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

Sponsor

Mologen AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01265368

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Renal Cell Cancer	Biological: MGN1601	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Assessment of safety profile of MGN1601 [Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charité - Universtitäsmedizin Berlin, Klinik für Urologie	Berlin	Germany	10117
2	Universitätsklinikum Bonn, Med. Klinik und Poliklinik, Hämatologie und Onkologie	Bonn	Germany	53127
3	Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation OE6860	Hannover	Germany	30625