Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
A Phase I/IIb Study of Recombinant ALVAC(2)-NY-ESO-1 (M)/TRICOM in Combination With INCB024360 for Patients in Remission With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen
This partially randomized phase I/IIb trial studies the side effects vaccine therapy and indoleamine 2,3-dioxygenase (IDO1) inhibitor 4-amino-1,2,5-oxadizaole-3-carboximidamide (INCB024360) and to see how well they work in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in remission. Vaccines made from gene-modified virus may help the body build an effective immune response to kill tumor cells. IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy with IDO1 inhibitor INCB024360 may be an effective treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
I. To determine the safety of fixed doses of the modified canarypox vector
(ALVAC[2])-cancer/testis antigen 1B (NY-ESO-1) (M)/triad of costimulatory molecules (TRICOM)
vaccine in combination with INCB024360 (IDO1 inhibitor INCB024360). (Phase I) II. To
evaluate toxicity as defined by National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events (CTCAE) version 4.0. (Phase I) III. To determine the progression free
survival (PFS) using standard imaging response (Response Evaluation Criteria in Solid Tumors
[RECIST] 1.1) criteria. (Phase IIb)
SECONDARY OBJECTIVES:
I. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing
NY-ESO-1 specific cellular and humoral immunity in peripheral blood NY-ESO-1 specific CD8+
and CD4+ T cells.
II. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing
NY-ESO-1 specific cellular and humoral immunity in peripheral blood NY-ESO-1 specific
antibodies.
III. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing
NY-ESO-1 specific cellular and humoral immunity in peripheral blood frequency of
CD4+CD25+FOXP3+ regulatory T cells.
IV. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing
NY-ESO-1 specific cellular and humoral immunity in pharmacokinetics (PK) of IDO in relation
to T cell frequency and function in correlation with PFS.
OUTLINE: This is a Phase I study followed by a randomized Phase IIb study.
PHASE I: Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine subcutaneously (SC) on day 1
and IDO1 inhibitor INCB024360 orally (PO) twice daily (BID) on days 1-28. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
PHASE IIb: Patients are randomized to 1 of 4 arms.
ARM A: Patients receive no treatment.
ARM B: Patients receive IDO1 inhibitor INCB024360 PO BID on days 1-28.
ARM C: Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1 and IDO1 inhibitor
INCB024360 PO BID on days 1-28.
ARM D: Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1.
In all arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks; at 3, 6, and 12
months; and then annually for up to 15 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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