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

July 30, 2026 updated by: National Cancer Institute (NCI)

A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

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 after a period of improvement (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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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) 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.

Study Type

Interventional

Enrollment (Actual)

813

Phase

  • Phase 3

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

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program Sault Area Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Hopital de la Cite-de-la-Sante
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Université de Montréal
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Japan
      • Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Hiroshima
      • Kure, Hiroshima, Japan, 737
        • Kure Medical Center and Chugoku Cancer Center
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
  • South Korea
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 120-752
        • Yonsei University Health System-Severance Hospital
      • Seoul, South Korea, 139-706
        • Korea Cancer Center Hospital
    • Daegu
      • Dalseo-gu, Daegu, South Korea, 42601
        • Keimyung University-Dongsan Medical Center
    • Gyeongsangnam-do
      • Seoul, Gyeongsangnam-do, South Korea, 51353
        • Samsung Changwon Hospital
    • Kyeonggi-do
      • Seongnam, Kyeonggi-do, South Korea, 463-707
        • Seoul National University Bundang Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • CTCA at Western Regional Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Baldwin Park, California, United States, 91706
        • Kaiser Permanente-Baldwin Park
      • Bellflower, California, United States, 90706
        • Kaiser Permanente-Bellflower
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Clovis, California, United States, 93611
        • Community Cancer Institute
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Harbor City, California, United States, 90710
        • Kaiser Permanente South Bay
      • Irvine, California, United States, 92618
        • Kaiser Permanente-Irvine
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Lancaster, California, United States, 93534
        • City of Hope Antelope Valley
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • Redding, California, United States, 96001
        • Mercy Regional Cancer Center
      • Redding, California, United States, 96002
        • Mercy Oncology Center
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, United States, 95816
        • Mercy Cancer Center - Sacramento
      • San Diego, California, United States, 92120
        • Kaiser Permanente-San Diego Zion
      • San Diego, California, United States, 92134
        • Naval Medical Center -San Diego
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Marcos, California, United States, 92078
        • Kaiser Permanente-San Marcos
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • South Pasadena, California, United States, 91030
        • City of Hope South Pasadena
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Upland, California, United States, 91786
        • City of Hope Upland
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, United States, 80920
        • Memorial Hospital North
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Cancer Care and Hematology-Fort Collins
      • Greeley, Colorado, United States, 80631
        • UCHealth Greeley Hospital
      • Greeley, Colorado, United States, 80631
        • Banner North Colorado Medical Center
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
      • Loveland, Colorado, United States, 80539
        • Banner North Colorado Medical Center - Loveland Campus
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Guilford, Connecticut, United States, 06437
        • Smilow Cancer Hospital Care Center - Guilford
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • North Haven, Connecticut, United States, 06473
        • Yale-New Haven Hospital North Haven Medical Center
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital/Bennett Cancer Center
      • Torrington, Connecticut, United States, 06790
        • Smilow Cancer Hospital-Torrington Care Center
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterbury, Connecticut, United States, 06708
        • Smilow Cancer Hospital-Waterbury Care Center
      • Waterford, Connecticut, United States, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
      • Washington D.C., District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Bradenton, Florida, United States, 34205
        • Florida Cancer Specialists - Bradenton Cancer Center
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists - Sarasota
      • Sarasota, Florida, United States, 34239
        • Florida Cancer Specialists - Sarasota Downtown
      • Venice, Florida, United States, 34285
        • Florida Cancer Specialists - Venice Island
      • Venice, Florida, United States, 34275
        • Florida Cancer Specialists - Venice Pinebrook
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Austell, Georgia, United States, 30106
        • Wellstar Cobb Hospital
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center-Gainesville
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
      • Marietta, Georgia, United States, 30060
        • WellStar Health System Inc
      • Newnan, Georgia, United States, 30265
        • CTCA at Southeastern Regional Medical Center
      • Roswell, Georgia, United States, 30076
        • Wellstar North Fulton Hospital
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
      • Smyrna, Georgia, United States, 30080
        • WellStar Vinings Health Park
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
    • 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
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, United States, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60612
        • Rush MD Anderson Cancer Center
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • New Lenox, Illinois, United States, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, United States, 60462
        • University of Chicago Medicine-Orland Park
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Northwest Cancer Center - Crown Point
      • Dyer, Indiana, United States, 46311
        • Northwest Oncology LLC
      • Hobart, Indiana, United States, 46342
        • Northwest Cancer Center - Hobart
      • Hobart, Indiana, United States, 46342
        • Saint Mary Medical Center
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46219
        • Community Cancer Center East
      • Indianapolis, Indiana, United States, 46227
        • Community Cancer Center South
      • Indianapolis, Indiana, United States, 46256
        • Community Cancer Center North
      • Indianapolis, Indiana, United States, 46260
        • Ascension Saint Vincent Indianapolis Hospital
      • Indianapolis, Indiana, United States, 46312
        • Saint Catherine Hospital
      • Mooresville, Indiana, United States, 46158
        • Franciscan Health Mooresville
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Munster, Indiana, United States, 46321
        • Women's Diagnostic Center - Munster
      • Valparaiso, Indiana, United States, 46383
        • Northwest Cancer Center - Valparaiso
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Fairway, Kansas, United States, 66205
        • University of Kansas Clinical Research Center
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Healthcare Edgewood
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • LSU Health Baton Rouge-North Clinic
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of The Lake
      • Baton Rouge, Louisiana, United States, 70817
        • Woman's Hospital
      • Baton Rouge, Louisiana, United States, 70817
        • Our Lady of the Lake Medical Oncology
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Physician Group
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Center
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Belfast, Maine, United States, 04915
        • MaineHealth Waldo Hospital
      • Biddeford, Maine, United States, 04005
        • MaineHealth Maine Medical Center - Biddeford
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, United States, 04073
        • MaineHealth Cancer Care and IV Therapy - Sanford
      • Scarborough, Maine, United States, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Hospital
      • Bel Air, Maryland, United States, 21014
        • UM Upper Chesapeake Medical Center
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
      • Easton, Maryland, United States, 21601
        • University of Maryland Shore Medical Center at Easton
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Winchester, Massachusetts, United States, 01890
        • Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center - Memorial Division
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Flint, Michigan, United States, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, United States, 48503
        • Cancer Hematology Centers - Flint
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39202
        • Mississippi Baptist Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Anaconda, Montana, United States, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Lakewood, New Jersey, United States, 08701
        • Monmouth Medical Center Southern Campus
      • Livingston, New Jersey, United States, 07039
        • Cooperman Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital - Luckow Pavilion
      • Ridgewood, New Jersey, United States, 07450
        • Neurosurgeons of New Jersey-Ridgewood
      • Ridgewood, New Jersey, United States, 07450
        • Valley Health System Ridgewood Campus
      • Somerville, New Jersey, United States, 08876
        • Robert Wood Johnson University Hospital Somerset
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
      • Voorhees Township, New Jersey, United States, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
      • Wayne, New Jersey, United States, 07470
        • Valley Medical Group - Wayne Multispecialty Practice
      • Westwood, New Jersey, United States, 07675
        • Valley Health System-Hematology/Oncology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Southwest Gynecologic Oncology Associates Inc
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
    • New York
      • Bay Shore, New York, United States, 11706
        • Northwell Health Imbert Cancer Center
      • Brightwaters, New York, United States, 11718
        • Island Gynecologic Oncology
      • Brooklyn, New York, United States, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Flushing, New York, United States, 11355
        • The New York Hospital Medical Center of Queens
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, United States, 11042
        • Northwell Health/Center for Advanced Medicine
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10065
        • NYP/Weill Cornell Medical Center
      • New York, New York, United States, 10011
        • Mount Sinai Chelsea
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Clinton, North Carolina, United States, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Jacksonville, North Carolina, United States, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Wilmington, North Carolina, United States, 28401
        • Novant Health New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South
      • Chardon, Ohio, United States, 44024
        • Geauga Hospital
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • 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
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • West Chester, Ohio, United States, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westlake, Ohio, United States, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Ontario, Oregon, United States, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Ephrata, Pennsylvania, United States, 17522
        • Ephrata Cancer Center
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, United States, 17331
        • WellSpan Medical Oncology and Hematology
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Jefferson Hospital
      • Johnstown, Pennsylvania, United States, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster General Ann B Barshinger Cancer Institute
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Lebanon, Pennsylvania, United States, 17042
        • Sechler Family Cancer Center
      • Monroeville, Pennsylvania, United States, 15146
        • Forbes Hospital
      • Monroeville, Pennsylvania, United States, 15146
        • UPMC Hillman Cancer Center - Monroeville
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Magee Womens Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, United States, 18510
        • Community Medical Center
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, United States, 15090
        • Wexford Health and Wellness Pavilion
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Cancer Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, United States, 77070
        • Methodist Willowbrook Hospital
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Sugar Land, Texas, United States, 77479
        • Houston Methodist Sugar Land Hospital
      • The Woodlands, Texas, United States, 77385
        • Houston Methodist The Woodlands Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, United States, 84106
        • University of Utah Sugarhouse Health Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Gig Harbor, Washington, United States, 98335
        • MultiCare Gig Harbor Medical Park
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Renton, Washington, United States, 98055
        • Valley Medical Center
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Charleston Division
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
      • Morgantown, West Virginia, United States, 26505
        • Monongalia Hospital
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • 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
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • 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
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • 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
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • 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
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston

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

No

Description

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.
  • 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 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 (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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Other: Placebo Administration
Given IV
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Experimental: 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.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months.
Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events.
Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events With Grade 3 (or Higher)
Time Frame: For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months.
Assessed by Common Terminology Criteria for Adverse Events (CTCAE V5.0). The endpoint is the count of participants with an adverse event of grade 3 (or higher) by treatment group.
For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months.
Objective Tumor Response
Time Frame: For the time frame for tumor response, the interquartile range was (2.27 months, 8.66 months) and the maximum was 36.37 months.
Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.
For the time frame for tumor response, the interquartile range was (2.27 months, 8.66 months) and the maximum was 36.37 months.
Duration of Objective Response
Time Frame: For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.
The time difference between the dates of first response and first progression; patients who do not progress are considered censored. Note: for Arm 2 (dMMR Cohort), the upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.
For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.
Overall Survival (OS)
Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 5 years
Overall Survival (OS). This endpoint will be assessed by Kaplan-Meier.
Time from study entry to time of death or the date of last contact, assessed up to 5 years
Quality of Life (QoL) in pMMR Patients Only
Time Frame: 0-54 weeks from start of treatment
QoL are collected in pMMR patients only and measured with the Function Assessment of Cancer Therapy -Endometrial Trial Outcome Index (FACT En-TOI). The FACT-En TOI scores range 0 - 120 with a larger score suggesting better or favorable state of QOL.
0-54 weeks from start of treatment
Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC
Time Frame: IHC testing values (for both central and institutional) were collected at baseline.
Concordance between institutional MMR IHC testing and centralized MMR IHC. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics including the kappa statistic (e.g. Cohen's kappa coefficient).
IHC testing values (for both central and institutional) were collected at baseline.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity
Time Frame: 0-54 weeks from start of treatment
Patient-reported neurotoxicity will be measured with FACT/GOG-Ntx subscale (short form).
0-54 weeks from start of treatment
Effect of Pembrolizumab on PFS and OS by Program Death Ligand 1 (PD-L1) IHC
Time Frame: 5 years
Will assess the effect of pembrolizumab on PFS and OS by PD-L1 (combined positive score [CPS]) within proficient MMR (pMMR) and deficient MMR (dMMR) populations. The effectiveness of pembrolizumab will be compared by PD-L1 status (CPS). A formal test will be conducted by examining the interaction term between pembrolizumab treatment (yes or no) with PD-L1 status. The association between PD-L1 CPS status and MMR IHC status will be assessed with odds ratios. A test may be conducted with a Fisher's Exact Test, and confidence intervals will be provided.
5 years
Association Between PD-L1 IHC and MMR Status
Time Frame: 5 years
Measures of association between PD-L1 IHC (CPS) and MMR IHC status. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient).
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
Canadian Cancer Trials Group

Investigators

  • Principal Investigator: Ramez N Eskander, NRG Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 22, 2019

Primary Completion (Actual)

December 16, 2022

Study Completion (Estimated)

September 26, 2026

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2019-02186 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NRG-GY018 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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