This trial studies the side effects and how well MDC3/8 vaccines work in treating patients with stage III-IV melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03092453.
PRIMARY OBJECTIVES:
I. To determine the immunological response based on measuring increased numbers of peptide specific T cells as calculated by the tetramer assay.
II. To assess the safety and tolerability of the mature dendritic cell vaccine (mDC3/8 vaccines).
SECONDARY OBJECTIVES:
I. To determine the clinical response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
II. To determine the time to progression.
III. To assess regulatory T cell depletion after cyclophosphamide administration.
IV. To perform exploratory biomarker analysis of accessible tumors.
V. To determine the safety and side effect profile of the dendritic cell vaccine (mDC3/8 vaccines) administered to patients given after a single dose of cyclophosphamide.
OUTLINE:
Patients receive cyclophosphamide intravenously (IV) on day -3 and mDC3/8 vaccine IV over approximately 15 minutes on day 1. Beginning 6 weeks later, patients receive 2 additional booster vaccines 6 weeks apart in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 10-28 days, 4 and 8 weeks, and approximately 30 weeks after first vaccine.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorGerald P Linette
