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Metastatic Melanoma or Epithelial Cancer - Healing Genes
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Metastatic Melanoma or Epithelial Cancer

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Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer

A Phase I/II Trial to Evaluate the Safety and Immunogenicity of a Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer


Phase 1 / 2

DESCRIPTION:

Doctors at the National Institutes of Health are recruiting patients with metastatic melanoma or epithelial cancer to trial a messenger RNA vaccine, essentially sending instructions into tumor cells to produce antigens that cause tumor-infiltrating lymphocytes, or TILs to attack the tumor. The trial vaccine will be customized to match the patient’s tumor.

Participants will receive an intramuscular injection of the mRNA vaccine every 2 weeks for up to 8 weeks. They may receive a second course of vaccines if the study doctor determines it is needed. Participants will have follow-up visits approximately 2 weeks after their final vaccine, then 1 month later, then every 1-2 months for the first year, and then once a year for up to 5 years.


PATIENT MUST:

  • Be 18 to 70 years of age
  • Have a diagnosis of metastatic melanoma, gastrointestinal, or genitourinary cancer with at least one lesion that is resectable, with confirmation by NIH labs
  • Meet criteria for any prior treatments or surgical operability
  • Be HIV-negative

THE STUDY INVOLVES:

  1. Prescreening at the study site to confirm eligibility of the patient to participate.
  2. Apheresis, or collection of the patient’s white blood cells, will be conducted at the study site.
  3. No treatment while the mRNA vaccines are prepared.
  4. Intramuscular injections injection of the mRNA vaccine every 2 weeks for up to 8 weeks.
  5. Participants will have follow-up visits approximately 2 weeks after their final vaccine, then 1 month later, then every 1-2 months for the first year, and then once a year for up to 5 years.

LOCATIONS & CONTACTS:
Trials will take place at the National Institutes of Health Clinical Center in Bethesda, MD. Map.

Contact:
Ellen Bodurian  |  (866) 820-4505  |  [email protected]
 
SPONSORS
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/study/NCT03480152

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