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Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

Trial Status: Active

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). 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. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

Inclusion Criteria

  • Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
  • Pathology report showing results of institutional MMR IHC testing. (This requirement does not apply to sites in Japan.).
  • Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.).
  • Submission of tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration.
  • In patients with measurable disease (stage III and IVA), lesions will be defined and monitored by RECIST version (v) 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) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI.
  • Patients may have received * NO prior chemotherapy for treatment of endometrial cancer OR * Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed >= 12 months prior to STEP 2 registration.
  • Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to STEP 2 registration.
  • Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to STEP 2 registration.
  • Performance status of 0, 1 or 2.
  • Platelets >= 100,000/mcl.
  • Absolute neutrophil count (ANC) >= 1,500/mcl.
  • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN).
  • Total serum bilirubin level =< 1.5 x upper limit of normal (ULN) (patients with known Gilbert’s disease who have bilirubin level =< 3 x ULN may be enrolled).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN.
  • Thyroid stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy).
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 2 registration are eligible for this trial.
  • For patients of child bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
  • Administration of study drugs (pembrolizumab, paclitaxel, carboplatin) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from at least 14 days prior to Step 2 registration (for oral contraceptives), during treatment, and for 120 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they are either: * Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR * Have a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to Step 2 registration; OR * Have a congenital or acquired condition that prevents childbearing.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.

Exclusion Criteria

  • Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
  • Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab and/or its excipients.
  • Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to Step 2 registration.
  • Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Step 2 registration. * Patients who have received steroids as CT scan contrast premedication may be enrolled. * The use of inhaled or topical corticosteroids is allowed. * The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. * The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to Step 2 registration and remain clinically stable.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is 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 (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
  • Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, 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 who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Pregnant or lactating patients.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Alaska

Anchorage
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

California

Baldwin Park
Kaiser Permanente-Baldwin Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Bellflower
Kaiser Permanente-Bellflower
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Harbor City
Kaiser Permanente - Harbor City
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Irvine
Kaiser Permanente-Irvine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-822-5354
Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-798-0719
Mountain View
Palo Alto Medical Foundation-Gynecologic Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Orange
Saint Joseph Hospital - Orange
Status: ACTIVE
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839
Riverside
Kaiser Permanente-Riverside
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Sacramento
Mercy Cancer Center - Sacramento
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-556-3301
San Diego
Kaiser Permanente-San Diego Zion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Naval Medical Center -San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 619-532-8712
San Marcos
Kaiser Permanente-San Marcos
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Walnut Creek
John Muir Medical Center-Walnut Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 925-941-4246

Colorado

Colorado Springs
Memorial Hospital North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-364-6700
Penrose-Saint Francis Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
UCHealth Memorial Hospital Central
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294
Poudre Valley Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
UCHealth Greeley Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294
Loveland
Medical Center of the Rockies
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 970-203-7083

Connecticut

Danbury
Danbury Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-739-8074
Guilford
Smilow Cancer Hospital Care Center - Guiford
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Hartford
Hartford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 860-545-5363
New Britain
The Hospital of Central Connecticut
Status: ACTIVE
Contact: Site Public Contact
Phone: 860-224-5660
New Haven
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Norwalk
Norwalk Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-852-2996
Stamford
Stamford Hospital / Bennett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-323-8944
Waterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
Waterford
Smilow Cancer Hospital Care Center - Waterford
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702

District of Columbia

Washington
MedStar Washington Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-877-8839

Georgia

Atlanta
Northside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-303-3355
Austell
WellStar Cobb Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 470-793-4071
Marietta
WellStar Health System Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 470-793-4071
Wellstar Kennestone Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 470-793-4071
Newnan
CTCA at Southeastern Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 770-400-6629
Roswell
WellStar North Fulton Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 470-793-4071
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Memorial Health University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-350-7887
Smyrna
WellStar Vinings Health Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 470-793-4071

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Alphonsus Medical Center-Nampa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Orland Park
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Springfield
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360

Indiana

Indianapolis
Franciscan Health Indianapolis
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-528-7060
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Mooresville
Franciscan Health Mooresville
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-834-3603

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-237-1225

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671

Kentucky

Edgewood
Saint Elizabeth Medical Center South
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-301-4725

Louisiana

Baton Rouge
Woman's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353

Maine

Augusta
Harold Alfond Center for Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-626-4855
Belfast
Waldo County General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-338-2500
Rockport
Penobscot Bay Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-396-8670
Scarborough
Maine Medical Center- Scarborough Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8090

Maryland

Annapolis
Anne Arundel Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 443-481-1320
Baltimore
Greater Baltimore Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-849-3706
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804
University of Maryland / Greenebaum Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-888-8823
Bethesda
Walter Reed National Military Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 301-319-2100
Easton
University of Maryland Shore Medical Center at Easton
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-822-1000

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 781-744-3421
Lowell
Lowell General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 978-788-7084
Springfield
Baystate Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 413-794-3565
Winchester
Winchester Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Worcester
UMass Memorial Medical Center - Memorial Division
Status: ACTIVE
Contact: Site Public Contact
Phone: 508-856-6265

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Genesee Hematology Oncology PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Genesys Hurley Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Grand Rapids
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Duluth
Essentia Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Kansas City
Saint Luke's Hospital of Kansas City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
Mercy Hospital Springfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663

Nebraska

Grand Island
CHI Health Saint Francis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Livingston
Saint Barnabas Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 973-322-2934
Long Branch
Monmouth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-923-6564
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-7356
Paramus
The Valley Hospital-Luckow Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Ridgewood
Neurosurgeons of New Jersey-Ridgewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Somerville
Robert Wood Johnson University Hospital Somerset
Status: ACTIVE
Contact: Site Public Contact
Phone: 908-685-2481
Wayne
Valley Medical Group - Wayne Multispecialty Practice
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 201-389-0195
Westwood
Valley Health System-Hematology / Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923

New Mexico

Albuquerque
Southwest Gynecologic Oncology Associates Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-272-0530
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-379-6866
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-780-3677
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Lake Success
Northwell Health / Center for Advanced Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-734-8896
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-862-2215
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Hendersonville
Margaret R Pardee Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 828-696-4716
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Akron
Summa Health System - Akron Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Canton
Aultman Health Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-363-7274
Cincinnati
Good Samaritan Hospital - Cincinnati
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
University of Cincinnati / Barrett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-558-4553
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
MetroHealth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-778-8526
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
West Chester
University Pointe
Status: ACTIVE
Contact: Site Public Contact

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Ontario
Saint Alphonsus Medical Center-Ontario
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-220-4937
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Tualatin
Legacy Meridian Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-1742

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Danville
Geisinger Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Jefferson Hills
Jefferson Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-359-3043
Monroeville
Forbes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-858-7746
Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-955-6084
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073
West Penn Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-578-5000
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-481-2402

Puerto Rico

San Juan
Centro Comprensivo de Cancer de UPR
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294

Rhode Island

Providence
Women and Infants Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-274-1122

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Faris
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213

South Dakota

Rapid City
Rapid City Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-716-3982
Sioux Falls
Avera Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-322-3095
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-798-1354
Ben Taub General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-873-2000
Houston Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-790-2700
Methodist Willowbrook Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Sugar Land
Houston Methodist Sugar Land Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 281-242-2873

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100
University of Utah Sugarhouse Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Burlington
University of Vermont Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 434-243-6303
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-628-1914

Washington

Seattle
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Vancouver
Legacy Salmon Creek Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Charleston
West Virginia University Charleston Division
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-388-9944
Morgantown
Monongalia Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-598-6560
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Germantown
Aurora Health Care Germantown Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Grafton
Aurora Cancer Care-Grafton
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Kenosha
Aurora Cancer Care-Kenosha South
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-622-8922
Marinette
Aurora Bay Area Medical Group-Marinette
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Milwaukee
Aurora Cancer Care-Milwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Racine
Aurora Cancer Care-Racine
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Summit
Aurora Medical Center in Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
West Allis
Aurora West Allis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304

New Brunswick

Moncton
The Moncton Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 506-857-5267

Ontario

Barrie
Royal Victoria Regional Health Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 705-739-5661
Kingston
Kingston Health Sciences Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 613-549-6666
London
London Regional Cancer Program
Status: ACTIVE
Contact: Site Public Contact
Phone: 519-685-8600
Sudbury
Health Sciences North
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-522-6237ext2401

Quebec

Laval
Hopital de la Cite-de-la-Sante
Status: ACTIVE
Contact: Site Public Contact
Phone: 450-975-5359
Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-890-8000ext12725

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of pembrolizumab (MK-3475) in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer.

SECONDARY OBJECTIVES:

I. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm.

II. To evaluate blinded independent central review (BICR) assessed or investigator assessed objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by treatment arm and by mismatch repair (MMR) status in patients who enter the study with measurable disease.

III. To evaluate BICR assessed or investigator assessed duration of response (DOR) by treatment arm and by MMR status in patients who enter the study with measurable disease.

IV. To evaluate the effect of pembrolizumab on overall survival (OS) in patients with mismatch repair protein proficient (pMMR) or mismatch repair deficiency (dMMR).

V. To determine whether the addition of pembrolizumab (MK-3475) to standard combination chemotherapy is associated with improved patient reported physical function as measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-physical function scale (short form), quality of life as measured with the Functional Assessment of Cancer Therapy (FACT) - Endometrial Trial Outcome Index (En TOI) and worsened fatigue as measured with the PROMIS-Fatigue scale (short form) in the pMMR patients.

VI. To determine concordance between institutional MMR immunohistochemistry (IHC) testing and centralized MMR IHC.

EXPLORATORY OBJECTIVES:

I. To explore the correlation between patient-reported physical function as measured with the PROMIS-physical function scale (short form) and quality of life as measure with the FACT-En TOI.

II. To explore whether the addition of pembrolizumab (MK-3475) to standard combination chemotherapy is associated with self-reported neurotoxicity as measured with the FACT/Gynecologic Oncology Group Neurotoxicity (GOG-Ntx) subscale (short) and the extent to which patients differ on their self-reported bother from side effects of cancer therapy in the pMMR patients.

III. To evaluate the efficacy of pembrolizumab (MK-3475) in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer by PD-L1 IHC (positive versus [vs] negative).

IV. To assess the association between PD-L1 IHC (positive vs negative) and mismatch repair status (pMMR and dMMR).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

COMBINATION PHASE: Patients receive placebo intravenously (IV) over 30 minutes on day 1, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or partial response (PR) who still have measurable disease may continue treatment for up to a total 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.

ARM II:

COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.

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

Trial Phase Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Ramez Nassef Eskander

  • Primary ID NRG-GY018
  • Secondary IDs NCI-2019-02186
  • Clinicaltrials.gov ID NCT03914612