NCT03141463

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

May 3, 2018

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

March 16, 2017

Last Update Submit

May 2, 2018

Conditions

CIN 2/3Cervical Cancer

Keywords

Therapeutic vaccination

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity

    To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses

    Day 28-31 and day 49-52 after first administration of Vvax001

Secondary Outcomes (1)

  • Number of treatment-related adverse events as assessed by CTCAE v4.0

    up to 49-52 days after first administration of Vvax001

Study Arms (1)

Vvax001 therapeutic cancer vaccine

EXPERIMENTAL

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

Biological: Vvax001 therapeutic cancer vaccine

Interventions

Vvax001 therapeutic cancer vaccineBIOLOGICAL

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.

Also known as: rSFVeE6,7
Vvax001 therapeutic cancer vaccine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 15535411BACKGROUND

  • 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.

    PMID: 17928874BACKGROUND

  • 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.

    PMID: 26451295BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • R Yigit, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 16, 2017

First Posted

May 5, 2017

Study Start

January 13, 2017

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

May 3, 2018

Record last verified: 2017-11

Locations

NL(1)