the standard-of-care loop excision of the transformation zone (LETZ) and will be followed-up after the study by cytology at 3, 6 and 12 months. If complete regression has not occurred by 25 weeks, a standard-of-care LETZ will be performed.

Conditions

CIN3; Cervical Intraepithelial Neoplasia; Cervical Intraepithelial Neoplasia Grade 3; HPV 16 Infection

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy of Vvax001

  Clinical efficacy is determined by a pathological regression of the premalignant CIN3 lesion in pre- versus post-treatment tissue samples. A positive histologic regression is defined as a reduction from CIN3 to CIN1, or a reduction from CIN3 to no dysplasia.

  At week 25 (19 weeks after the last immunization)

Secondary Outcomes (3)

• Immunogenicity of Vvax001

  At weeks 7, 9, 17 and 25, respectively 1 week, 3 weeks, 11 weeks and 19 weeks after the last vaccination

• HPV 16 clearance

  Week 25 (19 weeks after the last immunization)

• Side effects/ adverse events

  up to 19 weeks after the last immunization

Study Arms (1)

HPV16+ CIN3

EXPERIMENTAL

Patients with histological proven HPV16-positive cervical intraepithelial neoplasia grade 3.

Biological: Vvax001 therapeutic cancer vaccine

Interventions

Vvax001 therapeutic cancer vaccine BIOLOGICAL

Patients will receive three immunizations, with an interval of 3 weeks between each immunization at weeks 0, 3 and 6. Each vaccination will be given as two injections; 1 injection in each leg. The injections will be administered intramuscularly in the upper legs, preferably in the m. vastus lateralis.

HPV16+ CIN3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator
• ViciniVax B.V: collaborator

Study Sites (1)

University Medical Center Groningen (UMCG)

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yigit

CONTACT

003153616161; r.yigit@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: March 23, 2021
• Primary Completion: February 6, 2024
• Study Completion: April 1, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

NL (1)