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Test du nivolumab avec ou sans ipilimumab dans le carcinome endométrial récurrent du système de réparation des mésappariements déficients (dMMR)

30 octobre 2026 mis à jour par: National Cancer Institute (NCI)

Un essai randomisé de phase II comparant le nivolumab et l'ipilimumab au nivolumab en monothérapie chez des patientes atteintes d'un carcinome de l'endomètre récidivant avec un système de réparation des mésappariements déficient

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

81

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Recrutement
        • University of Alabama at Birmingham Cancer Center
        • Chercheur principal:
          • Michael D. Toboni
        • Contact:
    • Georgia
      • Athens, Georgia, États-Unis, 30607
        • Suspendu
        • University Cancer and Blood Center LLC
      • Augusta, Georgia, États-Unis, 30912
        • Recrutement
        • Augusta University Medical Center
        • Contact:
        • Chercheur principal:
          • Bunja J. Rungruang
    • Idaho
      • Boise, Idaho, États-Unis, 83712
        • Recrutement
        • Saint Luke's Cancer Institute - Boise
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Boise, Idaho, États-Unis, 83706
        • Suspendu
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, États-Unis, 83605
        • Suspendu
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, États-Unis, 83814
        • Recrutement
        • Kootenai Health - Coeur d'Alene
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, États-Unis, 83619
        • Recrutement
        • Saint Luke's Cancer Institute - Fruitland
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Meridian, Idaho, États-Unis, 83642
        • Recrutement
        • Saint Luke's Cancer Institute - Meridian
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Nampa, Idaho, États-Unis, 83687
        • Recrutement
        • Saint Luke's Cancer Institute - Nampa
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Nampa, Idaho, États-Unis, 83687
        • Suspendu
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, États-Unis, 83854
        • Recrutement
        • Kootenai Clinic Cancer Services - Post Falls
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, États-Unis, 83864
        • Recrutement
        • Kootenai Clinic Cancer Services - Sandpoint
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Suspendu
        • University of Illinois
      • Danville, Illinois, États-Unis, 61832
        • Recrutement
        • Carle at The Riverfront
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
      • Effingham, Illinois, États-Unis, 62401
        • Recrutement
        • Carle Physician Group-Effingham
        • Contact:
        • Chercheur principal:
          • Pratima Chalasani
      • Mattoon, Illinois, États-Unis, 61938
        • Recrutement
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Chercheur principal:
          • Pratima Chalasani
      • Normal, Illinois, États-Unis, 61761
        • Recrutement
        • Carle BroMenn Medical Center
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
      • Normal, Illinois, États-Unis, 61761
        • Recrutement
        • Carle Cancer Institute Normal
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
      • Urbana, Illinois, États-Unis, 61801
        • Recrutement
        • Carle Cancer Center
        • Contact:
        • Chercheur principal:
          • Pratima Chalasani
    • Indiana
      • Carmel, Indiana, États-Unis, 46032
        • Suspendu
        • IU Health North Hospital
      • Crown Point, Indiana, États-Unis, 46307
        • Recrutement
        • Northwest Cancer Center - Crown Point
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
      • Dyer, Indiana, États-Unis, 46311
        • Recrutement
        • Northwest Oncology LLC
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 219-924-8178
        • Chercheur principal:
          • Pratima Chalasani
      • Hobart, Indiana, États-Unis, 46342
        • Recrutement
        • Northwest Cancer Center - Hobart
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 219-947-1795
        • Chercheur principal:
          • Pratima Chalasani
      • Hobart, Indiana, États-Unis, 46342
        • Recrutement
        • Saint Mary Medical Center
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
      • Indianapolis, Indiana, États-Unis, 46202
        • Recrutement
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 317-278-5632
          • E-mail: iutrials@iu.edu
        • Chercheur principal:
          • Jessica E. Parker
      • Indianapolis, Indiana, États-Unis, 46312
        • Recrutement
        • Saint Catherine Hospital
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
      • Munster, Indiana, États-Unis, 46321
        • Recrutement
        • The Community Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 219-836-3349
        • Chercheur principal:
          • Pratima Chalasani
      • Munster, Indiana, États-Unis, 46321
        • Recrutement
        • Women's Diagnostic Center - Munster
        • Contact:
        • Chercheur principal:
          • Pratima Chalasani
      • Valparaiso, Indiana, États-Unis, 46383
        • Recrutement
        • Northwest Cancer Center - Valparaiso
        • Chercheur principal:
          • Pratima Chalasani
        • Contact:
    • Iowa
      • Iowa City, Iowa, États-Unis, 52242
        • Recrutement
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-237-1225
        • Chercheur principal:
          • David P. Bender
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40202
        • Recrutement
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 502-562-3429
        • Chercheur principal:
          • Jason A. Chesney
      • Louisville, Kentucky, États-Unis, 40245
        • Recrutement
        • UofL Health Medical Center Northeast
        • Contact:
        • Chercheur principal:
          • Jason A. Chesney
    • Maine
      • Scarborough, Maine, États-Unis, 04074
        • Recrutement
        • MaineHealth Maine Medical Center- Scarborough
        • Chercheur principal:
          • Leslie S. Bradford
        • Contact:
    • Michigan
      • Battle Creek, Michigan, États-Unis, 49017
        • Recrutement
        • Bronson Battle Creek
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, États-Unis, 49503
        • Suspendu
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, États-Unis, 49503
        • Recrutement
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, États-Unis, 49007
        • Recrutement
        • Bronson Methodist Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, États-Unis, 49007
        • Recrutement
        • West Michigan Cancer Center
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, États-Unis, 49009
        • Recrutement
        • Beacon Kalamazoo Cancer Center
        • Chercheur principal:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 574-647-7370
      • Muskegon, Michigan, États-Unis, 49444
        • Suspendu
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, États-Unis, 49120
        • Recrutement
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 616-391-1230
        • Chercheur principal:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, États-Unis, 49444
        • Suspendu
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, États-Unis, 49677
        • Recrutement
        • Corewell Health Reed City Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, États-Unis, 49085
        • Recrutement
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, États-Unis, 49085
        • Recrutement
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Traverse City, Michigan, États-Unis, 49684
        • Recrutement
        • Munson Medical Center
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Wyoming, Michigan, États-Unis, 49519
        • Recrutement
        • University of Michigan Health - West
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
    • Minnesota
      • Coon Rapids, Minnesota, États-Unis, 55433
        • Recrutement
        • Mercy Hospital
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Deer River, Minnesota, États-Unis, 56636
        • Recrutement
        • Essentia Health - Deer River Clinic
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
      • Duluth, Minnesota, États-Unis, 55805
        • Recrutement
        • Essentia Health Cancer Center
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
      • Duluth, Minnesota, États-Unis, 55805
        • Recrutement
        • Miller-Dwan Hospital
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
      • Edina, Minnesota, États-Unis, 55435
        • Recrutement
        • Fairview Southdale Hospital
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Edina, Minnesota, États-Unis, 55435
        • Recrutement
        • Minnesota Oncology - Edina
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Hibbing, Minnesota, États-Unis, 55746
        • Recrutement
        • Essentia Health Hibbing Clinic
        • Chercheur principal:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 218-786-3308
      • Minneapolis, Minnesota, États-Unis, 55407
        • Recrutement
        • Abbott-Northwestern Hospital
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Saint Louis Park, Minnesota, États-Unis, 55416
        • Recrutement
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Saint Paul, Minnesota, États-Unis, 55101
        • Recrutement
        • Regions Hospital
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Saint Paul, Minnesota, États-Unis, 55102
        • Recrutement
        • United Hospital
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Sandstone, Minnesota, États-Unis, 55072
        • Recrutement
        • Essentia Health Sandstone
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
      • Shakopee, Minnesota, États-Unis, 55379
        • Recrutement
        • Saint Francis Regional Medical Center
        • Contact:
        • Chercheur principal:
          • Adrianne Mallen
      • Virginia, Minnesota, États-Unis, 55792
        • Recrutement
        • Essentia Health Virginia Clinic
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
    • Missouri
      • Columbia, Missouri, États-Unis, 65212
        • Recrutement
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 573-882-7440
        • Chercheur principal:
          • Arwa M. Mohammad
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University School of Medicine
        • Contact:
        • Chercheur principal:
          • Premal H. Thaker
    • Montana
      • Anaconda, Montana, États-Unis, 59711
        • Recrutement
        • Community Hospital of Anaconda
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, États-Unis, 59101
        • Recrutement
        • Billings Clinic Cancer Center
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, États-Unis, 59102
        • Recrutement
        • Saint Vincent Frontier Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-648-6274
        • Chercheur principal:
          • Megan Petersen
      • Billings, Montana, États-Unis, 59106
        • Recrutement
        • Intermountain Health West End Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 406-238-6685
        • Chercheur principal:
          • Megan Petersen
      • Bozeman, Montana, États-Unis, 59715
        • Recrutement
        • Bozeman Health Deaconess Hospital
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, États-Unis, 59405
        • Recrutement
        • Benefis Sletten Cancer Institute
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, États-Unis, 59901
        • Recrutement
        • Logan Health Medical Center
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, États-Unis, 59804
        • Recrutement
        • Community Medical Center
        • Chercheur principal:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68114
        • Recrutement
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 402-354-5144
        • Chercheur principal:
          • Brent J. Tierney
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89106
        • Recrutement
        • Women's Cancer Center of Nevada
        • Chercheur principal:
          • Nicola M. Spirtos
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 702-851-4672
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87106
        • Recrutement
        • University of New Mexico Cancer Center
        • Contact:
        • Chercheur principal:
          • Carolyn Y. Muller
    • New York
      • Buffalo, New York, États-Unis, 14263
        • Actif, ne recrute pas
        • Roswell Park Cancer Institute
      • Rochester, New York, États-Unis, 14642
        • Recrutement
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 585-275-5830
        • Chercheur principal:
          • Rachael Turner
      • Syracuse, New York, États-Unis, 13210
        • Recrutement
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 315-464-5476
        • Chercheur principal:
          • Mary J. Cunningham
      • Webster, New York, États-Unis, 14580
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Recrutement
        • Duke University Medical Center
        • Chercheur principal:
          • Angeles A. Secord
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 888-275-3853
      • Raleigh, North Carolina, États-Unis, 27607
        • Recrutement
        • Duke Women's Cancer Care Raleigh
        • Chercheur principal:
          • Angeles A. Secord
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 919-785-4878
    • North Dakota
      • Fargo, North Dakota, États-Unis, 58103
        • Recrutement
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
    • Ohio
      • Beachwood, Ohio, États-Unis, 44122
        • Recrutement
        • UHHS-Chagrin Highlands Medical Center
        • Contact:
        • Chercheur principal:
          • Amy Armstrong
      • Centerville, Ohio, États-Unis, 45459
        • Recrutement
        • Miami Valley Hospital South
        • Contact:
        • Chercheur principal:
          • Michael S. Guy
      • Chardon, Ohio, États-Unis, 44024
        • Recrutement
        • Geauga Hospital
        • Contact:
        • Chercheur principal:
          • Amy Armstrong
      • Cincinnati, Ohio, États-Unis, 45220
        • Actif, ne recrute pas
        • Good Samaritan Hospital - Cincinnati
      • Cleveland, Ohio, États-Unis, 44195
        • Recrutement
        • Cleveland Clinic Foundation
        • Contact:
        • Chercheur principal:
          • Peter G. Rose
      • Cleveland, Ohio, États-Unis, 44106
        • Recrutement
        • Case Western Reserve University
        • Contact:
        • Chercheur principal:
          • Amy Armstrong
      • Cleveland, Ohio, États-Unis, 44111
        • Recrutement
        • Cleveland Clinic Cancer Center/Fairview Hospital
        • Contact:
        • Chercheur principal:
          • Peter G. Rose
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Floor Backes
      • Mayfield Heights, Ohio, États-Unis, 44124
        • Recrutement
        • Hillcrest Hospital Cancer Center
        • Contact:
        • Chercheur principal:
          • Peter G. Rose
      • Mentor, Ohio, États-Unis, 44060
        • Recrutement
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • Contact:
        • Chercheur principal:
          • Amy Armstrong
      • Parma, Ohio, États-Unis, 44129
        • Recrutement
        • University Hospitals Parma Medical Center
        • Contact:
        • Chercheur principal:
          • Amy Armstrong
      • Westlake, Ohio, États-Unis, 44145
        • Recrutement
        • UH Seidman Cancer Center at Saint John Medical Center
        • Contact:
        • Chercheur principal:
          • Amy Armstrong
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Recrutement
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Chercheur principal:
          • Christina Washington
      • Tulsa, Oklahoma, États-Unis, 74146
        • Actif, ne recrute pas
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Ontario, Oregon, États-Unis, 97914
        • Suspendu
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, États-Unis, 97213
        • Recrutement
        • Providence Portland Medical Center
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, États-Unis, 97225
        • Recrutement
        • Providence Saint Vincent Medical Center
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
    • Pennsylvania
      • Beaver, Pennsylvania, États-Unis, 15009
        • Recrutement
        • UPMC-Heritage Valley Health System Beaver
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Butler, Pennsylvania, États-Unis, 16001
        • Recrutement
        • UPMC Hillman Cancer Center at Butler Health System
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Cranberry Township, Pennsylvania, États-Unis, 16066
        • Recrutement
        • UPMC Hillman Cancer Center - Passavant - Cranberry
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Erie, Pennsylvania, États-Unis, 16505
        • Recrutement
        • UPMC Hillman Cancer Center Erie
        • Chercheur principal:
          • Alexander B. Olawaiye
        • Contact:
      • Farrell, Pennsylvania, États-Unis, 16121
        • Recrutement
        • UPMC Cancer Center at UPMC Horizon
        • Contact:
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Greensburg, Pennsylvania, États-Unis, 15601
        • Recrutement
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 724-838-1900
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Indiana, Pennsylvania, États-Unis, 15701
        • Recrutement
        • IRMC Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Johnstown, Pennsylvania, États-Unis, 15901
        • Recrutement
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 814-534-4724
        • Chercheur principal:
          • Alexander B. Olawaiye
      • McKeesport, Pennsylvania, États-Unis, 15132
        • Recrutement
        • UPMC Cancer Center at UPMC McKeesport
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-647-8073
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Mechanicsburg, Pennsylvania, États-Unis, 17050
        • Recrutement
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Monroeville, Pennsylvania, États-Unis, 15146
        • Recrutement
        • UPMC Hillman Cancer Center - Monroeville
        • Chercheur principal:
          • Alexander B. Olawaiye
        • Contact:
      • Moon Township, Pennsylvania, États-Unis, 15108
        • Recrutement
        • UPMC Hillman Cancer Center in Coraopolis
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Mount Pleasant, Pennsylvania, États-Unis, 15666
        • Recrutement
        • UPMC Hillman Cancer Center - Part of Frick Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • N. Huntingdon, Pennsylvania, États-Unis, 15642
        • Recrutement
        • Arnold Palmer Cancer Center Medical Oncology Norwin
        • Chercheur principal:
          • Alexander B. Olawaiye
        • Contact:
      • Natrona Heights, Pennsylvania, États-Unis, 15065
        • Recrutement
        • UPMC Cancer Center-Natrona Heights
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 724-230-3030
        • Chercheur principal:
          • Alexander B. Olawaiye
      • New Castle, Pennsylvania, États-Unis, 16105
        • Recrutement
        • UPMC Hillman Cancer Center - New Castle
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-389-5208
          • E-mail: haneydl@upmc.edu
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Recrutement
        • UPMC-Magee Womens Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-647-2811
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, États-Unis, 15215
        • Recrutement
        • UPMC-Saint Margaret
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-784-4900
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, États-Unis, 15219
        • Recrutement
        • UPMC-Mercy Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-533-8762
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, États-Unis, 15237
        • Recrutement
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-367-6454
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, États-Unis, 15243
        • Recrutement
        • UPMC-Saint Clair Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-502-3920
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • Recrutement
        • UPMC Hillman Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-647-8073
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Seneca, Pennsylvania, États-Unis, 16346
        • Recrutement
        • UPMC Cancer Center at UPMC Northwest
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 814-676-7900
        • Chercheur principal:
          • Alexander B. Olawaiye
      • Washington, Pennsylvania, États-Unis, 15301
        • Recrutement
        • UPMC Cancer Center-Washington
        • Contact:
        • Chercheur principal:
          • Alexander B. Olawaiye
      • West Mifflin, Pennsylvania, États-Unis, 15122
        • Recrutement
        • UPMC West Mifflin-Cancer Center Jefferson
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-653-8100
        • Chercheur principal:
          • Alexander B. Olawaiye
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02905
        • Recrutement
        • Women and Infants Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 401-274-1122
        • Chercheur principal:
          • Cara A. Mathews
    • Texas
      • Dallas, Texas, États-Unis, 75390
        • Recrutement
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Chercheur principal:
          • David S. Miller
      • Dallas, Texas, États-Unis, 75235
        • Recrutement
        • Parkland Memorial Hospital
        • Contact:
        • Chercheur principal:
          • David S. Miller
      • Fort Worth, Texas, États-Unis, 76104
        • Suspendu
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, États-Unis, 75080
        • Recrutement
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Chercheur principal:
          • David S. Miller
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22908
        • Recrutement
        • University of Virginia Cancer Center
        • Contact:
        • Chercheur principal:
          • Linda R. Duska
      • Richmond, Virginia, États-Unis, 23229
        • Recrutement
        • Henrico Doctor's Hospital
        • Chercheur principal:
          • Andrew S. Kennedy
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 804-591-4152
      • Richmond, Virginia, États-Unis, 23298
        • Actif, ne recrute pas
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Edmonds, Washington, États-Unis, 98026
        • Recrutement
        • Swedish Cancer Institute-Edmonds
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Issaquah, Washington, États-Unis, 98029
        • Recrutement
        • Swedish Cancer Institute-Issaquah
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Seattle, Washington, États-Unis, 98122
        • Recrutement
        • Swedish Medical Center-First Hill
        • Chercheur principal:
          • Dan S. Zuckerman
        • Contact:
      • Seattle, Washington, États-Unis, 98109
        • Actif, ne recrute pas
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Ashland, Wisconsin, États-Unis, 54806
        • Recrutement
        • Duluth Clinic Ashland
        • Contact:
        • Chercheur principal:
          • Bret E. Friday
      • Ashland, Wisconsin, États-Unis, 54806
        • Recrutement
        • Northwest Wisconsin Cancer Center
        • Contact:
        • Chercheur principal:
          • Bret E. Friday

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: Ipilimumab

Given IV

Autres noms:
  • Anti-Anticorps Monoclonal Antigène-4 Associé aux Lymphocytes T Cytotoxiques
  • BMS-734016
  • Ipilimumab biosimilaire CS1002
  • MDX-010
  • MDX-CTLA4
  • Yervoy
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
Procédure: Computed Tomography

Undergo CT

Autres noms:
  • TDM
  • CHAT
  • Scanner
  • Tomographie axiale informatisée
  • Tomographie assistée par ordinateur
  • Tomodensitométrie
  • tomographie
  • Tomographie axiale informatisée (procédure)
  • Tomodensitométrie (TDM)
  • Scan de chat diagnostique
  • Type de service de scan de chat diagnostique
Procédure: Magnetic Resonance Imaging

Undergo MRI

Autres noms:
  • IRM
  • Résonance magnétique
  • Balayage d'imagerie par résonance magnétique
  • Imagerie Médicale, Résonance Magnétique / Résonance Magnétique Nucléaire
  • M
  • Imagerie IRM
  • Imagerie RMN
  • NMRI
  • Imagerie par résonance magnétique nucléaire
  • Imagerie par résonance magnétique (IRM)
  • IRMs
  • Imagerie par résonance magnétique (procédure)
  • IRM structurelle
Biologique: Nivolumab

Given IV

Autres noms:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab biosimilaire CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • PAS 206
  • Nivolumab Biosimilaire ABP 206
  • BCD-263
  • Nivolumab biosimilaire BCD-263
  • BMS936558
  • ONO4538
Procédure: Biospecimen Collection

Undergo collection of tissue and/or blood samples

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Comparateur actif: 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.
Procédure: Computed Tomography

Undergo CT

Autres noms:
  • TDM
  • CHAT
  • Scanner
  • Tomographie axiale informatisée
  • Tomographie assistée par ordinateur
  • Tomodensitométrie
  • tomographie
  • Tomographie axiale informatisée (procédure)
  • Tomodensitométrie (TDM)
  • Scan de chat diagnostique
  • Type de service de scan de chat diagnostique
Procédure: Magnetic Resonance Imaging

Undergo MRI

Autres noms:
  • IRM
  • Résonance magnétique
  • Balayage d'imagerie par résonance magnétique
  • Imagerie Médicale, Résonance Magnétique / Résonance Magnétique Nucléaire
  • M
  • Imagerie IRM
  • Imagerie RMN
  • NMRI
  • Imagerie par résonance magnétique nucléaire
  • Imagerie par résonance magnétique (IRM)
  • IRMs
  • Imagerie par résonance magnétique (procédure)
  • IRM structurelle
Biologique: Nivolumab

Given IV

Autres noms:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab biosimilaire CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • PAS 206
  • Nivolumab Biosimilaire ABP 206
  • BCD-263
  • Nivolumab biosimilaire BCD-263
  • BMS936558
  • ONO4538
Procédure: Biospecimen Collection

Undergo collection of tissue and/or blood samples

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free survival (PFS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall survival (OS)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Cancer Institute (NCI)

Collaborateurs

NRG Oncology

Les enquêteurs

  • Chercheur principal: Haider S Mahdi, NRG Oncology

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2022

Achèvement primaire (Estimé)

30 juillet 2032

Achèvement de l'étude (Estimé)

30 juillet 2032

Dates d'inscription aux études

Première soumission

6 novembre 2021

Première soumission répondant aux critères de contrôle qualité

6 novembre 2021

Première publication (Réel)

9 novembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2021-11881
  • U10CA180868 (Subvention/contrat des NIH des États-Unis)
  • NCI-2021-11881 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • NRG-GY025 (Autre identifiant: CTEP)
  • NRG-GY025 (Autre identifiant: NRG Oncology)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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