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Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04214067
Collaborator
NRG Oncology (Other)
168
Enrollment
278
Locations
2
Arms
47.8
Anticipated Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Brachytherapy
  • Radiation: External Beam Radiation Therapy
  • Biological: Pembrolizumab
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare the 3-year recurrence-free survival of women with high intermediate risk (HIR) stage I/II mismatch repair deficient (dMMR) endometrioid endometrial cancer treated with radiation and pembrolizumab (MK-3475) versus radiation alone.
SECONDARY OBJECTIVES:

  1. To describe the safety and tolerability of concurrent pembrolizumab (MK-3475) and radiation compared to radiation alone in patients with MMR deficient high intermediate risk endometrial cancer (HIR EC).

  2. To describe the recurrence patterns in each group. III. To measure recurrence free survival at 5 years in each group. IV. To estimate disease specific overall survival in each group. V. To determine whether the addition of pembrolizumab (MK-3475) to radiation, compared with radiation alone is associated with decreased quality of life at 6- and 24-weeks, as measured with the Functional Assessment of Cancer Therapy (FACT)-Endometrial (En) Trial Outcome Index (TOI), increased gastrointestinal (GI) symptoms as measured with the GI subscale, and increased fatigue as measured with the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue scale (short form).

  3. To validate the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) subscale, which assesses in cancer patients on immunotherapy.

EXPLORATORY OBJECTIVES:

  1. To explore the baseline tumor genetic and microenvironment parameters predictive of clinical benefit or resistance to immunotherapy.

  2. To determine whether the addition of pembrolizumab (MK-3475) to radiation, compared with radiation alone, is associated with decreased quality of life as measured with the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM subscale) and more self-reported bother from side effects as measured with a single item GP5 "I am bothered by side effects," a question from the FACT-En TOI.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo pelvic external beam radiation therapy (EBRT) daily for 5-6 weeks and vaginal brachytherapy completed within 7 days after completion of EBRT in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo EBRT and brachytherapy as in Arm I. Within 7 days prior to the start of radiation therapy, patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment with pembrolizumab repeats every 6 weeks for up to 1 year (9 cycles) in the absence of disease progression or unacceptable toxicity.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer
Actual Study Start Date :
Feb 7, 2020
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (EBRT, brachytherapy)

Patients undergo pelvic EBRT daily for 5-6 weeks and vaginal brachytherapy completed within 7 days after completion of EBRT in the absence of disease progression or unacceptable toxicity.

Radiation: Brachytherapy
Undergo vaginal brachytherapy
Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal

    • Radiation: External Beam Radiation Therapy
    Undergo EBRT
    Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies
    Experimental: Arm II (EBRT, brachytherapy, pembrolizumab)

    Patients undergo EBRT and brachytherapy as in Arm I. Within 7 days prior to the start of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 6 weeks for up to 1 year (9 cycles) in the absence of disease progression or unacceptable toxicity.

    Radiation: Brachytherapy
    Undergo vaginal brachytherapy
    Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal

    • Radiation: External Beam Radiation Therapy
    Undergo EBRT
    Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation

    • Biological: Pembrolizumab
    Given IV
    Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 3 year recurrence-free survival [Time from study entry (randomization) to the time of cancer recurrence, assessed at 3 years]

      Will be estimated using the Kaplan Meier method and treatment comparisons will be made using a stratified log-rank test.

    Secondary Outcome Measures

    1. Incidence of adverse events [12 months]

      Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) by treatment regimen. Will be evaluated descriptively using frequencies and percentages and will be reported using tables. Differences between treatment arms will be assessed through absolute deviations and contingency table analyses. All patients who receive treatment, will be evaluated for toxicity. Toxicities by type and maximum grade over the course of treatment and follow up will be summarized and by date of occurrence (acute toxicity and late adverse effects).

    2. Recurrence patterns [5 years]

      The cumulative incidences of vaginal recurrence, pelvic recurrence, retroperitoneal, and distant recurrence from endometrial cancer will be estimated within treatment regimen. Treatments will be compared graphically using Kaplan-Meier estimates of the survival function.

    3. 5 year recurrence free survival [Time from study entry (randomization) to the time of cancer recurrence, assessed at 5 years]

      Proportions will be compared by treatment using Fisher's exact test. This analysis may be delayed until the data are mature.

    4. Overall survival [Duration of time from study entry to time of death or the date of last contact, assessed up to 5 years]

      Will be estimated using the Kaplan Meier method and treatment comparisons will be made using a stratified log-rank test.

    5. Patients reported outcomes [Up to 2 years after starting treatment]

      Will be assessed by questionnaire.

    Other Outcome Measures

    1. Potential transformations of the severity of adverse events [12 months]

      An example of potential transformation of the severity of adverse events is whether or not the patient experienced >= grade 3 events. It will be assessed by CTCAE and treatment regimen.

    2. Biomarker analysis [Baseline]

      Will assess baseline genetic characteristics (e.g. mutations) and microenvironment parameters, treatment, and interactions between treatment and biomarkers in a Cox regression.

    3. Functional Assessment of Cancer Therapy (FACT)-Immune Checkpoint Modulator (ICM) subscale [Up to 2 years after starting treatment]

      Treatment differences in the FACT-ICM subscale and self-reported bother from side effects will be explored using a linear mixed model for repeated measures, adjusted for the baseline score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have:

    • Stage I endometrioid endometrial cancer and a combination of age and risk factors as listed below:

    • Age >= 70 and 1 or more risk factors

    • Age 50 - < 70 and 2 or more risk factors

    • Age < 50 and 3 risk factors

    • Risk factors:

    • Myometrial invasion >= 50%

    • Lymphovascular space invasion

    • Grade 2 or 3 OR

    • Stage II endometrioid endometrial cancer

    • Note: Patients with isolated tumor cells in sentinel lymph nodes are eligible (considered N0i) as long as there is no evidence of micro- or macro-metastases in any lymph nodes

    • Computed tomography (CT) or magnetic resonance imaging (MRI) abdomen or pelvis and either chest X-ray or CT chest demonstrating no evidence of disease outside of the uterus. Imaging can be performed pre-operatively or post-operatively. CT with contrast is the preferred modality. PET/CT is NOT to be used for any disease assessment or reassessment unless there is documentation that PET/CT is of diagnostic quality equal to CT with contrast

    • Patients must have deficient mismatch repair as demonstrated by lack of expression of at least one mismatch repair protein by immunohistochemistry (IHC) and/or evidence of microsatellite instability (MSI) high. The institutional pathology report documenting MMR deficiency must be submitted

    • Patients must have undergone surgical staging with at least hysterectomy, removal of cervix, bilateral (if both are present) salpingo-oophorectomy, and either sentinel lymph node assessment or complete pelvic +/- aortic lymphadenectomy. Secondary staging is allowed to determine stage. Patients with isolated tumor cells in sentinel lymph nodes are eligible (considered N0i) as long as there is no evidence of micro- or macro-metastases in any lymph nodes

    • Patients must have received no prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

    • Platelets >= 100,000/mcl (within 14 days prior to registration)

    • Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration)

    • Creatinine =< 1.5 x laboratory upper limit of normal (ULN) (within 14 days prior to registration)

    • Bilirubin =< 1.5 x ULN (within 14 days prior to registration) (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled)

    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 14 days prior to registration)

    • Thyroid stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy)

    • Patients must be registered between 1 and 8 weeks after initial (staging) surgery performed for the combined purpose of diagnosis and staging

    • Human immunodeficiency virus (HIV) testing is not required by protocol unless clinically indicated. Known HIV positive patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

    • 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 are currently participating and receiving cancer-directed study therapy for endometrial cancer or have participated in a study of an investigational agent and received cancer-directed study therapy for endometrial cancer within 4 weeks prior to registration

    • Patients who have received 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 MK-3475 (pembrolizumab) and/or its excipients

    • 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 with a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis

    • 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 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 (e.g. 10 mg of prednisone used for replacement therapy for adrenal insufficiency)

    • Patients who are lactating

    • 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

    • 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

    • Patients who have received any of the prohibited medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Community Cancer Institute Clovis California United States 93611
    3 University Oncology Associates Clovis California United States 93611
    4 John Muir Medical Center-Concord Campus Concord California United States 94520
    5 UC San Diego Moores Cancer Center La Jolla California United States 92093
    6 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    7 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    8 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
    9 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    10 John Muir Medical Center-Walnut Creek Walnut Creek California United States 94598
    11 University of Colorado Hospital Aurora Colorado United States 80045
    12 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    13 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    14 Memorial Hospital North Colorado Springs Colorado United States 80920
    15 Porter Adventist Hospital Denver Colorado United States 80210
    16 UCHealth Highlands Ranch Hospital Highlands Ranch Colorado United States 80129
    17 Littleton Adventist Hospital Littleton Colorado United States 80122
    18 Parker Adventist Hospital Parker Colorado United States 80138
    19 Danbury Hospital Danbury Connecticut United States 06810
    20 Smilow Cancer Hospital-Derby Care Center Derby Connecticut United States 06418
    21 Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut United States 06824
    22 Smilow Cancer Hospital Care Center at Glastonbury Glastonbury Connecticut United States 06033
    23 Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut United States 06830
    24 Smilow Cancer Hospital Care Center - Guiford Guilford Connecticut United States 06437
    25 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    26 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
    27 Yale University New Haven Connecticut United States 06520
    28 Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut United States 06473
    29 Norwalk Hospital Norwalk Connecticut United States 06856
    30 Smilow Cancer Hospital-Orange Care Center Orange Connecticut United States 06477
    31 Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut United States 06790
    32 Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut United States 06611
    33 Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut United States 06708
    34 Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut United States 06385
    35 Florida Gynecologic Oncology Fort Myers Florida United States 33905
    36 Regional Cancer Center-Lee Memorial Health System Fort Myers Florida United States 33905
    37 Northside Hospital Atlanta Georgia United States 30342
    38 Northside Hospital-Forsyth Cumming Georgia United States 30041
    39 Wellstar Kennestone Hospital Marietta Georgia United States 30060
    40 CTCA at Southeastern Regional Medical Center Newnan Georgia United States 30265
    41 Memorial Health University Medical Center Savannah Georgia United States 31404
    42 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    43 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    44 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    45 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    46 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    47 Queen's Medical Center Honolulu Hawaii United States 96813
    48 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    49 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    50 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    51 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    52 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    53 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    54 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    55 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    56 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    57 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    58 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    59 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    60 Centralia Oncology Clinic Centralia Illinois United States 62801
    61 Northwestern University Chicago Illinois United States 60611
    62 Rush University Medical Center Chicago Illinois United States 60612
    63 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    64 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    65 Decatur Memorial Hospital Decatur Illinois United States 62526
    66 Crossroads Cancer Center Effingham Illinois United States 62401
    67 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    68 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    69 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    70 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    71 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
    72 Loyola University Medical Center Maywood Illinois United States 60153
    73 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
    74 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    75 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
    76 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    77 Springfield Clinic Springfield Illinois United States 62702
    78 Memorial Medical Center Springfield Illinois United States 62781
    79 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    80 Midwestern Regional Medical Center Zion Illinois United States 60099
    81 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    82 Mary Greeley Medical Center Ames Iowa United States 50010
    83 McFarland Clinic PC - Ames Ames Iowa United States 50010
    84 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    85 Saint Elizabeth Healthcare Edgewood Edgewood Kentucky United States 41017
    86 Baptist Health Lexington Lexington Kentucky United States 40503
    87 Baptist Health Louisville Louisville Kentucky United States 40207
    88 East Jefferson General Hospital Metairie Louisiana United States 70006
    89 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    90 University Medical Center New Orleans New Orleans Louisiana United States 70112
    91 MaineHealth Coastal Cancer Treatment Center Bath Maine United States 04530
    92 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    93 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    94 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    95 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    96 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    97 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    98 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    99 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    100 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    101 William Beaumont Hospital - Troy Troy Michigan United States 48085
    102 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    103 Mercy Hospital Coon Rapids Minnesota United States 55433
    104 Fairview Southdale Hospital Edina Minnesota United States 55435
    105 Unity Hospital Fridley Minnesota United States 55432
    106 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    107 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    108 Monticello Cancer Center Monticello Minnesota United States 55362
    109 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    110 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    111 United Hospital Saint Paul Minnesota United States 55102
    112 Ridgeview Medical Center Waconia Minnesota United States 55387
    113 Rice Memorial Hospital Willmar Minnesota United States 56201
    114 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    115 Parkland Health Center - Farmington Farmington Missouri United States 63640
    116 Washington University School of Medicine Saint Louis Missouri United States 63110
    117 Mercy Hospital South Saint Louis Missouri United States 63128
    118 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    119 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    120 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    121 Mercy Hospital Springfield Springfield Missouri United States 65804
    122 CoxHealth South Hospital Springfield Missouri United States 65807
    123 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    124 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    125 Billings Clinic Cancer Center Billings Montana United States 59101
    126 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    127 Community Medical Hospital Missoula Montana United States 59804
    128 Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska United States 68114
    129 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    130 Oncology Associates PC Omaha Nebraska United States 68114
    131 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    132 Women's Cancer Center of Nevada Las Vegas Nevada United States 89106
    133 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    134 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    135 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    136 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    137 Virtua Samson Cancer Center Moorestown New Jersey United States 08057
    138 Jersey Shore Medical Center Neptune New Jersey United States 07753
    139 Virtua Voorhees Voorhees New Jersey United States 08043
    140 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    141 Women's Cancer Care Associates LLC Albany New York United States 12208
    142 New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York United States 11215
    143 Memorial Sloan Kettering Commack Commack New York United States 11725
    144 The New York Hospital Medical Center of Queens Flushing New York United States 11355
    145 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    146 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    147 NYU Winthrop Hospital Mineola New York United States 11501
    148 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    149 Mount Sinai Chelsea New York New York United States 10011
    150 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    151 Mount Sinai West New York New York United States 10019
    152 Mount Sinai Hospital New York New York United States 10029
    153 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    154 NYP/Weill Cornell Medical Center New York New York United States 10065
    155 Highland Hospital Rochester New York United States 14620
    156 University of Rochester Rochester New York United States 14642
    157 Stony Brook University Medical Center Stony Brook New York United States 11794
    158 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    159 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    160 Duke University Medical Center Durham North Carolina United States 27710
    161 Cone Health Cancer Center Greensboro North Carolina United States 27403
    162 Duke Women's Cancer Care Raleigh Raleigh North Carolina United States 27607
    163 Duke Raleigh Hospital Raleigh North Carolina United States 27609
    164 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    165 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    166 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    167 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    168 Aultman Health Foundation Canton Ohio United States 44710
    169 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
    170 Miami Valley Hospital South Centerville Ohio United States 45459
    171 Geauga Hospital Chardon Ohio United States 44024
    172 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    173 Bethesda North Hospital Cincinnati Ohio United States 45242
    174 Case Western Reserve University Cleveland Ohio United States 44106
    175 MetroHealth Medical Center Cleveland Ohio United States 44109
    176 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    177 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    178 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    179 Mount Carmel East Hospital Columbus Ohio United States 43213
    180 Riverside Methodist Hospital Columbus Ohio United States 43214
    181 The Mark H Zangmeister Center Columbus Ohio United States 43219
    182 Mount Carmel Health Center West Columbus Ohio United States 43222
    183 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    184 Miami Valley Hospital North Dayton Ohio United States 45415
    185 Dublin Methodist Hospital Dublin Ohio United States 43016
    186 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    187 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
    188 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    189 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    190 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    191 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    192 Saint Ann's Hospital Westerville Ohio United States 43081
    193 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    194 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    195 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    196 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    197 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    198 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    199 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    200 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    201 Providence Newberg Medical Center Newberg Oregon United States 97132
    202 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    203 Providence Portland Medical Center Portland Oregon United States 97213
    204 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    205 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    206 Carlisle Regional Cancer Center Carlisle Pennsylvania United States 17015
    207 Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    208 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    209 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    210 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    211 Lancaster General Ann B Barshinger Cancer Institute Lancaster Pennsylvania United States 17601
    212 Lancaster General Hospital Lancaster Pennsylvania United States 17602
    213 Sechler Family Cancer Center Lebanon Pennsylvania United States 17042
    214 UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania United States 17050
    215 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    216 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    217 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    218 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    219 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    220 Chester County Hospital West Chester Pennsylvania United States 19380
    221 Asplundh Cancer Pavilion Willow Grove Pennsylvania United States 19090
    222 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    223 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    224 WellSpan Health-York Hospital York Pennsylvania United States 17403
    225 Women and Infants Hospital Providence Rhode Island United States 02905
    226 Smilow Cancer Hospital Care Center - Westerly Westerly Rhode Island United States 02891
    227 Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina United States 29910
    228 Saint Francis Hospital Greenville South Carolina United States 29601
    229 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    230 Saint Francis Cancer Center Greenville South Carolina United States 29607
    231 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    232 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    233 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    234 MD Anderson in The Woodlands Conroe Texas United States 77384
    235 Parkland Memorial Hospital Dallas Texas United States 75235
    236 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    237 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    238 Ben Taub General Hospital Houston Texas United States 77030
    239 Houston Methodist Hospital Houston Texas United States 77030
    240 M D Anderson Cancer Center Houston Texas United States 77030
    241 Methodist Willowbrook Hospital Houston Texas United States 77070
    242 MD Anderson West Houston Houston Texas United States 77079
    243 Houston Methodist West Hospital Houston Texas United States 77094
    244 MD Anderson League City League City Texas United States 77573
    245 MD Anderson in Sugar Land Sugar Land Texas United States 77478
    246 Houston Methodist Sugar Land Hospital Sugar Land Texas United States 77479
    247 Houston Methodist The Woodlands Hospital The Woodlands Texas United States 77385
    248 Farmington Health Center Farmington Utah United States 84025
    249 University of Utah Sugarhouse Health Center Salt Lake City Utah United States 84106
    250 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    251 VCU Massey Cancer Center at Stony Point Richmond Virginia United States 23235
    252 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    253 Carilion Clinic Gynecological Oncology Roanoke Virginia United States 24016
    254 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    255 West Virginia University Charleston Division Charleston West Virginia United States 25304
    256 Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin United States 53045
    257 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    258 Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin United States 53132
    259 Ascension Southeast Wisconsin Hospital - Franklin Franklin Wisconsin United States 53132
    260 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    261 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    262 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    263 Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin United States 53097
    264 Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee Wisconsin United States 53210
    265 Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin United States 53211
    266 Ascension Saint Francis Hospital Milwaukee Wisconsin United States 53215
    267 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    268 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    269 Ascension All Saints Hospital Racine Wisconsin United States 53405
    270 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    271 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
    272 Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin United States 53226
    273 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    274 Cancer Center-Metro Medical Center Bayamon Bayamon Puerto Rico 00959-5060
    275 Doctors Cancer Center Manati Puerto Rico 00674
    276 San Juan Community Oncology Group San Juan Puerto Rico 00917
    277 Centro Comprensivo de Cancer de UPR San Juan Puerto Rico 00927
    278 San Juan City Hospital San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • NRG Oncology

    Investigators

    • Principal Investigator: Floor Backes, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04214067
    Other Study ID Numbers:
    • NCI-2019-08602
    • NCI-2019-08602
    • NRG-GY020
    • NRG-GY020
    • U10CA180868
    First Posted:
    Dec 30, 2019
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Carcinoma, Endometrioid
    Pembrolizumab

    Study Results

    No Results Posted as of Aug 23, 2022