A Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine in Patients With Advanced Renal Cell Carcinoma (ASET) (ASET)

November 13, 2018 updated by: Mologen AG

A Phase 1/2, Proof-of-Principle, Multi-Center, Open-Label, Single-Arm, Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Allogeneic (Human) Tumor Cells for the Expression of IL-7, GM-CSF, CD80 and CD154, in Fixed Combination With a DNA-based Double Stem Loop Immunomodulator in Patients With Advanced Renal Cell Carcinoma (ASET Study)

This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients with advanced renal cell carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty four patients with advanced RCC will be included in this open, single-arm study.

The treatment will last 12 weeks. The investigational product (MGN1601) will be administered intradermally for a total of 8 applications, whereas the first 3 applications will be administered weekly, and the following 5 applications will be administered bi-weekly.

Patients who will develop disease control (CR, PR, or SD) by week 12 will be proposed to participate in the extension phase of the study. The extension phase will be continued until disease progression in each patient, however, maximally up to week 120 (total treatment duration 2.5 years). During this time period the investigational product will be administered 5 times by weeks 24, 36, 48, 72, and 120.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universtitäsmedizin Berlin, Klinik für Urologie
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn, Med. Klinik und Poliklinik, Hämatologie und Onkologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation OE6860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects older than 18 years of age
  • Histologically confirmed renal cell carcinoma
  • Radiologically confirmed advanced disease defined as unresectable locally reccurrent or metastatic disease (AJCC Stage IV)
  • Previous nephrectomy
  • No standard therapy is available for the patient
  • At least 4 weeks after previous radiotherapy prior to study treatment
  • At least 1 week after previous systemic therapy prior to study treatment
  • At least one lesion measurable by modified RECIST criteria
  • ECOG performance status 0-1
  • Adequate organ function including hematopoietic organs
  • MSKCC prognostic ctiteria < 3 predictors of short survival
  • Negative urine pregnancy test in women with childbearing potential
  • Women of childbearing potential and all male participants are willing to use acceptable methods of contraception (birth control pills, barriers)
  • Expected adequacy of follow-up
  • Signed informed consent form (ICF).

Exclusion Criteria:

  • Clinically significant concomitant diseases or conditions unrelated to the underlying malignancy or therapy, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
  • Known hypersensitivity to any component of the study drug
  • Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
  • Active brain metastases except adequately treated brain metastases with no progression for at least 3 months
  • Active or uncontrolled infections
  • Transfusion-dependent anemia
  • History of autoimmune disease or immune deficiency
  • Concurrent chronic systemic immune therapy, corticosteroids or other immunosuppressant medication
  • Concurrent radiotherapy within the last 4 weeks prior to study treatment and/or during the course of the study
  • Concurrent immunotherapy or targeted therapy within the last 1 week prior to study treatment and/or during the course of the study
  • HIV seropositivity or active hepatitis B or C infection
  • Planned major surgery during the study
  • Participation in other clinical studies during this clinical study
  • Vaccination within 3 months prior to the first treatment day
  • Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
  • Pregnancy and/or nursing
  • Presence of drug and/or alcohol abuse
  • Commitment to an institution by virtue of an order issued either by judicial or administrative authorities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study medication
Biological: MGN1601
Genetically modified allogeneic (human) tumor cells for the expression of IL-7, GM-CSF, CD80 and CD154, in fixed combination with a DNA-based double stem loop immunomodulator (dSLIM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of safety profile of MGN1601
Time Frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up
Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of potential autoimmune effects of MGN1601
Time Frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up (if applicable)
Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up (if applicable)
Assessment of the presence of MIDGE vectors
Time Frame: Treatment phase (12 weeks)
Treatment phase (12 weeks)
Assessment of the immune response to MGN1601
Time Frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable)
Treatment phase (12 weeks), extension phase (120 weeks, if applicable)
Evaluation of clinical and radiological response to MGN1601
Time Frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up
Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mologen AG

Investigators

  • Principal Investigator: Viktor Grünwald, Prof. Dr., MHH Hannover

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGN1601-CT1
  • 2009-016853-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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