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Test di nivolumab con o senza ipilimumab nel sistema di riparazione del mismatch carente (dMMR) Carcinoma endometriale ricorrente

3 novembre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase II su nivolumab e ipilimumab rispetto alla monoterapia con nivolumab in pazienti con carcinoma endometriale recidivante del sistema di riparazione del mismatch carente

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

81

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Reclutamento
        • University of Alabama at Birmingham Cancer Center
        • Investigatore principale:
          • Michael D. Toboni
        • Contatto:
    • Georgia
      • Athens, Georgia, Stati Uniti, 30607
        • Sospeso
        • University Cancer and Blood Center LLC
      • Augusta, Georgia, Stati Uniti, 30912
        • Reclutamento
        • Augusta University Medical Center
        • Contatto:
        • Investigatore principale:
          • Bunja J. Rungruang
    • Idaho
      • Boise, Idaho, Stati Uniti, 83712
        • Reclutamento
        • Saint Luke's Cancer Institute - Boise
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Boise, Idaho, Stati Uniti, 83706
        • Sospeso
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, Stati Uniti, 83605
        • Sospeso
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Stati Uniti, 83814
        • Reclutamento
        • Kootenai Health - Coeur d'Alene
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Fruitland, Idaho, Stati Uniti, 83619
        • Reclutamento
        • Saint Luke's Cancer Institute - Fruitland
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Meridian, Idaho, Stati Uniti, 83642
        • Reclutamento
        • Saint Luke's Cancer Institute - Meridian
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Luke's Cancer Institute - Nampa
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Nampa, Idaho, Stati Uniti, 83687
        • Sospeso
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, Stati Uniti, 83854
        • Reclutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Sandpoint, Idaho, Stati Uniti, 83864
        • Reclutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Sospeso
        • University of Illinois
      • Danville, Illinois, Stati Uniti, 61832
        • Reclutamento
        • Carle at The Riverfront
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Carle Physician Group-Effingham
        • Contatto:
        • Investigatore principale:
          • Pratima Chalasani
      • Mattoon, Illinois, Stati Uniti, 61938
        • Reclutamento
        • Carle Physician Group-Mattoon/Charleston
        • Contatto:
        • Investigatore principale:
          • Pratima Chalasani
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle BroMenn Medical Center
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
      • Normal, Illinois, Stati Uniti, 61761
        • Reclutamento
        • Carle Cancer Institute Normal
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
      • Urbana, Illinois, Stati Uniti, 61801
        • Reclutamento
        • Carle Cancer Center
        • Contatto:
        • Investigatore principale:
          • Pratima Chalasani
    • Indiana
      • Carmel, Indiana, Stati Uniti, 46032
        • Sospeso
        • IU Health North Hospital
      • Crown Point, Indiana, Stati Uniti, 46307
        • Reclutamento
        • Northwest Cancer Center - Crown Point
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
      • Dyer, Indiana, Stati Uniti, 46311
        • Reclutamento
        • Northwest Oncology LLC
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 219-924-8178
        • Investigatore principale:
          • Pratima Chalasani
      • Hobart, Indiana, Stati Uniti, 46342
        • Reclutamento
        • Northwest Cancer Center - Hobart
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 219-947-1795
        • Investigatore principale:
          • Pratima Chalasani
      • Hobart, Indiana, Stati Uniti, 46342
        • Reclutamento
        • Saint Mary Medical Center
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Reclutamento
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 317-278-5632
          • Email: iutrials@iu.edu
        • Investigatore principale:
          • Jessica E. Parker
      • Indianapolis, Indiana, Stati Uniti, 46312
        • Reclutamento
        • Saint Catherine Hospital
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
      • Munster, Indiana, Stati Uniti, 46321
        • Reclutamento
        • The Community Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 219-836-3349
        • Investigatore principale:
          • Pratima Chalasani
      • Munster, Indiana, Stati Uniti, 46321
        • Reclutamento
        • Women's Diagnostic Center - Munster
        • Contatto:
        • Investigatore principale:
          • Pratima Chalasani
      • Valparaiso, Indiana, Stati Uniti, 46383
        • Reclutamento
        • Northwest Cancer Center - Valparaiso
        • Investigatore principale:
          • Pratima Chalasani
        • Contatto:
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • Reclutamento
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-237-1225
        • Investigatore principale:
          • David P. Bender
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • Reclutamento
        • The James Graham Brown Cancer Center at University of Louisville
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 502-562-3429
        • Investigatore principale:
          • Jason A. Chesney
      • Louisville, Kentucky, Stati Uniti, 40245
        • Reclutamento
        • UofL Health Medical Center Northeast
        • Contatto:
        • Investigatore principale:
          • Jason A. Chesney
    • Maine
      • Scarborough, Maine, Stati Uniti, 04074
        • Reclutamento
        • MaineHealth Maine Medical Center- Scarborough
        • Investigatore principale:
          • Leslie S. Bradford
        • Contatto:
    • Michigan
      • Battle Creek, Michigan, Stati Uniti, 49017
        • Reclutamento
        • Bronson Battle Creek
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Sospeso
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Reclutamento
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Stati Uniti, 49007
        • Reclutamento
        • Bronson Methodist Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Stati Uniti, 49007
        • Reclutamento
        • West Michigan Cancer Center
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Stati Uniti, 49009
        • Reclutamento
        • Beacon Kalamazoo Cancer Center
        • Investigatore principale:
          • Kathleen Y. Butler
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 574-647-7370
      • Muskegon, Michigan, Stati Uniti, 49444
        • Sospeso
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Stati Uniti, 49120
        • Reclutamento
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 616-391-1230
        • Investigatore principale:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, Stati Uniti, 49444
        • Sospeso
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, Stati Uniti, 49677
        • Reclutamento
        • Corewell Health Reed City Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, Stati Uniti, 49085
        • Reclutamento
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, Stati Uniti, 49085
        • Reclutamento
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Traverse City, Michigan, Stati Uniti, 49684
        • Reclutamento
        • Munson Medical Center
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
      • Wyoming, Michigan, Stati Uniti, 49519
        • Reclutamento
        • University of Michigan Health - West
        • Contatto:
        • Investigatore principale:
          • Kathleen Y. Butler
    • Minnesota
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Reclutamento
        • Mercy Hospital
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Deer River, Minnesota, Stati Uniti, 56636
        • Reclutamento
        • Essentia Health - Deer River Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Duluth, Minnesota, Stati Uniti, 55805
        • Reclutamento
        • Essentia Health Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Duluth, Minnesota, Stati Uniti, 55805
        • Reclutamento
        • Miller-Dwan Hospital
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Fairview Southdale Hospital
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Minnesota Oncology - Edina
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Hibbing, Minnesota, Stati Uniti, 55746
        • Reclutamento
        • Essentia Health Hibbing Clinic
        • Investigatore principale:
          • Bret E. Friday
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 218-786-3308
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Reclutamento
        • Abbott-Northwestern Hospital
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Reclutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Reclutamento
        • Regions Hospital
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • Reclutamento
        • United Hospital
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Sandstone, Minnesota, Stati Uniti, 55072
        • Reclutamento
        • Essentia Health Sandstone
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Shakopee, Minnesota, Stati Uniti, 55379
        • Reclutamento
        • Saint Francis Regional Medical Center
        • Contatto:
        • Investigatore principale:
          • Adrianne Mallen
      • Virginia, Minnesota, Stati Uniti, 55792
        • Reclutamento
        • Essentia Health Virginia Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65212
        • Sospeso
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Washington University School of Medicine
        • Contatto:
        • Investigatore principale:
          • Premal H. Thaker
    • Montana
      • Anaconda, Montana, Stati Uniti, 59711
        • Reclutamento
        • Community Hospital of Anaconda
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59101
        • Reclutamento
        • Billings Clinic Cancer Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59102
        • Reclutamento
        • Saint Vincent Frontier Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-648-6274
        • Investigatore principale:
          • Megan Petersen
      • Billings, Montana, Stati Uniti, 59106
        • Reclutamento
        • Intermountain Health West End Clinic
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 406-238-6685
        • Investigatore principale:
          • Megan Petersen
      • Bozeman, Montana, Stati Uniti, 59715
        • Reclutamento
        • Bozeman Health Deaconess Hospital
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Great Falls, Montana, Stati Uniti, 59405
        • Reclutamento
        • Benefis Sletten Cancer Institute
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Kalispell, Montana, Stati Uniti, 59901
        • Reclutamento
        • Logan Health Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Missoula, Montana, Stati Uniti, 59804
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68114
        • Reclutamento
        • Nebraska Methodist Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 402-354-5144
        • Investigatore principale:
          • Brent J. Tierney
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Reclutamento
        • Women's Cancer Center of Nevada
        • Investigatore principale:
          • Nicola M. Spirtos
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 702-851-4672
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • Reclutamento
        • University of New Mexico Cancer Center
        • Contatto:
        • Investigatore principale:
          • Carolyn Y. Muller
    • New York
      • Buffalo, New York, Stati Uniti, 14263
        • Attivo, non reclutante
        • Roswell Park Cancer Institute
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 585-275-5830
        • Investigatore principale:
          • Rachael Turner
      • Syracuse, New York, Stati Uniti, 13210
        • Reclutamento
        • State University of New York Upstate Medical University
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 315-464-5476
        • Investigatore principale:
          • Mary J. Cunningham
      • Webster, New York, Stati Uniti, 14580
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Duke University Medical Center
        • Investigatore principale:
          • Angeles A. Secord
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 888-275-3853
      • Raleigh, North Carolina, Stati Uniti, 27607
        • Reclutamento
        • Duke Women's Cancer Care Raleigh
        • Investigatore principale:
          • Angeles A. Secord
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 919-785-4878
    • North Dakota
      • Fargo, North Dakota, Stati Uniti, 58103
        • Reclutamento
        • Essentia Health Cancer Center-South University Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
    • Ohio
      • Beachwood, Ohio, Stati Uniti, 44122
        • Reclutamento
        • UHHS-Chagrin Highlands Medical Center
        • Contatto:
        • Investigatore principale:
          • Amy Armstrong
      • Centerville, Ohio, Stati Uniti, 45459
        • Reclutamento
        • Miami Valley Hospital South
        • Contatto:
        • Investigatore principale:
          • Michael S. Guy
      • Chardon, Ohio, Stati Uniti, 44024
        • Reclutamento
        • Geauga Hospital
        • Contatto:
        • Investigatore principale:
          • Amy Armstrong
      • Cincinnati, Ohio, Stati Uniti, 45220
        • Attivo, non reclutante
        • Good Samaritan Hospital - Cincinnati
      • Cleveland, Ohio, Stati Uniti, 44195
        • Reclutamento
        • Cleveland Clinic Foundation
        • Contatto:
        • Investigatore principale:
          • Peter G. Rose
      • Cleveland, Ohio, Stati Uniti, 44106
        • Reclutamento
        • Case Western Reserve University
        • Contatto:
        • Investigatore principale:
          • Amy Armstrong
      • Cleveland, Ohio, Stati Uniti, 44111
        • Reclutamento
        • Cleveland Clinic Cancer Center/Fairview Hospital
        • Contatto:
        • Investigatore principale:
          • Peter G. Rose
      • Columbus, Ohio, Stati Uniti, 43210
        • Reclutamento
        • Ohio State University Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Floor Backes
      • Mayfield Heights, Ohio, Stati Uniti, 44124
        • Reclutamento
        • Hillcrest Hospital Cancer Center
        • Contatto:
        • Investigatore principale:
          • Peter G. Rose
      • Mentor, Ohio, Stati Uniti, 44060
        • Reclutamento
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • Contatto:
        • Investigatore principale:
          • Amy Armstrong
      • Parma, Ohio, Stati Uniti, 44129
        • Reclutamento
        • University Hospitals Parma Medical Center
        • Contatto:
        • Investigatore principale:
          • Amy Armstrong
      • Westlake, Ohio, Stati Uniti, 44145
        • Reclutamento
        • UH Seidman Cancer Center at Saint John Medical Center
        • Contatto:
        • Investigatore principale:
          • Amy Armstrong
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Christina Washington
      • Tulsa, Oklahoma, Stati Uniti, 74146
        • Attivo, non reclutante
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Ontario, Oregon, Stati Uniti, 97914
        • Sospeso
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Stati Uniti, 97213
        • Reclutamento
        • Providence Portland Medical Center
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Portland, Oregon, Stati Uniti, 97225
        • Reclutamento
        • Providence Saint Vincent Medical Center
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
    • Pennsylvania
      • Beaver, Pennsylvania, Stati Uniti, 15009
        • Reclutamento
        • UPMC-Heritage Valley Health System Beaver
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Butler, Pennsylvania, Stati Uniti, 16001
        • Reclutamento
        • UPMC Hillman Cancer Center at Butler Health System
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Cranberry Township, Pennsylvania, Stati Uniti, 16066
        • Reclutamento
        • UPMC Hillman Cancer Center - Passavant - Cranberry
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Erie, Pennsylvania, Stati Uniti, 16505
        • Reclutamento
        • UPMC Hillman Cancer Center Erie
        • Investigatore principale:
          • Alexander B. Olawaiye
        • Contatto:
      • Farrell, Pennsylvania, Stati Uniti, 16121
        • Reclutamento
        • UPMC Cancer Center at UPMC Horizon
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Greensburg, Pennsylvania, Stati Uniti, 15601
        • Reclutamento
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 724-838-1900
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Indiana, Pennsylvania, Stati Uniti, 15701
        • Reclutamento
        • IRMC Cancer Center
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Johnstown, Pennsylvania, Stati Uniti, 15901
        • Reclutamento
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 814-534-4724
        • Investigatore principale:
          • Alexander B. Olawaiye
      • McKeesport, Pennsylvania, Stati Uniti, 15132
        • Reclutamento
        • UPMC Cancer Center at UPMC McKeesport
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-647-8073
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Mechanicsburg, Pennsylvania, Stati Uniti, 17050
        • Reclutamento
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Monroeville, Pennsylvania, Stati Uniti, 15146
        • Reclutamento
        • UPMC Hillman Cancer Center - Monroeville
        • Investigatore principale:
          • Alexander B. Olawaiye
        • Contatto:
      • Moon Township, Pennsylvania, Stati Uniti, 15108
        • Reclutamento
        • UPMC Hillman Cancer Center in Coraopolis
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Mount Pleasant, Pennsylvania, Stati Uniti, 15666
        • Reclutamento
        • UPMC Hillman Cancer Center - Part of Frick Hospital
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • N. Huntingdon, Pennsylvania, Stati Uniti, 15642
        • Reclutamento
        • Arnold Palmer Cancer Center Medical Oncology Norwin
        • Investigatore principale:
          • Alexander B. Olawaiye
        • Contatto:
      • Natrona Heights, Pennsylvania, Stati Uniti, 15065
        • Reclutamento
        • UPMC Cancer Center-Natrona Heights
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 724-230-3030
        • Investigatore principale:
          • Alexander B. Olawaiye
      • New Castle, Pennsylvania, Stati Uniti, 16105
        • Reclutamento
        • UPMC Hillman Cancer Center - New Castle
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Reclutamento
        • UPMC-Magee Womens Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-647-2811
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, Stati Uniti, 15215
        • Reclutamento
        • UPMC-Saint Margaret
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-784-4900
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, Stati Uniti, 15219
        • Reclutamento
        • UPMC-Mercy Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-533-8762
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, Stati Uniti, 15237
        • Reclutamento
        • UPMC-Passavant Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-367-6454
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, Stati Uniti, 15243
        • Reclutamento
        • UPMC-Saint Clair Hospital Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-502-3920
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • Reclutamento
        • UPMC Hillman Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-647-8073
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Seneca, Pennsylvania, Stati Uniti, 16346
        • Reclutamento
        • UPMC Cancer Center at UPMC Northwest
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 814-676-7900
        • Investigatore principale:
          • Alexander B. Olawaiye
      • Washington, Pennsylvania, Stati Uniti, 15301
        • Reclutamento
        • UPMC Cancer Center-Washington
        • Contatto:
        • Investigatore principale:
          • Alexander B. Olawaiye
      • West Mifflin, Pennsylvania, Stati Uniti, 15122
        • Reclutamento
        • UPMC West Mifflin-Cancer Center Jefferson
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-653-8100
        • Investigatore principale:
          • Alexander B. Olawaiye
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02905
        • Reclutamento
        • Women and Infants Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 401-274-1122
        • Investigatore principale:
          • Cara A. Mathews
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contatto:
        • Investigatore principale:
          • David S. Miller
      • Dallas, Texas, Stati Uniti, 75235
        • Reclutamento
        • Parkland Memorial Hospital
        • Contatto:
        • Investigatore principale:
          • David S. Miller
      • Fort Worth, Texas, Stati Uniti, 76104
        • Sospeso
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, Stati Uniti, 75080
        • Reclutamento
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contatto:
        • Investigatore principale:
          • David S. Miller
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • Reclutamento
        • University of Virginia Cancer Center
        • Contatto:
        • Investigatore principale:
          • Linda R. Duska
      • Richmond, Virginia, Stati Uniti, 23229
        • Reclutamento
        • Henrico Doctor's Hospital
        • Investigatore principale:
          • Andrew S. Kennedy
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 804-591-4152
      • Richmond, Virginia, Stati Uniti, 23298
        • Attivo, non reclutante
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Edmonds, Washington, Stati Uniti, 98026
        • Reclutamento
        • Swedish Cancer Institute-Edmonds
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Issaquah, Washington, Stati Uniti, 98029
        • Reclutamento
        • Swedish Cancer Institute-Issaquah
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Seattle, Washington, Stati Uniti, 98122
        • Reclutamento
        • Swedish Medical Center-First Hill
        • Investigatore principale:
          • Dan S. Zuckerman
        • Contatto:
      • Seattle, Washington, Stati Uniti, 98109
        • Attivo, non reclutante
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Ashland, Wisconsin, Stati Uniti, 54806
        • Reclutamento
        • Duluth Clinic Ashland
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Ashland, Wisconsin, Stati Uniti, 54806
        • Reclutamento
        • Northwest Wisconsin Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: Ipilimumab

Given IV

Altri nomi:
  • Anticorpo monoclonale antigene-4 anti-citotossico associato ai linfociti T
  • BMS-734016
  • Ipilimumab biosimilare CS1002
  • MDX-010
  • MDX-CTLA4
  • Yevoy
  • MDX010
  • BMS734016
  • BMS 734016
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Biologico: Nivolumab

Given IV

Altri nomi:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab biosimilare CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab biosimilare ABP 206
  • BCD-263
  • Nivolumab biosimilare BCD-263
  • BMS936558
  • ONO4538
Procedura: Biospecimen Collection

Undergo collection of tissue and/or blood samples

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Comparatore attivo: 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.
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Biologico: Nivolumab

Given IV

Altri nomi:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab biosimilare CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab biosimilare ABP 206
  • BCD-263
  • Nivolumab biosimilare BCD-263
  • BMS936558
  • ONO4538
Procedura: Biospecimen Collection

Undergo collection of tissue and/or blood samples

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival (PFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Collaboratori

NRG Oncology

Investigatori

  • Investigatore principale: Haider S Mahdi, NRG Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 giugno 2022

Completamento primario (Stimato)

30 luglio 2032

Completamento dello studio (Stimato)

30 luglio 2032

Date di iscrizione allo studio

Primo inviato

6 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2021

Primo Inserito (Effettivo)

9 novembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2021-11881
  • U10CA180868 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2021-11881 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • NRG-GY025 (Altro identificatore: CTEP)
  • NRG-GY025 (Altro identificatore: NRG Oncology)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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