PISCES : A Multicenter Phase 2, Open-Label Trial of Intratumoral pIL-12 Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This Phase II trial is evaluating an intratumoral therapy (within a tumor) and electroporation (a microbiology technique that applies an electric field to cells in the body) in combination with an immunotherapy agent (Pembrolizumab) in patients with advanced stage II/IV melanoma.
 

This trial is treating patients with Melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Multicenter Phase 2, Open-Label Trial of Intratumoral pIL-12 Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment

Commercial Sponsor

OncoSec Medical Incorporated

Summary

The study will be comprised of a Core study (24 weeks), an Extension Phase and a long-term safety follow-up. Core study: Eligible patients will be treated with intratumoral pIL-12-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for 24 weeks. As many accessible lesions, may be treated, as deemed feasible by the treating physician . Extension phase: Patients who completed 24 weeks of treatment (Core study) with the investigators discretion, will enter an Extension phase and continue to receive the combined treatment of intratumoral pIL-12-EP and pembrolizumab for up to 35 cycles of pembrolizumab from baseline (approximately 2 years) or until subsequent disease progression.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Eleanor Edwards
El.Edwards@alfred.org.au
03 9076 2297

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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