A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Genetic: VCL-IM01 (encoding IL-2) with Electroporation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Key criteria include: Confirmed recurrent metastatic melanoma Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment Able to carry out normal daily activities and light work without assistance Not currently receiving chemotherapy or immunotherapy Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed) Able and willing to give informed consent. Exclusion Criteria - Key criteria include: History of brain tumors (resected or stereotactically treated is allowed) History of liver tumors Subjects whose melanoma can be cured by surgery Pregnant Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Electroporation, IL-2