Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions
NCT ID: NCT03141463
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2017-01-13
2017-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vvax001 therapeutic cancer vaccine
Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Dutch Cancer Society
OTHER
ViciniVax B.V
UNKNOWN
University Medical Center Groningen
OTHER
Responsible Party
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Refika Yigit
MD PhD
Principal Investigators
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R Yigit, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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References
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Daemen T, Riezebos-Brilman A, Regts J, Dontje B, van der Zee A, Wilschut J. Superior therapeutic efficacy of alphavirus-mediated immunization against human papilloma virus type 16 antigens in a murine tumour model: effects of the route of immunization. Antivir Ther. 2004 Oct;9(5):733-42.
Riezebos-Brilman A, Walczak M, Regts J, Rots MG, Kamps G, Dontje B, Haisma HY, Wilschut J, Daemen T. A comparative study on the immunotherapeutic efficacy of recombinant Semliki Forest virus and adenovirus vector systems in a murine model for cervical cancer. Gene Ther. 2007 Dec;14(24):1695-704. doi: 10.1038/sj.gt.3303036. Epub 2007 Oct 11.
Draghiciu O, Boerma A, Hoogeboom BN, Nijman HW, Daemen T. A rationally designed combined treatment with an alphavirus-based cancer vaccine, sunitinib and low-dose tumor irradiation completely blocks tumor development. Oncoimmunology. 2015 May 27;4(10):e1029699. doi: 10.1080/2162402X.2015.1029699. eCollection 2015 Oct.
Other Identifiers
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2015-004979-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL56680.000.16
Identifier Type: OTHER
Identifier Source: secondary_id
Vvax001-UMCG-01
Identifier Type: -
Identifier Source: org_study_id
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