Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 1

Conditions: CIN 2/3; Cervical Cancer

Treatments: Biological: Vvax001 therapeutic cancer vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03141463

NL56680.000.16 (Other Identifier)

Vvax001-UMCG-01

2015-004979-74 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Vvax001 therapeutic cancer vaccine

Experimental group

Description:

Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks

Treatment:

Biological: Vvax001 therapeutic cancer vaccine