Last updated on July 2019

Pembrolizumab and Epacadostat in Treating Participants With Recurrent Persistent or Progressive Ovarian Clear Cell Carcinoma


Brief description of study

This phase II trial studies how well pembrolizumab and epacadostat work in treating participants with ovarian clear cell carcinoma that has come back, remains despite treatment, or is growing, spreading, or getting worse. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better in treating participants with ovarian clear cell carcinoma.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess the objective tumor response (proportion of objective response by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) of the combination of pembrolizumab (MK-3475 [pembrolizumab]) and epacadostat in patients with recurrent or persistent clear cell carcinoma of the ovary.

SECONDARY OBJECTIVES:

I. To determine the nature and degree of toxicity of MK-3475 (pembrolizumab) + epacadostat as assessed by Common Terminology Criteria for Adverse Events (CTCAE) in patients with recurrent or persistent clear cell carcinoma of the ovary.

II. To estimate the progression-free survival (PFS) and overall survival (OS) in patients treated with combination of MK-3475 (pembrolizumab) and epacadostat.

EXPLORATORY TRANSLATIONAL OBJECTIVES:

I. Determine whether the ratio of plasma tryptophan to kynurenine (T:K) correlates with response to MK-3475 (pembrolizumab) + epacadostat, by evaluating plasma T:K pre-treatment, during treatment, and at disease progression.

II. Determine whether the presence of PD-L1, IDO-1, tumor-infiltrating regulatory T cells (Tregs), CD8 tumor-infiltrating lymphocytes (TILs), and human leukocyte antigen (HLA) class I in the tumor microenvironment at baseline correlates with objective response to MK-3475 (pembrolizumab) + epacadostat.

III. Determine whether soluble PD-L1 (sPD-L1) levels in plasma are correlated with response to MK-3475 (pembrolizumab) + epacadostat, by evaluating sPD-L1 concentrations pre-treatment, during treatment, and at disease progression.

OUTLINE

Participants receive epacadostat orally (PO) twice daily (BID) and pembrolizumab intravenously (IV) over 30 minutes once every 3 weeks (Q3W). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter.

Clinical Study Identifier: NCT03602586

Recruitment Status: Closed


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