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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_671 |
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Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.
The optional followup period for this study is 1 year after the last vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | V930 |
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| 2 | Experimental | V932 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V930 | Biological | V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of V930/V932 followed by EP in cancer patients | Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay | Week 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497415 | Derived | Diaz CM, Chiappori A, Aurisicchio L, Bagchi A, Clark J, Dubey S, Fridman A, Fabregas JC, Marshall J, Scarselli E, La Monica N, Ciliberto G, Montero AJ. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J Transl Med. 2013 Mar 8;11:62. doi: 10.1186/1479-5876-11-62. |
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| V932 | Biological | V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection). |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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