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在错配修复系统缺陷 (dMMR) 复发性子宫内膜癌中测试 Nivolumab 联合或不联合 Ipilimumab

2026年11月3日 更新者：National Cancer Institute (NCI)

Nivolumab 和 Ipilimumab 与 Nivolumab 单药治疗在有缺陷的错配修复系统复发性子宫内膜癌患者中的随机 II 期试验

This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

PRIMARY OBJECTIVE:

I. To assess efficacy in terms of progression-free survival (PFS) for immunotherapy with dual immune checkpoint blockade (nivolumab/ipilimumab) versus (vs.) monotherapy (nivolumab) in patients with recurrent mismatch repair (MMR) deficient endometrial carcinoma with measurable or non-measurable (detectable) disease.

SECONDARY OBJECTIVES:

I. To evaluate the overall survival (OS) as estimated from time of enrollment to last follow-up or death.

II. To evaluate the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in those with measurable disease at start of treatment.

III. To evaluate progression-free survival at 6 months. IV. To evaluate the nature, frequency and degree of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

V. To evaluate PFS and objective response rate in patients with prior anti-PD1/PDL1 therapy and compare efficacy of dual immune checkpoint inhibition vs. anti-PD1 monotherapy.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or complete response (CR). Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR.

ARM II: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR.

MAINTENANCE THERAPY: Patients achieving CR on Arm I or II receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity.

Additionally, all patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. All patients also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial.

Patients are followed every 3 months for 2 years, and then, every 6 months for 3 years.

研究类型

介入性

注册 (估计的)

81

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • 招聘中
        • University of Alabama at Birmingham Cancer Center
        • 首席研究员：
          • Michael D. Toboni
        • 接触：
    • Georgia
      • Athens、Georgia、美国、30607
        • 暂停
        • University Cancer and Blood Center LLC
      • Augusta、Georgia、美国、30912
        • 招聘中
        • Augusta University Medical Center
        • 接触：
        • 首席研究员：
          • Bunja J. Rungruang
    • Idaho
      • Boise、Idaho、美国、83712
        • 招聘中
        • Saint Luke's Cancer Institute - Boise
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Boise、Idaho、美国、83706
        • 暂停
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell、Idaho、美国、83605
        • 暂停
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene、Idaho、美国、83814
        • 招聘中
        • Kootenai Health - Coeur d'Alene
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Fruitland、Idaho、美国、83619
        • 招聘中
        • Saint Luke's Cancer Institute - Fruitland
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Meridian、Idaho、美国、83642
        • 招聘中
        • Saint Luke's Cancer Institute - Meridian
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Nampa、Idaho、美国、83687
        • 招聘中
        • Saint Luke's Cancer Institute - Nampa
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Nampa、Idaho、美国、83687
        • 暂停
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls、Idaho、美国、83854
        • 招聘中
        • Kootenai Clinic Cancer Services - Post Falls
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Sandpoint、Idaho、美国、83864
        • 招聘中
        • Kootenai Clinic Cancer Services - Sandpoint
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
    • Illinois
      • Chicago、Illinois、美国、60612
        • 暂停
        • University of Illinois
      • Danville、Illinois、美国、61832
        • 招聘中
        • Carle at The Riverfront
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
      • Effingham、Illinois、美国、62401
        • 招聘中
        • Carle Physician Group-Effingham
        • 接触：
        • 首席研究员：
          • Pratima Chalasani
      • Mattoon、Illinois、美国、61938
        • 招聘中
        • Carle Physician Group-Mattoon/Charleston
        • 接触：
        • 首席研究员：
          • Pratima Chalasani
      • Normal、Illinois、美国、61761
        • 招聘中
        • Carle BroMenn Medical Center
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
      • Normal、Illinois、美国、61761
        • 招聘中
        • Carle Cancer Institute Normal
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
      • Urbana、Illinois、美国、61801
        • 招聘中
        • Carle Cancer Center
        • 接触：
        • 首席研究员：
          • Pratima Chalasani
    • Indiana
      • Carmel、Indiana、美国、46032
        • 暂停
        • IU Health North Hospital
      • Crown Point、Indiana、美国、46307
        • 招聘中
        • Northwest Cancer Center - Crown Point
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
      • Dyer、Indiana、美国、46311
        • 招聘中
        • Northwest Oncology LLC
        • 接触：
          • Site Public Contact
          • 电话号码：219-924-8178
        • 首席研究员：
          • Pratima Chalasani
      • Hobart、Indiana、美国、46342
        • 招聘中
        • Northwest Cancer Center - Hobart
        • 接触：
          • Site Public Contact
          • 电话号码：219-947-1795
        • 首席研究员：
          • Pratima Chalasani
      • Hobart、Indiana、美国、46342
        • 招聘中
        • Saint Mary Medical Center
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Indiana University/Melvin and Bren Simon Cancer Center
        • 接触：
        • 首席研究员：
          • Jessica E. Parker
      • Indianapolis、Indiana、美国、46312
        • 招聘中
        • Saint Catherine Hospital
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
      • Munster、Indiana、美国、46321
        • 招聘中
        • The Community Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：219-836-3349
        • 首席研究员：
          • Pratima Chalasani
      • Munster、Indiana、美国、46321
        • 招聘中
        • Women's Diagnostic Center - Munster
        • 接触：
        • 首席研究员：
          • Pratima Chalasani
      • Valparaiso、Indiana、美国、46383
        • 招聘中
        • Northwest Cancer Center - Valparaiso
        • 首席研究员：
          • Pratima Chalasani
        • 接触：
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 招聘中
        • University of Iowa/Holden Comprehensive Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：800-237-1225
        • 首席研究员：
          • David P. Bender
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • 招聘中
        • The James Graham Brown Cancer Center at University of Louisville
        • 接触：
          • Site Public Contact
          • 电话号码：502-562-3429
        • 首席研究员：
          • Jason A. Chesney
      • Louisville、Kentucky、美国、40245
        • 招聘中
        • UofL Health Medical Center Northeast
        • 接触：
        • 首席研究员：
          • Jason A. Chesney
    • Maine
      • Scarborough、Maine、美国、04074
        • 招聘中
        • MaineHealth Maine Medical Center- Scarborough
        • 首席研究员：
          • Leslie S. Bradford
        • 接触：
    • Michigan
      • Battle Creek、Michigan、美国、49017
        • 招聘中
        • Bronson Battle Creek
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Grand Rapids、Michigan、美国、49503
        • 暂停
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Kalamazoo、Michigan、美国、49007
        • 招聘中
        • Bronson Methodist Hospital
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Kalamazoo、Michigan、美国、49007
        • 招聘中
        • West Michigan Cancer Center
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Kalamazoo、Michigan、美国、49009
        • 招聘中
        • Beacon Kalamazoo Cancer Center
        • 首席研究员：
          • Kathleen Y. Butler
        • 接触：
          • Site Public Contact
          • 电话号码：574-647-7370
      • Muskegon、Michigan、美国、49444
        • 暂停
        • Trinity Health Muskegon Hospital
      • Niles、Michigan、美国、49120
        • 招聘中
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：616-391-1230
        • 首席研究员：
          • Kathleen Y. Butler
      • Norton Shores、Michigan、美国、49444
        • 暂停
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City、Michigan、美国、49677
        • 招聘中
        • Corewell Health Reed City Hospital
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Saint Joseph、Michigan、美国、49085
        • 招聘中
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Saint Joseph、Michigan、美国、49085
        • 招聘中
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Traverse City、Michigan、美国、49684
        • 招聘中
        • Munson Medical Center
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
      • Wyoming、Michigan、美国、49519
        • 招聘中
        • University of Michigan Health - West
        • 接触：
        • 首席研究员：
          • Kathleen Y. Butler
    • Minnesota
      • Coon Rapids、Minnesota、美国、55433
        • 招聘中
        • Mercy Hospital
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Deer River、Minnesota、美国、56636
        • 招聘中
        • Essentia Health - Deer River Clinic
        • 接触：
        • 首席研究员：
          • Bret E. Friday
      • Duluth、Minnesota、美国、55805
        • 招聘中
        • Essentia Health Cancer Center
        • 接触：
        • 首席研究员：
          • Bret E. Friday
      • Duluth、Minnesota、美国、55805
        • 招聘中
        • Miller-Dwan Hospital
        • 接触：
        • 首席研究员：
          • Bret E. Friday
      • Edina、Minnesota、美国、55435
        • 招聘中
        • Fairview Southdale Hospital
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Edina、Minnesota、美国、55435
        • 招聘中
        • Minnesota Oncology - Edina
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Hibbing、Minnesota、美国、55746
        • 招聘中
        • Essentia Health Hibbing Clinic
        • 首席研究员：
          • Bret E. Friday
        • 接触：
          • Site Public Contact
          • 电话号码：218-786-3308
      • Minneapolis、Minnesota、美国、55407
        • 招聘中
        • Abbott-Northwestern Hospital
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Saint Louis Park、Minnesota、美国、55416
        • 招聘中
        • Park Nicollet Clinic - Saint Louis Park
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Saint Paul、Minnesota、美国、55101
        • 招聘中
        • Regions Hospital
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Saint Paul、Minnesota、美国、55102
        • 招聘中
        • United Hospital
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Sandstone、Minnesota、美国、55072
        • 招聘中
        • Essentia Health Sandstone
        • 接触：
        • 首席研究员：
          • Bret E. Friday
      • Shakopee、Minnesota、美国、55379
        • 招聘中
        • Saint Francis Regional Medical Center
        • 接触：
        • 首席研究员：
          • Adrianne Mallen
      • Virginia、Minnesota、美国、55792
        • 招聘中
        • Essentia Health Virginia Clinic
        • 接触：
        • 首席研究员：
          • Bret E. Friday
    • Missouri
      • Columbia、Missouri、美国、65212
        • 暂停
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School of Medicine
        • 接触：
        • 首席研究员：
          • Premal H. Thaker
    • Montana
      • Anaconda、Montana、美国、59711
        • 招聘中
        • Community Hospital of Anaconda
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Billings、Montana、美国、59101
        • 招聘中
        • Billings Clinic Cancer Center
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Billings、Montana、美国、59102
        • 招聘中
        • Saint Vincent Frontier Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：800-648-6274
        • 首席研究员：
          • Megan Petersen
      • Billings、Montana、美国、59106
        • 招聘中
        • Intermountain Health West End Clinic
        • 接触：
          • Site Public Contact
          • 电话号码：406-238-6685
        • 首席研究员：
          • Megan Petersen
      • Bozeman、Montana、美国、59715
        • 招聘中
        • Bozeman Health Deaconess Hospital
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Great Falls、Montana、美国、59405
        • 招聘中
        • Benefis Sletten Cancer Institute
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Kalispell、Montana、美国、59901
        • 招聘中
        • Logan Health Medical Center
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
      • Missoula、Montana、美国、59804
        • 招聘中
        • Community Medical Center
        • 首席研究员：
          • John M. Schallenkamp
        • 接触：
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • 招聘中
        • Nebraska Methodist Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：402-354-5144
        • 首席研究员：
          • Brent J. Tierney
    • Nevada
      • Las Vegas、Nevada、美国、89106
        • 招聘中
        • Women's Cancer Center of Nevada
        • 首席研究员：
          • Nicola M. Spirtos
        • 接触：
          • Site Public Contact
          • 电话号码：702-851-4672
    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • 招聘中
        • University of New Mexico Cancer Center
        • 接触：
        • 首席研究员：
          • Carolyn Y. Muller
    • New York
      • Buffalo、New York、美国、14263
        • 主动，不招人
        • Roswell Park Cancer Institute
      • Rochester、New York、美国、14642
        • 招聘中
        • University of Rochester
        • 接触：
          • Site Public Contact
          • 电话号码：585-275-5830
        • 首席研究员：
          • Rachael Turner
      • Syracuse、New York、美国、13210
        • 招聘中
        • State University of New York Upstate Medical University
        • 接触：
          • Site Public Contact
          • 电话号码：315-464-5476
        • 首席研究员：
          • Mary J. Cunningham
      • Webster、New York、美国、14580
    • North Carolina
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke University Medical Center
        • 首席研究员：
          • Angeles A. Secord
        • 接触：
          • Site Public Contact
          • 电话号码：888-275-3853
      • Raleigh、North Carolina、美国、27607
        • 招聘中
        • Duke Women's Cancer Care Raleigh
        • 首席研究员：
          • Angeles A. Secord
        • 接触：
          • Site Public Contact
          • 电话号码：919-785-4878
    • North Dakota
      • Fargo、North Dakota、美国、58103
        • 招聘中
        • Essentia Health Cancer Center-South University Clinic
        • 接触：
        • 首席研究员：
          • Bret E. Friday
    • Ohio
      • Beachwood、Ohio、美国、44122
        • 招聘中
        • UHHS-Chagrin Highlands Medical Center
        • 接触：
        • 首席研究员：
          • Amy Armstrong
      • Centerville、Ohio、美国、45459
        • 招聘中
        • Miami Valley Hospital South
        • 接触：
        • 首席研究员：
          • Michael S. Guy
      • Chardon、Ohio、美国、44024
        • 招聘中
        • Geauga Hospital
        • 接触：
        • 首席研究员：
          • Amy Armstrong
      • Cincinnati、Ohio、美国、45220
        • 主动，不招人
        • Good Samaritan Hospital - Cincinnati
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic Foundation
        • 接触：
        • 首席研究员：
          • Peter G. Rose
      • Cleveland、Ohio、美国、44106
        • 招聘中
        • Case Western Reserve University
        • 接触：
        • 首席研究员：
          • Amy Armstrong
      • Cleveland、Ohio、美国、44111
        • 招聘中
        • Cleveland Clinic Cancer Center/Fairview Hospital
        • 接触：
        • 首席研究员：
          • Peter G. Rose
      • Columbus、Ohio、美国、43210
        • 招聘中
        • Ohio State University Comprehensive Cancer Center
        • 接触：
        • 首席研究员：
          • Floor Backes
      • Mayfield Heights、Ohio、美国、44124
        • 招聘中
        • Hillcrest Hospital Cancer Center
        • 接触：
        • 首席研究员：
          • Peter G. Rose
      • Mentor、Ohio、美国、44060
        • 招聘中
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • 接触：
        • 首席研究员：
          • Amy Armstrong
      • Parma、Ohio、美国、44129
        • 招聘中
        • University Hospitals Parma Medical Center
        • 接触：
        • 首席研究员：
          • Amy Armstrong
      • Westlake、Ohio、美国、44145
        • 招聘中
        • UH Seidman Cancer Center at Saint John Medical Center
        • 接触：
        • 首席研究员：
          • Amy Armstrong
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • 招聘中
        • University of Oklahoma Health Sciences Center
        • 接触：
        • 首席研究员：
          • Christina Washington
      • Tulsa、Oklahoma、美国、74146
        • 主动，不招人
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Ontario、Oregon、美国、97914
        • 暂停
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland、Oregon、美国、97213
        • 招聘中
        • Providence Portland Medical Center
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Portland、Oregon、美国、97225
        • 招聘中
        • Providence Saint Vincent Medical Center
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
    • Pennsylvania
      • Beaver、Pennsylvania、美国、15009
        • 招聘中
        • UPMC-Heritage Valley Health System Beaver
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Butler、Pennsylvania、美国、16001
        • 招聘中
        • UPMC Hillman Cancer Center at Butler Health System
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Cranberry Township、Pennsylvania、美国、16066
        • 招聘中
        • UPMC Hillman Cancer Center - Passavant - Cranberry
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Erie、Pennsylvania、美国、16505
        • 招聘中
        • UPMC Hillman Cancer Center Erie
        • 首席研究员：
          • Alexander B. Olawaiye
        • 接触：
      • Farrell、Pennsylvania、美国、16121
        • 招聘中
        • UPMC Cancer Center at UPMC Horizon
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Greensburg、Pennsylvania、美国、15601
        • 招聘中
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • 接触：
          • Site Public Contact
          • 电话号码：724-838-1900
        • 首席研究员：
          • Alexander B. Olawaiye
      • Indiana、Pennsylvania、美国、15701
        • 招聘中
        • IRMC Cancer Center
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Johnstown、Pennsylvania、美国、15901
        • 招聘中
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：814-534-4724
        • 首席研究员：
          • Alexander B. Olawaiye
      • McKeesport、Pennsylvania、美国、15132
        • 招聘中
        • UPMC Cancer Center at UPMC McKeesport
        • 接触：
          • Site Public Contact
          • 电话号码：412-647-8073
        • 首席研究员：
          • Alexander B. Olawaiye
      • Mechanicsburg、Pennsylvania、美国、17050
        • 招聘中
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Monroeville、Pennsylvania、美国、15146
        • 招聘中
        • UPMC Hillman Cancer Center - Monroeville
        • 首席研究员：
          • Alexander B. Olawaiye
        • 接触：
      • Moon Township、Pennsylvania、美国、15108
        • 招聘中
        • UPMC Hillman Cancer Center in Coraopolis
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Mount Pleasant、Pennsylvania、美国、15666
        • 招聘中
        • UPMC Hillman Cancer Center - Part of Frick Hospital
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • N. Huntingdon、Pennsylvania、美国、15642
        • 招聘中
        • Arnold Palmer Cancer Center Medical Oncology Norwin
        • 首席研究员：
          • Alexander B. Olawaiye
        • 接触：
      • Natrona Heights、Pennsylvania、美国、15065
        • 招聘中
        • UPMC Cancer Center-Natrona Heights
        • 接触：
          • Site Public Contact
          • 电话号码：724-230-3030
        • 首席研究员：
          • Alexander B. Olawaiye
      • New Castle、Pennsylvania、美国、16105
        • 招聘中
        • UPMC Hillman Cancer Center - New Castle
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • Pittsburgh、Pennsylvania、美国、15213
        • 招聘中
        • UPMC-Magee Womens Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：412-647-2811
        • 首席研究员：
          • Alexander B. Olawaiye
      • Pittsburgh、Pennsylvania、美国、15215
        • 招聘中
        • UPMC-Saint Margaret
        • 接触：
          • Site Public Contact
          • 电话号码：412-784-4900
        • 首席研究员：
          • Alexander B. Olawaiye
      • Pittsburgh、Pennsylvania、美国、15219
        • 招聘中
        • UPMC-Mercy Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：800-533-8762
        • 首席研究员：
          • Alexander B. Olawaiye
      • Pittsburgh、Pennsylvania、美国、15237
        • 招聘中
        • UPMC-Passavant Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：412-367-6454
        • 首席研究员：
          • Alexander B. Olawaiye
      • Pittsburgh、Pennsylvania、美国、15243
        • 招聘中
        • UPMC-Saint Clair Hospital Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：412-502-3920
        • 首席研究员：
          • Alexander B. Olawaiye
      • Pittsburgh、Pennsylvania、美国、15232
        • 招聘中
        • UPMC Hillman Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：412-647-8073
        • 首席研究员：
          • Alexander B. Olawaiye
      • Seneca、Pennsylvania、美国、16346
        • 招聘中
        • UPMC Cancer Center at UPMC Northwest
        • 接触：
          • Site Public Contact
          • 电话号码：814-676-7900
        • 首席研究员：
          • Alexander B. Olawaiye
      • Washington、Pennsylvania、美国、15301
        • 招聘中
        • UPMC Cancer Center-Washington
        • 接触：
        • 首席研究员：
          • Alexander B. Olawaiye
      • West Mifflin、Pennsylvania、美国、15122
        • 招聘中
        • UPMC West Mifflin-Cancer Center Jefferson
        • 接触：
          • Site Public Contact
          • 电话号码：412-653-8100
        • 首席研究员：
          • Alexander B. Olawaiye
    • Rhode Island
      • Providence、Rhode Island、美国、02905
        • 招聘中
        • Women and Infants Hospital
        • 接触：
          • Site Public Contact
          • 电话号码：401-274-1122
        • 首席研究员：
          • Cara A. Mathews
    • Texas
      • Dallas、Texas、美国、75390
        • 招聘中
        • UT Southwestern/Simmons Cancer Center-Dallas
        • 接触：
        • 首席研究员：
          • David S. Miller
      • Dallas、Texas、美国、75235
        • 招聘中
        • Parkland Memorial Hospital
        • 接触：
        • 首席研究员：
          • David S. Miller
      • Fort Worth、Texas、美国、76104
        • 暂停
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson、Texas、美国、75080
        • 招聘中
        • UT Southwestern Clinical Center at Richardson/Plano
        • 接触：
        • 首席研究员：
          • David S. Miller
    • Virginia
      • Charlottesville、Virginia、美国、22908
      • Richmond、Virginia、美国、23229
        • 招聘中
        • Henrico Doctor's Hospital
        • 首席研究员：
          • Andrew S. Kennedy
        • 接触：
          • Site Public Contact
          • 电话号码：804-591-4152
      • Richmond、Virginia、美国、23298
        • 主动，不招人
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Edmonds、Washington、美国、98026
        • 招聘中
        • Swedish Cancer Institute-Edmonds
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Issaquah、Washington、美国、98029
        • 招聘中
        • Swedish Cancer Institute-Issaquah
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Seattle、Washington、美国、98122
        • 招聘中
        • Swedish Medical Center-First Hill
        • 首席研究员：
          • Dan S. Zuckerman
        • 接触：
      • Seattle、Washington、美国、98109
        • 主动，不招人
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Ashland、Wisconsin、美国、54806
        • 招聘中
        • Duluth Clinic Ashland
        • 接触：
        • 首席研究员：
          • Bret E. Friday
      • Ashland、Wisconsin、美国、54806
        • 招聘中
        • Northwest Wisconsin Cancer Center
        • 接触：
        • 首席研究员：
          • Bret E. Friday

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Patients with measurable or non-measurable (detectable) recurrent endometrial cancer

  • Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

  • Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:

    • All other lesions (or sites of disease), including small lesions (longest diameter <10 mm or pathological lymph nodes with >= 10 to < 15 mm short axis), are considered non-measurable disease
    • Ascites and/or pleural effusion attributed to tumor
    • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions

  • Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing [NGS] panel)

    • Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results

  • 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, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)

  • Patients may have received 1-2 prior lines of systemic therapy:

    • Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition

  • 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 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 registration

  • Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)

  • Age >= 18

  • Eastern Cooperative Oncology Group (ECOG) 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

  • Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia < grade 2 within 28 days prior to registration)

  • Thyroid-stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated

  • Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery

  • As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval < 450 msec

  • The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception

    • WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

  • 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

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial

  • Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load 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

  • 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 the patient is stable off steroids for at least one month

  • 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

  • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible

  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

Exclusion Criteria:

  • Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma

  • Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities

  • Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents

  • Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent

  • Patients on immunosuppressive therapy, with the exception of:

    • Intra-nasal, inhaled, topical or local steroid injections
    • Premedication for hypersensitivity reaction

  • 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, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

  • Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody

  • Patients with 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

  • Women who are pregnant or unwilling to discontinue nursing

  • Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm I (nivolumab and ipilimumab)

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or CR. Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR.

MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity.

Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.
生物：Ipilimumab

Given IV

其他名称：
  • 抗细胞毒性 T 淋巴细胞相关抗原 4 单克隆抗体
  • BMS-734016
  • 易普利姆玛生物仿制药 CS1002
  • MDX-010
  • MDX-CTLA4
  • 耶沃伊
  • MDX010
  • BMS734016
  • 建筑管理系统 734016
  • MDX 010
程序：Computed Tomography

Undergo CT

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
生物：Nivolumab

Given IV

其他名称：
  • BMS-936558
  • MDX-1106
  • 尼沃
  • ONO-4538
  • 欧狄沃
  • CMAB819
  • Nivolumab 生物类似药 CMAB819
  • MDX 1106
  • MDX1106
  • 电池管理系统 936558
  • 总部血压206
  • 纳武单抗生物仿制药 ABP 206
  • BCD-263
  • 纳武单抗生物仿制药 BCD-263
  • BMS936558
  • 小野4538
程序：Biospecimen Collection

Undergo collection of tissue and/or blood samples

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
有源比较器：Arm II (nivolumab)

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR.

MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity.

Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.
程序：Computed Tomography

Undergo CT

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
生物：Nivolumab

Given IV

其他名称：
  • BMS-936558
  • MDX-1106
  • 尼沃
  • ONO-4538
  • 欧狄沃
  • CMAB819
  • Nivolumab 生物类似药 CMAB819
  • MDX 1106
  • MDX1106
  • 电池管理系统 936558
  • 总部血压206
  • 纳武单抗生物仿制药 ABP 206
  • BCD-263
  • 纳武单抗生物仿制药 BCD-263
  • BMS936558
  • 小野4538
程序：Biospecimen Collection

Undergo collection of tissue and/or blood samples

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-free survival (PFS)
大体时间：From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years after randomization

The statistical test used for decision making is the stratified, standardized log-rank test (Z) based on PFS. For the safety lead-in analysis, the primary endpoint is the observation of at least one dose-limiting toxicity (DLT) in the first 3 cycles of treatment. Patients are classified as having a DLT in 3 cycles or receiving adequate treatment.
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years after randomization

次要结果测量

结果测量
措施说明
大体时间
Overall survival (OS)
大体时间：Up to 5 years after randomization

Will be assessed when the PFS data are mature. The null hypothesis will be that the hazard of death in regimen 1 is equal to the hazard of death in regimen 2. That is, Ho: HR = 1.00. The alternative will be that Ha: HR < 1.00 (regimen 1 to 2). The number of deaths is unknown.
Up to 5 years after randomization
Objective tumor response (ORR)
大体时间：Up to 5 years after randomization

Defined as the frequency of patients who have either a partial or complete response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The number of patients with responses will be tabulated by the treatment they were randomized to. Fisher's Exact Test will be used to test the hypothesis that the probabilities of response in each arm is the same. ORR will be evaluated only in patients who had measurable disease per RECIST 1.1 before starting treatment.
Up to 5 years after randomization
Progression-free survival (PFS) at 6 months
大体时间：From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months after randomization

A patient who survives at least 6 months progression-free will be considered to have had a successful outcome. Those who progress or die within 6 months are considered treatment failures, and those who survive progression-free for less than 6 months will be considered to have an unknown outcome or indeterminate. If the patient's status cannot be determined, she will be moved to the "failure" status for analysis. Like tumor response, the hypothesis of equivalent probabilities will be assessed with Fisher's Exact Test.
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months after randomization
Incidence of adverse events
大体时间：Up to 5 years after randomization

Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE). Will be tabulated by frequency and severity by treatment regimen. The treatment regimens will be compared by classifying the toxicities as severe or not and tested for equivalent probabilities by Fisher's Exact Test or whether the estimated probabilities of severe toxicities diverge by more than 10%.
Up to 5 years after randomization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

合作者

NRG Oncology

调查人员

  • 首席研究员：Haider S Mahdi、NRG Oncology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年6月2日

初级完成 (估计的)

2032年7月30日

研究完成 (估计的)

2032年7月30日

研究注册日期

首次提交

2021年11月6日

首先提交符合 QC 标准的

2021年11月6日

首次发布 (实际的)

2021年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NCI-2021-11881
  • U10CA180868 (美国 NIH 拨款/合同)
  • NCI-2021-11881 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • NRG-GY025 (其他标识符：CTEP)
  • NRG-GY025 (其他标识符：NRG Oncology)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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