Trial | NCT03141463  Report issue

Title

Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions
Immune Modulating Effects and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With a History of (Pre) Malignant Cervical Lesions.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vvax001 ...

  • Study Participants

    12
Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.
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.
Study Started
Jan 13
2017
Primary Completion
Nov 28
2017
Study Completion
Nov 28
2017
Last Update
May 03
2018

Biological Vvax001 therapeutic cancer vaccine

Vvax001 is a 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.

  • Other names: rSFVeE6,7

Vvax001 therapeutic cancer vaccine Experimental

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

Criteria 

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
No Results Posted