Last updated on March 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

Contact Investigators or Research Sites near you

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Cleveland Clinic Foundation

Cleveland, OH United States
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Hillcrest Hospital Cancer Center

Mayfield Heights, OH United States
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Kootenai Medical Center

Coeur d'Alene, ID United States
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Kootenai Cancer Center

Post Falls, ID United States
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Kootenai Cancer Clinic

Sandpoint, ID United States
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Iowa Methodist Medical Center

Des Moines, IA United States
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Broadlawns Medical Center

Des Moines, IA United States
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Iowa Lutheran Hospital

Des Moines, IA United States
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Trinity Regional Medical Center

Fort Dodge, IA United States
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Methodist West Hospital

West Des Moines, IA United States
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Bozeman Deaconess Hospital

Bozeman, MT United States
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Great Falls Clinic

Great Falls, MT United States
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Community Medical Hospital

Missoula, MT United States
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Women and Infants Hospital

Providence, RI United States
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University of Virginia Cancer Center

Charlottesville, VA United States
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Billings Clinic-Cody

Cody, WY United States
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Welch Cancer Center

Sheridan, WY United States
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Adena Regional Medical Center

Chillicothe, OH United States
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Mount Carmel East Hospital

Columbus, OH United States
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Riverside Methodist Hospital

Columbus, OH United States
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Grant Medical Center

Columbus, OH United States
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Doctors Hospital

Columbus, OH United States
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Delaware Radiation Oncology

Delaware, OH United States
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Grady Memorial Hospital

Delaware, OH United States
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Fairfield Medical Center

Lancaster, OH United States
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OhioHealth Mansfield Hospital

Mansfield, OH United States
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Marietta Memorial Hospital

Marietta, OH United States
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Knox Community Hospital

Mount Vernon, OH United States
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Licking Memorial Hospital

Newark, OH United States
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Newark Radiation Oncology

Newark, OH United States
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Southern Ohio Medical Center

Portsmouth, OH United States
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Saint Ann's Hospital

Westerville, OH United States
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Fairview Ridges Hospital

Burnsville, MN United States
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Mercy Hospital

Coon Rapids, MN United States
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Unity Hospital

Fridley, MN United States
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Abbott-Northwestern Hospital

Minneapolis, MN United States
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Hennepin County Medical Center

Minneapolis, MN United States
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Health Partners Inc

Minneapolis, MN United States
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Monticello Cancer Center

Monticello, MN United States
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New Ulm Medical Center

New Ulm, MN United States
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Mayo Clinic

Rochester, MN United States
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Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, MN United States
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Regions Hospital

Saint Paul, MN United States
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United Hospital

Saint Paul, MN United States
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Lakeview Hospital

Stillwater, MN United States
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Ridgeview Medical Center

Waconia, MN United States
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Rice Memorial Hospital

Willmar, MN United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Cox Cancer Center Branson

Branson, MO United States
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Freeman Health System

Joplin, MO United States
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Mercy Hospital Joplin

Joplin, MO United States
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Heartland Regional Medical Center

Saint Joseph, MO United States
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Mercy Hospital Saint Louis

Saint Louis, MO United States
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Mercy Hospital Springfield

Springfield, MO United States
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CoxHealth South Hospital

Springfield, MO United States
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Mercy Hospital Washington

Washington, MO United States
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Mercy Hospital Oklahoma City

Oklahoma City, OK United States
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Alaska Women's Cancer Care

Anchorage, AK United States
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Anchorage Oncology Centre

Anchorage, AK United States
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Katmai Oncology Group

Anchorage, AK United States
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Bay Area Hospital

Coos Bay, OR United States
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Mercy Hospital South

Saint Louis, MO United States
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Recruitment Status: Open


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