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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | EMD 640744 30μg and Montanide® ISA 51 VG |
|
| Group 2 | Experimental | EMD 640744 100μg and Montanide® ISA 51 VG |
|
| Group 3 | Experimental | EMD 640744 300μg and Montanide® ISA 51 VG |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMD 640744 | Biological | EMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG) |
|
| Measure | Description | 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 | 1-4 weeks |
| Measure | Description | 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. | 3 months | |
| To assess the clinical efficacy in terms of the overall response, progression-free survival time, and survival time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens-Peter Marschner, MD | Merck KGaA, Darmstadt | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24487961 | Result | 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. |
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| ID | Term |
|---|---|
| C477385 | montanide ISA 51 |
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| EMD 640744 | Biological | EMD 640744 100μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG) |
|
| EMD 640744 | Biological | EMD 640744 300μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG) |
|
| Montanide ISA 51 VG | Other | Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug) |
|
| Montanide ISA 51 VG | Other | Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 100ug) |
|
| Montanide ISA 51 VG | Other | Adjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 300ug) |
|
| 3 months |