Advanced Solid TumorsPhase 1NCT01012102
EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors
A Phase 1 study testing EMD 640744 and Montanide ISA 51 VG in people with Advanced Solid Tumors, run by Merck KGaA, Darmstadt, Germany.
Trial summary
To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy. The primary target variable is the immune response as assessed by ELISPOT before and until week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- EMD 640744 and Montanide ISA 51 VG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Sep 2011
- Phase
- Phase 1
- 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 ≥18 years of age
- Signed written informed consent
- Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists
- Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity
- Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7 assessed by HLAgenotyping
- ECOG performance status of ≤1, estimated life expectancy of at least 3 months
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- Adequate hematological function defined by WBC ≥3 x 10x9/L, lymphocyte count ≥0.5 x 10x9/L, hemoglobin ≥10 g/dL, platelet count ≥100 x 10x9/L
- Adequate blood coagulation parameters defined as aPTT and INR ≤ 1.5 x ULN
- Adequate renal function defined by a serum creatinine ≤2 x ULN
- Adequate hepatic function defined by total bilirubin ≤2 x ULN and AST and ALT levels ≤2.5 x ULN (in subjects with liver metastases ≤5 x ULN)
- Effective contraception for female and male subjects if the risk of conception exists
Who cannot join
- Treatment in another clinical study within the past 30 days prior to the first administration of study treatment
- Previous treatment with an investigational anticancer vaccine
- Requirement of concurrent treatment with a nonpermitted drug
- Active significant autoimmune disease (with the exception of vitiligo)
- Receipt of allogeneic stem cell transplantation
- Significant acute or chronic infections (e.g. viral hepatitis, HIV)
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- Primary brain tumors and brain metastases (with the exception of brain metastases that are stable after irradiation or surgically resected brain metastases if subjects have been asymptomatic for ≥6 months)
- Rapidly progressive disease (e.g. tumor lysis syndrome)
- Radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy), immunotherapy or any investigational drug within 30 days before the start of study treatment
- Pregnancy or lactation
- Active drug or alcohol abuse
- Known hypersensitivity to the study treatment or any of its components
- Any significant disease that, in the Investigator's opinion, should exclude the subject from the study; for questions about this criterion, the Investigator should contact the sponsor.
- Persisting toxicity related to prior therapy ≥grade 2 National Cancer Institute-Common Terminology Criteria For Adverse Events version 3.0
- Legal incapacity or limited legal capacity
About this study
Official title: An Open Label, Parallel Group, Randomized Phase I Study of Biological Activity, Safety, Tolerability, and Clinical Activity of Different Dose Levels of EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors
To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy.
The primary target variable is the immune response as assessed by ELISPOT before and until week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG.
- Conditions
- Advanced Solid Tumors
- Being tested
- EMD 640744, Montanide ISA 51 VG
- Keywords
- EMD 640744, Montanide, Advanced solid tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMD 640744Biological
EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744Biological
EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744Biological
EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Montanide ISA 51 VGOther
Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
Montanide ISA 51 VGOther
Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)
Montanide ISA 51 VGOther
Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | EMD 640744 30μg and Montanide® ISA 51 VG Receives: Biological: EMD 640744; Other: Montanide ISA 51 VG |
| Group 2 | Experimental | EMD 640744 100μg and Montanide® ISA 51 VG Receives: Biological: EMD 640744; Other: Montanide ISA 51 VG |
| Group 3 | Experimental | EMD 640744 300μg and Montanide® ISA 51 VG Receives: Biological: EMD 640744; Other: Montanide ISA 51 VG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy
Measured: 1-4 weeks
Secondary outcomes (2)
To assess the safety and tolerability of different doses of EMD 640744 in Montanide® ISA 51 VG in terms of laboratory parameters and adverse event profile.
Measured: 3 months
To assess the clinical efficacy in terms of the overall response, progression-free survival time, and survival time.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens-Peter Marschner, MD, Study director, Merck KGaA, Darmstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012102
- Sponsor's protocol ID
- EMR 200032-001
- Status last verified
- Oct 2011
- First submitted
- 20 Oct 2009
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lennerz V, Gross S, Gallerani E, Sessa C, Mach N, Boehm S, Hess D, von Boehmer L, Knuth A, Ochsenbein AF, Gnad-Vogt U, Zieschang J, Forssmann U, Woelfel T, Kaempgen E. Immunologic response to the survivin-derived multi-epitope vaccine EMD640744 in patients with advanced solid tumors. Cancer Immunol Immunother. 2014 Apr;63(4):381-94. doi: 10.1007/s00262-013-1516-5. Epub 2014 Feb 2.
PubMed 24487961
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Parallel Group, Randomized Phase I Study of Biological Activity, Safety, Tolerability, and Clinical Activity of Different Dose Levels of EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01012102
- Acronym / sponsor ID
- EMR 200032-001
- Conditions
- Advanced Solid Tumors
- Keywords
- EMD 640744, Montanide, Advanced solid tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Nov 2009 (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.
To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy.
The primary target variable is the immune response as assessed by ELISPOT before and until week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: EMD 640744, Other: Montanide ISA 51 VGEMD 640744 30μg and Montanide® ISA 51 VG |
| Group 2 | Experimental | Biological: EMD 640744, Other: Montanide ISA 51 VGEMD 640744 100μg and Montanide® ISA 51 VG |
| Group 3 | Experimental | Biological: EMD 640744, Other: Montanide ISA 51 VGEMD 640744 300μg and Montanide® ISA 51 VG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects ≥18 years of age
- Signed written informed consent
- Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists
- Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity
- Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7 assessed by HLAgenotyping
Key exclusion criteria (15 listed)
- Treatment in another clinical study within the past 30 days prior to the first administration of study treatment
- Previous treatment with an investigational anticancer vaccine
- Requirement of concurrent treatment with a nonpermitted drug
- Active significant autoimmune disease (with the exception of vitiligo)
- Receipt of allogeneic stem cell transplantation
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 |
|---|---|---|
| EMD 640744EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG) | Biological | Group 1 |
| EMD 640744EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG) | Biological | Group 2 |
| EMD 640744EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG) | Biological | Group 3 |
| Montanide ISA 51 VGAdjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug) | Other | Group 1 |
| Montanide ISA 51 VGAdjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug) | Other | Group 2 |
| Montanide ISA 51 VGAdjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug) | Other | Group 3 |
Primary outcome
To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy
Time frame: 1-4 weeks
2 secondary outcomes
To assess the safety and tolerability of different doses of EMD 640744 in Montanide® ISA 51 VG in terms of laboratory parameters and adverse event profile.
Time frame: 3 months
To assess the clinical efficacy in terms of the overall response, progression-free survival time, and survival time.
Time frame: 3 months
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 20 Feb 2014.
- Results publication: PubMed 24487961Lennerz V, Gross S, Gallerani E, Sessa C, Mach N, Boehm S, Hess D, von Boehmer L, Knuth A, Ochsenbein AF, Gnad-Vogt U, Zieschang J, Forssmann U, Woelfel T, Kaempgen E. Immunologic response to the survivin-derived multi-epitope vaccine EMD640744 in patients with advanced solid tumors. Cancer Immunol Immunother. 2014 Apr;63(4):381-94. doi: 10.1007/s00262-013-1516-5. Epub 2014 Feb 2.
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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.
Jens-Peter Marschner, MD study director
Merck KGaA, Darmstadt
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMD 640744 and Montanide ISA 51 VG in people with Advanced Solid Tumors, run by Merck KGaA, Darmstadt, 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 11 inclusion and 15 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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy (time frame: 1-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01012102, which also lists 1 linked publication.
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 20 Feb 2014.