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To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.
Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s).
Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks.
Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCL-IM01 (encoding IL-2) with Electroporation | Genetic | IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma | After all subjects have been enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate, duration of response, treated tumor response rate, assessment of injected tumor(s) for induration, inflammation, and erythema, and serum levels of IL-2. | After all subjects have been enrolled |
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Inclusion Criteria - Key criteria include:
Exclusion Criteria - Key criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Dmitri D. Kharkevitch, MD, PhD | Vical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Location #2 | Mobile | Alabama | 36606 | United States | ||
| Location #3 |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
| Denver |
| Colorado |
| 80045 |
| United States |
| Location #1 | Chicago | Illinois | 60068 | United States |
| Location #4 | Montclair | New Jersey | 07042 | United States |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |