Clinical trial NCT03141463: Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CIN 2/3
Cervical Cancer
Keywords: Therapeutic vaccination
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: ViciniVax B.V
First posted: 2017-05-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Immunogenicity
timeFrame: Day 28-31 and day 49-52 after first administration of Vvax001
Secondary outcomes:
measure: Number of treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 49-52 days after first administration of Vvax001
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: R Yigit, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.