deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT00223899

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

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

Sponsor: Vical

Conditions Metastatic Melanoma
Interventions VCL-IM01 (encoding IL-2) with Electroporation
Updated 8 times since 2017 Last updated: Feb 25, 2019 Started: Jul 31, 2005 Primary completion: Jun 30, 2008 Completion: Oct 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Metastatic Melanoma and is currently completed. Vical leads this study, which shows 8 recorded versions since 2005 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotCompleted~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Mar 2019 — Jan 2021 [monthly]

    Completed PHASE1

▶ Show 3 earlier versions

  1. Jun 2018 — Mar 2019 [monthly]

    Completed PHASE1

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Jul 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Vical
Data source: Vical

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations