Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
NCT ID: NCT03914612
Last Updated: 2025-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
813 participants
INTERVENTIONAL
2019-08-22
2026-09-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer
NCT04214067
Pembrolizumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT02520154
Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer
NCT03932409
Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
NCT00807768
Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
NCT02065687
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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) immunohistochemistry (IHC) 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 IHC status in patients who enter the study with measurable disease.
IV. To evaluate the effect of pembrolizumab (MK-3475) 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 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 Programmed Death Ligand 1 (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 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. 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 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm I will not receive additional placebo infusions.
ARM II:
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. 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 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo computed tomography (CT) scan throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (placebo, paclitaxel, carboplatin)
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. 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 placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan throughout the study.
On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm 1 will not receive additional placebo infusions.
Carboplatin
Given IV
Computed Tomography
Undergo CT scan
Paclitaxel
Given IV
Placebo Administration
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (pembrolizumab, paclitaxel, carboplatin)
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. 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 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan throughout the study.
Carboplatin
Given IV
Computed Tomography
Undergo CT scan
Paclitaxel
Given IV
Pembrolizumab
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carboplatin
Given IV
Computed Tomography
Undergo CT scan
Paclitaxel
Given IV
Pembrolizumab
Given IV
Placebo Administration
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pathology report showing results of institutional MMR IHC testing.
* 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, 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 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.
* Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted.
* Age \>= 18.
* 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 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. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal Free T4 level is required.
* 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 \[MK-3475\], 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 who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients; and/or a severe hypersensitivity reaction to paclitaxel and/or carboplatin.
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Cancer Trials Group
NETWORK
NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ramez N Eskander
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Community Cancer Institute
Clovis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Kaiser Permanente South Bay
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Mercy Regional Cancer Center
Redding, California, United States
Mercy Oncology Center
Redding, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Naval Medical Center -San Diego
San Diego, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
City of Hope Upland
Upland, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Memorial Hospital North
Colorado Springs, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - Bradenton Cancer Center
Bradenton, Florida, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, United States
Florida Cancer Specialists - Venice Island
Venice, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States
WellStar Health System Inc
Marietta, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
WellStar North Fulton Hospital
Roswell, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
WellStar Vinings Health Park
Smyrna, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, United States
Northwest Oncology LLC
Dyer, Indiana, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, United States
Saint Mary Medical Center
Hobart, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Community Cancer Center East
Indianapolis, Indiana, United States
Community Cancer Center South
Indianapolis, Indiana, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Community Cancer Center North
Indianapolis, Indiana, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Saint Catherine Hospital
Indianapolis, Indiana, United States
Franciscan Health Mooresville
Mooresville, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Women's Diagnostic Center - Munster
Munster, Indiana, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States
Our Lady of The Lake
Baton Rouge, Louisiana, United States
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
MaineHealth Waldo Hospital
Belfast, Maine, United States
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
Winchester, Massachusetts, United States
UMass Memorial Medical Center - Memorial Division
Worcester, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States
Neurosurgeons of New Jersey-Ridgewood
Ridgewood, New Jersey, United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Valley Medical Group - Wayne Multispecialty Practice
Wayne, New Jersey, United States
Valley Health System-Hematology/Oncology
Westwood, New Jersey, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Island Gynecologic Oncology
Brightwaters, New York, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
The New York Hospital Medical Center of Queens
Flushing, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Mount Sinai Chelsea
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
Highland Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Westchester Medical Center
Valhalla, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Geauga Hospital
Chardon, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Saint Charles Health System
Bend, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
WellSpan Medical Oncology and Hematology
Hanover, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, United States
Forbes Hospital
Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Methodist Willowbrook Hospital
Houston, Texas, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Valley Medical Center
Renton, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
West Virginia University Charleston Division
Charleston, West Virginia, United States
Monongalia Hospital
Morgantown, West Virginia, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
The Moncton Hospital
Moncton, New Brunswick, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Algoma District Cancer Program Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Ehime University Hospital
Tōon, Ehime, Japan
Kure Medical Center and Chugoku Cancer Center
Kure, Hiroshima, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Saitama Medical University International Medical Center
Saitama, , Japan
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
Keimyung University-Dongsan Medical Center
Dalseo-gu, Daegu, South Korea
Samsung Changwon Hospital
Seoul, Gyeongsangnam-do, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Yonsei University Health System-Severance Hospital
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel RS, Shahin MS, Cantuaria GH, Girda E, Lokich E, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O'Cearbhaill RE, Baghdadi TA, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat Med. 2025 May;31(5):1539-1546. doi: 10.1038/s41591-025-03566-1. Epub 2025 Mar 5.
Morton M, Marcu I, Levine M, Cosgrove C, Backes F, O'Malley D, Chambers L. Evaluation of Efficacy and Adverse Events After Second Immunotherapy Exposure in Endometrial and Cervical Carcinoma. Obstet Gynecol. 2023 Aug 1;142(2):360-363. doi: 10.1097/AOG.0000000000005243. Epub 2023 Jul 5.
Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel R, Shahin MS, Cantuaria GH, Girda E, Mathews C, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O'Cearbhaill RE, Al Baghdadi T, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C. Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2159-2170. doi: 10.1056/NEJMoa2302312. Epub 2023 Mar 27.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2019-02186
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-GY018
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GY018
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2019-02186
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.