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Cutaneous Melanoma - Healing Genes
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Cutaneous Melanoma

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pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma

Phase 1 Study Using a Plasmid DNA Coding for Emm55 Streptococcal Antigen in Patients With Unresectable Stage III or Stage IV Cutaneous Melanoma


Phase 1

DESCRIPTION:

  1. Lee Moffitt Cancer Center and Research Institute is recruiting participants with stage III or IV cutaneous melanoma to trial a new treatment that inserts a loop of DNA, a plasmid, into the melanoma lesion. The plasmid inserts itself into the DNA of the tumor cell and, when expressed, it alerts the immune system to attack those tumor cells.

The treatment will be injected once into as many as 3 melanoma lesions, and follow up will involve lab and physical assessments for up to a year.


PATIENT MUST:

  • Be 18 years of age or older
  • Life expectancy of >3 months.
  • Have failed, refused or been deemed not candidates for talimogene laherparepvec (IMLYGIC®)
  • Not be pregnant or breastfeeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Identification of up to 3 lesions for injection. One injection of the drug is given per lesion.
  3. Close follow up will be required for 1 month, and long-term follow up lasts 1 year.

LOCATIONS AND CONTACTS:
The study site is at the H. Lee Moffitt Cancer Center in Tampa, FL. Map.
 
Contacts:
Michael JP Lawman, PhD  |  813-875-6600 ext 101  |  [email protected]
Patricia D Lawman, PhD  |  813-875-6600 ext 102  |  [email protected]
 
SPONSOR INFORMATION:
Morphogenesis, Inc.

  1. Lee Moffitt Cancer Center and Research Institute

 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03655756

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