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Nivolumab testen met of zonder ipilimumab in Deficient Mismatch Repair System (dMMR) Recidiverend endometriumcarcinoom

3 november 2026 bijgewerkt door: National Cancer Institute (NCI)

Een gerandomiseerde fase II-studie van nivolumab en ipilimumab vergeleken met monotherapie met nivolumab bij patiënten met een deficiënt mismatch-reparatiesysteem Recidiverend endometriumcarcinoom

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

81

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: Ipilimumab

Given IV

Andere namen:
  • Anti-cytotoxisch T-lymfocyt-geassocieerd antigeen-4 monoklonaal antilichaam
  • BMS-734016
  • Ipilimumab Biosimilar CS1002
  • MDX-010
  • MDX-CTLA4
  • Yervoy
  • MDX010
  • BMS734016
  • GBS 734016
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Biologisch: Nivolumab

Given IV

Andere namen:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Optie
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • GBS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Procedure: Biospecimen Collection

Undergo collection of tissue and/or blood samples

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Actieve vergelijker: 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.
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Biologisch: Nivolumab

Given IV

Andere namen:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Optie
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • GBS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Procedure: Biospecimen Collection

Undergo collection of tissue and/or blood samples

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free survival (PFS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Medewerkers

NRG Oncology

Onderzoekers

  • Hoofdonderzoeker: Haider S Mahdi, NRG Oncology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juni 2022

Primaire voltooiing (Geschat)

30 juli 2032

Studie voltooiing (Geschat)

30 juli 2032

Studieregistratiedata

Eerst ingediend

6 november 2021

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2021

Eerst geplaatst (Werkelijk)

9 november 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2021-11881
  • U10CA180868 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2021-11881 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • NRG-GY025 (Andere identificatie: CTEP)
  • NRG-GY025 (Andere identificatie: NRG Oncology)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren