A Phase 1 interventional study of VCL-IM01 (encoding IL-2) with Electroporation in Metastatic Melanoma, sponsored by Vical. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Vical · Phase 1, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 26 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Vical is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria - Key criteria include:
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).
Genetic: VCL-IM01 (encoding IL-2) with Electroporation
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).
Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
Time frame: After all subjects have been enrolled
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.
Time frame: After all subjects have been enrolled
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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