Stage IV Renal Cell CancerPhase 1/2ASETNCT01265368
A Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine in Patients With Advanced Renal Cell Carcinoma (ASET)
A Phase 1/2 study testing MGN1601 in people with Stage IV Renal Cell Cancer, run by Mologen AG at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Renal Cell Cancer
- What is being tested?
- MGN1601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2010to Sep 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité - Universtitäsmedizin Berlin, Klinik für Urologie
Berlin, 10117
Universitätsklinikum Bonn, Med. Klinik und Poliklinik, Hämatologie und Onkologie
Bonn, 53127
Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation OE6860
Hanover, 30625
About this study
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)
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.
Read the 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.
- Conditions
- Stage IV Renal Cell Cancer
- Being tested
- MGN1601
- Keywords
- Advanced Renal Cell Carcinoma, Tumor Vaccine, Cell-based Therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGN1601Biological
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 group | Role | What they receive |
|---|---|---|
| Study medication | Experimental | Not described Receives: Biological: MGN1601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety profile of MGN1601
Measured: 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
Measured: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up (if applicable)
Assessment of the presence of MIDGE vectors
Measured: Treatment phase (12 weeks)
Assessment of the immune response to MGN1601
Measured: Treatment phase (12 weeks), extension phase (120 weeks, if applicable)
Evaluation of clinical and radiological response to MGN1601
Measured: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2013
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Renal Cell CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mologen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Viktor Grünwald, Prof. Dr., Principal investigator, MHH Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265368
- Sponsor's protocol ID
- MGN1601-CT1
- Other IDs
- 2009-016853-16, 2009
- Acronym
- ASET
- Status last verified
- Nov 2018
- First submitted
- 22 Dec 2010
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01265368
- Acronym / sponsor ID
- ASET / MGN1601-CT1
- Conditions
- Stage IV Renal Cell Cancer
- Keywords
- Advanced Renal Cell Carcinoma, Tumor Vaccine, Cell-based Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mologen AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2010 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study medication | Experimental | Biological: MGN1601 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGN1601Genetically 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) | Biological | Study medication |
Primary outcome
Assessment of safety profile of MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up
4 secondary outcomes
Assessment of potential autoimmune effects of MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up (if applicable)
Assessment of the presence of MIDGE vectors
Time frame: Treatment phase (12 weeks)
Assessment of the immune response to MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable)
Evaluation of clinical and radiological response to MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Grünwald, Prof. Dr. principal investigator
MHH Hannover
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MGN1601 in people with Stage IV Renal Cell Cancer, run by Mologen AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety profile of MGN1601 (time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.