- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012102
EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors
February 19, 2014 updated by: Merck KGaA, Darmstadt, Germany
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
EMD 640744 30μg and Montanide® ISA 51 VG
|
EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)
|
Experimental: Group 2
EMD 640744 100μg and Montanide® ISA 51 VG
|
EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)
|
Experimental: Group 3
EMD 640744 300μg and Montanide® ISA 51 VG
|
EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug)
Adjuvant.
Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
To assess the clinical efficacy in terms of the overall response, progression-free survival time, and survival time.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jens-Peter Marschner, MD, Merck KGaA, Darmstadt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
October 20, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Estimate)
February 20, 2014
Last Update Submitted That Met QC Criteria
February 19, 2014
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR 200032-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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