Recurrent Melanoma Clinical Trial
Official title:
A Phase II Pilot Trial of an Indoleamine 2,3, Dioxygenase-1 (IDO1) Inhibitor (INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients With Advanced Melanoma
This pilot phase II trial studies how well epacadostat and vaccine therapy work in treating patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from peptides and antigens may help the body build an effective immune response to kill tumor cells. Giving epacadostat with vaccine therapy may be an effective treatment for advanced melanoma.
PRIMARY OBJECTIVES:
I. To determine the extent to which a regimen of INCB024360 (epacadostat) that normalizes
serum kynurenine (Kyn)/ tryptophan (Trp) ratios alters the tumor microenvironment of
melanoma, including determining the number and character of tumor-infiltrating lymphocytes as
determined by examination of serial biopsies with immunohistochemistry (IHC) and gene
signatures.
II. To determine the extent to which continued INCB024360 treatment plus the addition of the
multipeptide melanoma vaccine, MELITAC 12.1 (MELITAC 12.1 peptide vaccine), further alters
the tumor microenvironment of melanoma, including determining the number and character of
tumor-infiltrating lymphocytes as determined by serial biopsies evaluating IHC and gene
signatures.
SECONDARY OBJECTIVES:
I. To determine whether a regimen of INCB024360 that normalizes serum Kyn/Trp ratios plus
MELITAC 12.1 vaccine changes the level or character of the vaccine-induced clusters of
differentiation (CD) 8+ and CD4+ T-cell immune responses as measured in peripheral blood, as
compared to prior published experience.
II. To evaluate the extent to which INCB024360 plus MELITAC 12.1 vaccine alters the number
and character of peripheral blood mononuclear cell (PBMC) populations, including T and
natural killer (NK) cells, as evaluated by multiparameter flow cytometry.
III. To evaluate the extent to which INCB024360 plus MELITAC 12.1 vaccine alters the PBMC
transcriptome.
IV. To assess the safety and tolerability of INCB024360 plus MELITAC 12.1 vaccine.
V. To obtain preliminary data on the tumor response rate of INCB024360 plus MELITAC 12.1
vaccine by objective response rate (ORR), time to tumor progression, and overall survival.
VI. To associate any observed changes with the expression of IDO1 protein by IHC in tumor or
tumor-infiltrating cells.
OUTLINE:
Patients receive epacadostat orally (PO) twice daily (BID) on days 1-98 and receive MELITAC
12.1 peptide vaccine intradermally (ID)/subcutaneously (SC) on days 21, 28, 35, 56, 77, and
98. Treatment with epacadostat may repeat every 98 days for up to 3 additional courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
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