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

NCT01265368 | Completed Phase 1 DMC

• 2 other identifiers: MGN1601-CT12009-016853-16
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Stage IV Renal Cell Cancer

Keywords

Advanced Renal Cell Carcinoma; Tumor Vaccine; Cell-based Therapy

Outcome Measures

Primary Outcomes (1)

• Assessment of safety profile of MGN1601

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

Secondary Outcomes (4)

• 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

Study Arms (1)

Study medication

EXPERIMENTAL

Biological: MGN1601

Interventions

MGN1601 BIOLOGICAL

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)

Study medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mologen AG: lead

Study Sites (3)

Charité - Universtitäsmedizin Berlin, Klinik für Urologie

Berlin, 10117, Germany

Location

Universitätsklinikum Bonn, Med. Klinik und Poliklinik, Hämatologie und Onkologie

Bonn, 53127, Germany

Location

Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation OE6860

Hanover, 30625, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Viktor Grünwald, Prof. Dr.

  MHH Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

DE (3)