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Also known as 2mg INO-5150 and electroporation device CELLECTRA®-5P
INO-5150 and electroporation device CELLECTRA-5P · 1 trial · 1 indication
1. Incidence of adverse events (all, severe, \[NCI CTCAE v4.03\] and serious) classified by system organ class (SOC), preferred term, severity, and relationship to study medication and schedule 2. Injection site reactions 3. Changes in safety laboratory parameters .
Antigen specific cellular immune responses
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | 2mg INO-5150 and electroporation device CELLECTRA®-5P |
| Arm B | EXPERIMENTAL | 8.5mg INO-5150 and electroporation device CELLECTRA®-5P |
| Arm C | EXPERIMENTAL | 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P |
| Arm D | EXPERIMENTAL | 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P |
| Name | Type | Description |
|---|---|---|
| 2mg INO-5150 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P |
| 8.5mg INO-5150 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P |
| 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P |
| 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P | BIOLOGICAL | 8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P |
| Electroporation using CELLECTRA®-5P | DEVICE | Electroporation device CELLECTRA®-5P |
Inclusion Criteria: 1. Men aged 18 to 90 years with a histologic diagnosis of prostate cancer; 2. c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as: * After definitive surgery, e.g. * After radical prostatectomy, two PSA measurements of ...
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