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Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

Primary Purpose

CIN 2/3, Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Vvax001 therapeutic cancer vaccine
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CIN 2/3 focused on measuring Therapeutic vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vvax001 therapeutic cancer vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of treatment-related adverse events as assessed by CTCAE v4.0
To monitor the side effects/ adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Full Information

First Posted
March 16, 2017
Last Updated
May 2, 2018
Sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society, ViciniVax B.V
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1. Study Identification

Unique Protocol Identification Number
NCT03141463
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 13, 2017 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society, ViciniVax B.V

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIN 2/3, Cervical Cancer
Keywords
Therapeutic vaccination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vvax001 therapeutic cancer vaccine
Arm Type
Experimental
Arm Description
Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks
Intervention Type
Biological
Intervention Name(s)
Vvax001 therapeutic cancer vaccine
Other Intervention Name(s)
rSFVeE6,7
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunogenicity
Description
To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses
Time Frame
Day 28-31 and day 49-52 after first administration of Vvax001
Secondary Outcome Measure Information:
Title
Number of treatment-related adverse events as assessed by CTCAE v4.0
Description
To monitor the side effects/ adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time Frame
up to 49-52 days after first administration of Vvax001

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Yigit, MD PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
15535411
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.
Results Reference
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PubMed Identifier
17928874
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.
Results Reference
background
PubMed Identifier
26451295
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.
Results Reference
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Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

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