New Approaches,

New Hope

Melanoma is a type of skin cancer that begins in skin cells called melanocytes. As the cancer progresses, melanoma becomes more difficult to treat once it spreads beyond the skin, such as the lymphatic system (metastatic disease). Given its occurrence in young individuals, the potential years of life lost to melanoma can be higher when compared with other cancers. Although melanoma is a rare form of skin cancer, it accounts for over 75% of skin cancer deaths. The American Cancer Society estimates that approximately 87,000 new melanoma cases and 10,000 deaths from the disease will occur in the United States in 2017. Additionally, the World Health Organization estimates that approximately 132,000 new cases of melanoma are diagnosed around the world every year.

For more information about metastatic melanoma, please visit:

*These sources should be used for informational purposes only. For specific medical questions or issues, please contact a healthcare professional.

The PISCES Study:

A Multicenter Phase 2, Open‑Label Study of Intratumoral Tavokinogene Telseplasmid (TAVO, 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

STATUS
Active and recruiting participants
PATIENT GOAL
48
STUDY IDENTIFIER

Clinicaltrials.gov study identifier: NCT03132675 

TRIAL PHASE
Phase 2b Registration-Directed Open Label Clinical Trial.
INTERVENTION
ImmunoPulse® IL-12 in Combination with Pembrolizumab
ELIGIBILITY

Please refer to the guidelines below

STATUS
Active and recruiting participants
PATIENT GOAL
48
IDENTIFIER

Clinicaltrails.gov study identifier: NCT03132675 

TRIAL PHASE
Phase 2b Registration-Directed Open Label Clinical Trial.
INTERVENTION
ImmunoPulse® IL-12 (tavo) in Combination with Pembrolizumab
ELIGIBILITY

Please refer to the guidelines below

PISCES is a clinical trial of TAVO1 in combination with pembrolizumab to treat patients with stage III/IV metastatic melanoma who have failed or are failing on anti-PD- 1 therapies (like nivolumab and pembrolizumab). In previous studies, the combination of TAVO and pembrolizumab have shown a 50% best overall response rate (BORR)2 by physician assessment, in metastatic melanoma patients predicted not to respond to anti-PD- 1 therapies alone. 

ImmunoPulse® IL-12 is an investigational treatment that has not been approved by the U.S. Food and Drug Administration (FDA) for melanoma or any other disease. The ImmunoPulse® platform focuses on the delivery of DNA-based interleukin-12 (IL-12; TAVO), a naturally occurring protein with immune-stimulating functions. The treatment itself is designed to produce a controlled, localized expression of TAVO in the tumor microenvironment, which in turn, enables the immune system to target and attack
tumors throughout the body. It is believed TAVO primes the immnune system, or as an analogy, provides the “gas for the car”.

Pembrolizumab is a medication that has been approved by the FDA for the treatment of metastatic melanoma. Pembrolizumab is a type of immunotherapy that works by targeting PD-1, a signaling receptor that helps cancer cells hide from the body’s immune system. Pembrolizumab blocks the PD-1 pathway and helps the immune system target and fight cancer cells. The analogy is that it “removes the brakes” Pembrolizumab is given to patients by IV infusion.

Immunotherapies can sometimes be seen like a car - approved therapies like pembrolizumab, the anti-PD-1, takes the foot of the brake, and TAVO puts gas in the tank. It is believed that the combination will provide more effective response in the body and that will effect tumor growth.

ImmunoPulse® IL-12 is a registered trademark of OncoSec.

1IL-12 = tavokinogene telseplasmid (tavo) TAVO 
2Reference SITC 2017 

Participants will receive a study treatment called ImmunoPulse® IL-12 in combination with pembrolizumab, which may enhance the effects of the anti-PD- 1 therapy allowing the participants immune system to fight and detect cancer cells.

Participants will receive:

  • a 30-minute infusion of pembrolizumab once a every three week intravenously, and;
  • ImmunoPulse® IL-12, which injects the human gene IL-12 (tavo)1  directly into the tumor and uses a small electrical current (electroporation) to allow the IL-12 gene to readily enter the tumor, every 6 weeks, for the duration of the study.  

Tests and procedures during this study include:

  • Measurements and photographs of melanoma lesions, physical exams, and samples of blood, tissue, stool and tumor biopsies for the immune monitoring program.
  • Data analyzed from these samples will allow for a deeper understanding of how to best fight cancer in this and future clinical trials.

1IL-12 = tavokinogene telseplasmid

To qualify for this study, participants must:

  • Be at least 18 years of age
  • Have confirmed unresectable stage III/IV melanoma
  • Have at least one lesion surface accessible
  • Have not progressed with an approved checkpoint inhibitor therapy (pembrolizumab and/or nivolumab

A complete list of eligibility criteria can be found online at ClinicalTrials.gov or by contacting the study site.

For specific questions related to your eligibility for a clinical trial we encourage you to speak with your healthcare team or a study site investigator. You may access a list of participating sites below.

  • ImmunoPulse® IL-12 therapy is a gene-based (DNA) therapeutic that can force a treated tumor to produce a strong immune-activating protein which helps recruit an army of CD8+ T cells to the tumor (step 1 - this is needed for an effective anti-PD-1 therapy).
  • This primes the immune system or gives the gas needed for the immune machine
  • As a reaction to these freshly recruited CD8+ T cells, tumors increase their levels of PD-L1 (step 2 for an effective anti-PD-1 therapy), which when bound to PD-1 on the surface of a T cells, applies an “immunological brake” and diminishes its anti-cancer capability.
  • Thus, combining ImmunoPulse® IL-12 with pembrolizumab allows for each to work optimally.

This study will be conducted in the following sites across the United States and Australia.

To learn more about how to contact a study site, please email patientinfo@oncosec.com.

      To learn more about this study or to reach a study site, please contact: patientinfo@oncosec.com

      Sign up to get updates about our clinical trials and other exciting news