Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer

March 22, 2024 updated by: National Cancer Institute (NCI)

A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary

This phase II trial studies how well pembrolizumab and epacadostat work in treating patients with ovarian clear cell carcinoma that has come back (recurrent), remains despite treatment (persistent), or is growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and 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 compared to usual treatment (surgery, radiation, or cytotoxic chemotherapy) in treating patients with ovarian clear cell carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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:

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

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - Aguadilla, Puerto Rico, 00603
    - Advance Oncology Center
  - Arecibo, Puerto Rico, 00614
    - Doctor's Cancer Center-Arecibo
  - Bayamon, Puerto Rico, 00959-5060
    - Cancer Center-Metro Medical Center Bayamon
  - Bayamon, Puerto Rico, 00961
    - Hematologia Oncologia San Pablo
  - Caguas, Puerto Rico, 00726
    - HIMA San Pablo Oncologic Hospital
  - Manati, Puerto Rico, 00674
    - Doctors Cancer Center
  - Ponce, Puerto Rico, 00716
    - Instituto Oncologia Moderna Ponce
  - San Juan, Puerto Rico, 00917
    - San Juan Community Oncology Group
  - San Juan, Puerto Rico, 00927
    - Centro Comprensivo de Cancer de UPR
  - San Juan, Puerto Rico, 00936
    - San Juan City Hospital
  - San Juan, Puerto Rico, 00920
    - Primary Care Physician Group
  - Santa Isabel, Puerto Rico, 00757
    - Centro de Hematologia y Oncologia del Sur
United States
- Alaska
  - Anchorage, Alaska, United States, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, United States, 99504
    - Anchorage Radiation Therapy Center
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80209
    - The Women's Imaging Center
  - Denver, Colorado, United States, 80206
    - National Jewish Health-Main Campus
  - Denver, Colorado, United States, 80220
    - Western Surgical Care
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Englewood, Colorado, United States, 80113
    - Mountain Blue Cancer Care Center - Swedish
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Golden, Colorado, United States, 80401
    - National Jewish Health-Western Hematology Oncology
  - Grand Junction, Colorado, United States, 81501
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lafayette, Colorado, United States, 80026
    - Good Samaritan Medical Center
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
  - Thornton, Colorado, United States, 80260
    - National Jewish Health-Northern Hematology Oncology
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Florida
  - Coral Gables, Florida, United States, 33146
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Miami, Florida, United States, 33176
    - UM Sylvester Comprehensive Cancer Center at Kendall
  - Pensacola, Florida, United States, 32504
    - Sacred Heart Hospital
  - Plantation, Florida, United States, 33324
    - UM Sylvester Comprehensive Cancer Center at Plantation
- Georgia
  - Augusta, Georgia, United States, 30912
    - Augusta University Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Queen's Cancer Center - Pearlridge
  - 'Aiea, Hawaii, United States, 96701
    - The Cancer Center of Hawaii-Pali Momi
  - 'Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Westridge
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Island Urology
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Emmett, Idaho, United States, 83617
    - Walter Knox Memorial Hospital
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Cancer Institute - Nampa
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Danville, Illinois, United States, 61832
    - Carle at The Riverfront
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Hinsdale, Illinois, United States, 60521
    - Sudarshan K Sharma MD Limited-Gynecologic Oncology
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - New Lenox, Illinois, United States, 60451
    - UC Comprehensive Cancer Center at Silver Cross
  - Orland Park, Illinois, United States, 60462
    - University of Chicago Medicine-Orland Park
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Ascension Saint Vincent Indianapolis Hospital
- Iowa
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Council Bluffs, Iowa, United States, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mission Cancer and Blood - Laurel
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Fort Dodge, Iowa, United States, 50501
    - Trinity Regional Medical Center
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Coffeyville, Kansas, United States, 67337
    - Coffeyville Regional Medical Center
  - Hays, Kansas, United States, 67601
    - HaysMed University of Kansas Health System
  - Olathe, Kansas, United States, 66061
    - Olathe Health Cancer Center
  - Pittsburg, Kansas, United States, 66762
    - Ascension Via Christi - Pittsburg
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - University of Kansas Hospital-Westwood Cancer Center
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Flaget Memorial Hospital
  - Corbin, Kentucky, United States, 40701
    - Commonwealth Cancer Center-Corbin
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - London, Kentucky, United States, 40741
    - Saint Joseph London
  - Louisville, Kentucky, United States, 40202
    - Jewish Hospital
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, United States, 40215
    - Saints Mary and Elizabeth Hospital
  - Shepherdsville, Kentucky, United States, 40165
    - Jewish Hospital Medical Center South
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
- Michigan
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Port Huron, Michigan, United States, 48060
    - Huron Medical Center PC
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Saint Louis Cancer and Breast Institute-Ballwin
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Centers
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Saint Vincent Frontier Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - CHI Health Saint Francis
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Kearney, Nebraska, United States, 68845
    - Heartland Hematology and Oncology
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68122
    - Hematology and Oncology Consultants PC
  - Papillion, Nebraska, United States, 68046
    - Midlands Community Hospital
- Nevada
  - Carson City, Nevada, United States, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - OptumCare Cancer Care at Seven Hills
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - GenesisCare USA - Henderson
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89109
    - GenesisCare USA - Las Vegas
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89106
    - Women's Cancer Center of Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - GenesisCare USA - Vegas Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89148
    - GenesisCare USA - Fort Apache
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, United States, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, United States, 89103
    - Hope Cancer Care of Nevada
  - Las Vegas, Nevada, United States, 89169
    - University Cancer Center
  - Pahrump, Nevada, United States, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87106
    - Southwest Gynecologic Oncology Associates Inc
  - Rio Rancho, New Mexico, United States, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
- New York
  - White Plains, New York, United States, 10601
    - Dickstein Cancer Treatment Center
- Ohio
  - Beachwood, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Chardon, Ohio, United States, 44024
    - Geauga Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, United States, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mentor, Ohio, United States, 44060
    - UH Seidman Cancer Center at Lake Health Mentor Campus
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Ravenna, Ohio, United States, 44266
    - University Hospitals Portage Medical Center
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Toledo, Ohio, United States, 43606
    - ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  - Wadsworth, Ohio, United States, 44281
    - University Hospitals Sharon Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
  - Tulsa, Oklahoma, United States, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
- Oregon
  - Baker City, Oregon, United States, 97814
    - Saint Alphonsus Medical Center-Baker City
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Medical Center-Ontario
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Redmond, Oregon, United States, 97756
    - Saint Charles Health System-Redmond
- Pennsylvania
  - Willow Grove, Pennsylvania, United States, 19090
    - Asplundh Cancer Pavilion
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women and Infants Hospital
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Memorial Hospital
  - Hixson, Tennessee, United States, 37343
    - Pulmonary Medicine Center of Chattanooga-Hixson
  - Ooltewah, Tennessee, United States, 37363
    - Memorial GYN Plus
- Texas
  - Bryan, Texas, United States, 77802
    - Saint Joseph Regional Cancer Center
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
- Washington
  - Aberdeen, Washington, United States, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Bremerton, Washington, United States, 98310
    - Harrison Medical Center
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute-Edmonds
  - Enumclaw, Washington, United States, 98022
    - Saint Elizabeth Hospital
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, United States, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, United States, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Sedro-Woolley, Washington, United States, 98284
    - PeaceHealth United General Medical Center
  - Shelton, Washington, United States, 98584
    - Providence Regional Cancer System-Shelton
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98405
    - Franciscan Research Center-Northwest Medical Plaza
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, United States, 98597
    - Providence Regional Cancer System-Yelm
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Mukwonago, Wisconsin, United States, 53149
    - ProHealth D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - UW Cancer Center at ProHealth Care
  - Waukesha, Wisconsin, United States, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
- Wyoming
  - Cheyenne, Wyoming, United States, 82001
    - Cheyenne Regional Medical Center-West
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology. Recurrence should be biopsy proven as per standard of care unless the tumor is located in an area deemed unsafe to biopsy. Histologic confirmation of the original primary tumor is required via the pathology report. The percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report. If slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology, as long as tumor is located in an area deemed safe to biopsy. The percentage of clear cell involvement must be documented in the pathology report or in an addendum to the original report
All patents must have measurable disease, and at least one "target lesion" to be used to assess response as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 28 days prior to registration
- Imaging of target lesions within 28 days prior to registration
- Further protocol-specific assessments
  - Recovery from adverse effects of recent surgery, radiotherapy or chemotherapy (residual grade 1 toxicity is considered recovered)
  - Any other prior therapy directed at the malignant tumor including chemotherapy, and biologic/targeted agents must be discontinued at least 4 weeks prior to registration. Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to registration
  - Any prior radiation therapy must be completed at least 4 weeks prior to registration, and progression must be outside the radiation field
  - At least 4 weeks must have elapsed since any major surgery prior to registration
The trial is open only to women with recurrent or progressive clear cell carcinoma of the ovary
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 28 days prior to registration
Patients must have had one prior platinum-based chemotherapy for management of primary disease. Patients are allowed to receive, but are not required to receive, up to two additional cytotoxic regimens for management of recurrent or persistent disease
Absolute neutrophil count (ANC) >= 1,500/ul (within 14 days prior to registration)
Platelets >= 100,000/ul (within 14 days prior to registration)
Hemoglobin (Hgb) >= 8.0 g/dL within 14 days prior to registration (Note: the use of transfusion of other intervention to achieve a Hgb >= 8.0 g/dL is acceptable)
Creatinine =< 1.5 x institutional upper limit of normal (ULN) or creatinine clearance (CrCl) >= 60 mL/min using Cockcroft-Gault formula (within 14 days prior to registration)
Bilirubin =< 2.5 x ULN (within 14 days prior to registration)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (within 14 days prior to registration)
Normal thyroid function testing (thyroid-stimulating hormone [TSH]) (within 14 days prior to registration)
Negative pregnancy test in women of childbearing potential
Women of childbearing potential who are sexually active should be willing and able to use medically acceptable forms of contraception for the course of the study through 120 days after the last dose of MK-3475 (pembrolizumab). Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile, who have had a hysterectomy and/or bilateral oophorectomy) do not require contraception
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria:

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Patients who have had prior therapy with MK-3475 (pembrolizumab) or epacadostat or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways
History of severe hypersensitivity reaction to any monoclonal antibody
Patients with active auto-immune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure and unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, and/or epidural disease, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment. Those with brain metastases are permitted as long as they have been treated with brain radiation therapy and have been documented stability 4 weeks following completion of brain radiation therapy
In order for patients with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be eligible, they must be on a stable highly active antiretroviral therapy (HAART) regimen with no drug-drug interaction with UGT1A9, have CD4+ counts > 350, with no detectable viral load on quantitative polymerase chain reaction (PCR), and no opportunistic infection
Patients with treated hepatitis viral infections (hepatitis B and C) are eligible if they have completed definitive treatment at least 6 months prior, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
Therapy with monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitor (SSRIs) within the last 4 weeks or history of serotonin syndrome. Concomitant use of monoamine oxidase inhibitors or SSRIs with epacadostat (INCB024360) is prohibited
Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, abdominal/pelvic fistula, gastrointestinal perforation, gastrointestinal (GI) obstruction and/or who require parenteral hydration and/or nutrition
Epacadostat (INCB024360) is a substrate of CYP3A4, CYP1A2, CYP2C19, UGT1A9, P-gp, and BCRP. Use caution when administered with strong inhibitors/inducers of these isoenzymes and transporter proteins. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference
History or presence of an abnormal electrocardiography (ECG) that, in the investigator's opinion, is clinically meaningful. Screening QTc interval > 480 milliseconds is excluded (corrected by Fridericia). In the event that a single QTc is > 480 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 480 milliseconds. For subjects with an intraventricular conduction delay (QRS interval > 120 msec), the JTc interval may be used in place of the QTc with sponsor approval. The JTc must be < 340 milliseconds if JTc is used in place of QTc. Subjects with left bundle branch block are excluded
Patients who are pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (epacadostat, pembrolizumab) Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Biological: Pembrolizumab Given IV Other Names: Keytruda MK-3475 Lambrolizumab SCH 900475 BCD-201 Pembrolizumab Biosimilar BCD-201 Drug: Epacadostat Given PO Other Names: INCB024360 INCB 024360

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete or Partial Objective Tumor Response Time Frame: Within 7 months of study entry	Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=20% decrease in the sum of the longest diameter of target lesions and a 5 mm absolute increase; Overall Response (OR) = CR + PR.	Within 7 months of study entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events of Grade 3 or Higher Time Frame: Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months.	Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5. Number of participants with an adverse event of grade 3 or higher.	Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months.
Progression-free Survival (PFS) Time Frame: Radiographic tumor assessments were completed 12 weeks after the start of treatment, then every 6 weeks for 49 weeks, followed by every 12 weeks until disease progression or treatment discontinuation. The median follow-up time was 4.8 months.	Disease progression will be defined using RECIST v. 1.1 criteria. The distributions of PFS will be estimated and graphed using the Kaplan-Meier product limit method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=20% decrease in the sum of the longest diameter of target lesions and a 5 mm absolute increase; Overall Response (OR) = CR + PR." Progression-free survival (PFS) is defined as the duration of time from the start of study treatment to time of progression or death, whichever occurs first.	Radiographic tumor assessments were completed 12 weeks after the start of treatment, then every 6 weeks for 49 weeks, followed by every 12 weeks until disease progression or treatment discontinuation. The median follow-up time was 4.8 months.
Overall Survival (OS) Time Frame: Overall survival (OS) is defined as the duration of time from the start of study treatment to time of death or the date of last contact. The median follow-up time for OS was 34.9 months.	Assessment of deaths starting from the time of enrollment.	Overall survival (OS) is defined as the duration of time from the start of study treatment to time of death or the date of last contact. The median follow-up time for OS was 34.9 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of Plasma Tryptophan to Kynurenine (T:K) Time Frame: Up to 5 years	Will determine whether the ratio of plasma T:K correlates with response to MK-3475 (pembrolizumab) and epacadostat, by evaluating plasma T:K pre-treatment, during treatment, and at disease progression. Pre-treatment levels of T:K ratio in plasma will be assessed for association with radiographic response to MK-3475 (pembrolizumab) and epacadostat. Changes between pre-treatment and post-cycle 1 and changes between post-cycle 1 and disease progression for T:K ratio will be evaluated with paired Student's T tests.	Up to 5 years
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 Time Frame: Up to 5 years	Will determine whether the presence of PD-L1, IDO-1, Tregs, CD8 TILs, and HLA class I in the tumor microenvironment at baseline correlates with objective response to MK-3475 (pembrolizumab) + epacadostat. Baseline presence of PD-L1, IDO-1, Tregs, TILs, and HLA class I in the tumor microenvironment will also be assessed for correlation with radiographic response to MK-3475 (pembrolizumab) and epacadostat. Will consider logistic regression models for these analyses of continuous biomarkers, if appropriate given the number of responses and if exact tests of response for categorized levels of the biomarkers.	Up to 5 years
Soluble PD-L1 (sPD-L1) Levels in Plasma Time Frame: Up to 5 years	Will determine whether 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. Pre-treatment levels of sPD-L1 in plasma will be assessed for association with radiographic response to MK-3475 (pembrolizumab) and epacadostat. Changes between pre-treatment and post-cycle 1 and changes between post-cycle 1 and disease progression for sPD-L1 will be evaluated with paired Student's T tests.	Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

NRG Oncology

Investigators

Principal Investigator: Lilian T Gien, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2018

Primary Completion (Actual)

February 1, 2021

Study Completion (Estimated)

September 22, 2024

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2018-01561 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180868 (U.S. NIH Grant/Contract)
NRG-GY016 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Additional Relevant MeSH Terms

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Pembrolizumab

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CROs by country

CROs in Papua New Guinea

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Drug Interventions

Dietary Supplements

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