Status:
COMPLETED
A Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine in Patients With Advanced Renal Cell Carcinoma (ASET)
Lead Sponsor:
Mologen AG
Conditions:
Stage IV Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 rena...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01265368
Start Date
November 1 2010
End Date
September 1 2018
Last Update
November 15 2018
Active Locations (3)
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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
Hanover, Germany, 30625