Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01961115
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2013-10-08
Brief Title:
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Pilot Trial of an Indoleamine 23 Dioxygenase-1 IDO1 Inhibitor INCB024360 Plus a Multipeptide Melanoma Vaccine MELITAC 121 in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 121 MELITAC 121 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 KynTrp ratios plus MELITAC 121 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 121 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 121 vaccine alters the PBMC transcriptome
IV To assess the safety and tolerability of INCB024360 plus MELITAC 121 vaccine
V To obtain preliminary data on the tumor response rate of INCB024360 plus MELITAC 121 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 121 peptide vaccine intradermally IDsubcutaneously 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
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 121 MELITAC 121 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 KynTrp ratios plus MELITAC 121 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 121 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 121 vaccine alters the PBMC transcriptome
IV To assess the safety and tolerability of INCB024360 plus MELITAC 121 vaccine
V To obtain preliminary data on the tumor response rate of INCB024360 plus MELITAC 121 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 121 peptide vaccine intradermally IDsubcutaneously 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2013-01605 | REGISTRY | None | None |
| CITN-04 | OTHER | None | None |
| CITN-04 | OTHER | None | None |
| U01CA154967 | NIH | CTEP | httpsreporternihgovquickSearchU01CA154967 |