Advanced renal cell carcinoma MedDRA version: 17.0 Level: PT Classification code 10038394 Term: Renal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: MGN1601
Pharmaceutical Form: Suspension for injection
Current Sponsor code: MGN1601-W1
Other descriptive name: Genetically modified allogeneic (human) tumour cells for the expr. of IL-7,
Sponsors
MOLOGEN AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects older than 18 years of age 2. Histologically confirmed renal cell carcinoma 3. Radiologically confirmed advanced disease defined as unresectable locally reccurrent or metastatic disease (AJCC Stage IV) 4. Previous nephrectomy 5. No standard therapy is available for the patient 6. At least 4 weeks after previous radiotherapy prior to study treatment 7. At least 1 week after previous systemic therapy prior to study treatment 8. At least one lesion measurable by modified RECIST criteria 9. ECOG performance status 0-1 10. Adequate organ function including hematopoietic organs 11. MSKCC prognostic ctiteria =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. 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 2. Known hypersensitivity to any component of the study drug 3. 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 4. Active brain metastases except adequately treated brain metastases with no progression for at least 3 months 5. Active or uncontrolled infections 6. Transfusion-dependent anemia 7. History of autoimmune disease or immune deficiency 8. Concurrent chronic systemic immune therapy, corticosteroids or other immunosuppressant medication 9. Concurrent radiotherapy within the last 4 weeks prior to study treatment and/or during the course of the study 10. Concurrent immunotherapy or targeted therapy within the last 1 week prior to study treatment and/or during the course of the study 11. HIV seropositivity or active hepatitis B or C infection 12. Planned major surgery during the study 13. Participation in other clinical studies during this clinical study 14. Vaccination within 3 months prior to the first treatment day 15. 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 16. Pregnancy and/or nursing 17. Presence of drug and/or alcohol abuse 18. Commitment to an institution by virtue of an order issued either by judicial or administrative authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up. ;Main Objective: The aim of the proposed clinical study is to evaluate the safety of intradermally administered MGN1601 in patients with advanced renal cell carcinoma (AJCC Stage IV).;Secondary Objective: The second objectives of this study are: - to evaluate immunological activity - to evaluate potential therapeutic benefit of the chosen treatment schedule with MGN1601 in this patient population.;Primary end point(s): The primary safety variable in this clinical study is the assessment of adverse event rates graded according to NCI CTC version 4.0 based on changes of clinical parameters and clinically relevant laboratory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - assessment of possible autoimmunity of MGN1601; - assessment of the MIDGE vectors in serum samples; - assessment of the of clinical and radiological response to MGN1601; - assessment of the immune response to MGN1601. ;Timepoint(s) of evaluation of this end point: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up. | — |
Countries
Germany
Contacts
Public ContactInformation desk
MOLOGEN AG
Outcome results
None listed