Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

Phase 1

Completed

• Conditions: CIN 2/3; Cervical Cancer
• Interventions: Biological: Vvax001 therapeutic cancer vaccine

• Registration Number: NCT03141463
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.

Detailed Description

Vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-13
• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Status Verified: 2017-11
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• A history of CIN II and III OR cervical cancer
• Minimally 12 weeks after completion of treatment
• Age of 18 years and older
• Baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, HIV- and HBV-negative
• 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

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Exclusion Criteria

• Prior treatment with immunotherapeutic agents against HPV
• 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 second 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
• Any condition that in the opinion of the investigator could interfere with the conduct of the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vvax001 therapeutic cancer vaccine	Vvax001 therapeutic cancer vaccine	Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks

Primary Outcome Measures

Name	Time	Method
Immunogenicity	Day 28-31 and day 49-52 after first administration of Vvax001	To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses

Secondary Outcome Measures

Name	Time	Method
Number of treatment-related adverse events as assessed by CTCAE v4.0	up to 49-52 days after first administration of Vvax001	To monitor the side effects/ adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands