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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage IV Renal Cell Cancer

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Trial Information

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)


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of safety profile of MGN1601

Outcome Time Frame:

Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up

Safety Issue:

Yes

Principal Investigator

Steffen Weikert, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité - Universtitäsmedizin Berlin, Klinik für Urologie

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

MGN1601-CT1

NCT ID:

NCT01265368

Start Date:

December 2010

Completion Date:

November 2019

Related Keywords:

  • Stage IV Renal Cell Cancer
  • Advanced Renal Cell Carcinoma
  • Tumor Vaccine
  • Cell-based Therapy
  • Carcinoma
  • Carcinoma, Renal Cell

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