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Anti-Lag-3 (Relatlinib) og Anti-PD-1 blokade (Nivolumab) versus standardbehandling (Lomustine) for behandling av pasienter med tilbakevendende glioblastom

31. oktober 2026 oppdatert av: National Cancer Institute (NCI)

Randomisert fase II-studie av anti-lag-3 og anti-PD-1-blokkade vs. SOC hos pasienter med tilbakevendende glioblastom

This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill tumor cells. Giving relatlimab and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.

Studieoversikt

Status

Suspendert

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVE:

I. To compare the restricted mean survival time (RMST) for overall survival (OS) between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care chloroethylcyclohexylnitrosourea (CCNU) (lomustine).

SECONDARY OBJECTIVES:

I. To compare the 12-month OS rates between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).

II. To compare the restricted mean survival times for progression-free survival (PFS) between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).

III. To compare the radiographic response rate between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).

IV. To compare the safety/adverse event rate between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes followed by relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, magnetic resonance imaging (MRI), and blood sample collection throughout study.

ARM II: Patients receive lomustine orally (PO) on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study.

After completion of study treatment, patients are followed up every 6 months for up to 5 years from time of randomization.

Studietype

Intervensjonell

Registrering (Antatt)

184

Fase

  • Fase 2

Kontakter og plasseringer

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Studiesteder

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    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Auburn, California, Forente stater, 95602
        • Sutter Auburn Faith Hospital
      • Duarte, California, Forente stater, 91010
        • City of Hope Comprehensive Cancer Center
      • Dublin, California, Forente stater, 94568
        • Kaiser Permanente Dublin
      • Fremont, California, Forente stater, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, Forente stater, 93720
        • Kaiser Permanente Fresno Orchard Plaza
      • Irvine, California, Forente stater, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • La Jolla, California, Forente stater, 92093
        • UC San Diego Moores Cancer Center
      • Lancaster, California, Forente stater, 93534
        • City of Hope Antelope Valley
      • Long Beach, California, Forente stater, 90813
        • City of Hope at Long Beach Elm
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forente stater, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Modesto, California, Forente stater, 95356
        • Kaiser Permanente-Modesto
      • Modesto, California, Forente stater, 95356
        • Kaiser Permanente- Modesto MOB II
      • Oakland, California, Forente stater, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, Forente stater, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Forente stater, 94304
        • Stanford Cancer Institute Palo Alto
      • Palo Alto, California, Forente stater, 94301
        • Palo Alto Medical Foundation Health Care
      • Redwood City, California, Forente stater, 94063
        • Kaiser Permanente- Marshall Medical Offices
      • Roseville, California, Forente stater, 95661
        • Kaiser Permanente-Roseville
      • Roseville, California, Forente stater, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, Forente stater, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Forente stater, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, Forente stater, 95823
        • Kaiser Permanente-South Sacramento
      • San Diego, California, Forente stater, 92120
        • Kaiser Permanente-San Diego Zion
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        • Kaiser Permanente-San Francisco
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        • California Pacific Medical Center-Pacific Campus
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        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, Forente stater, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, Forente stater, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, Forente stater, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, Forente stater, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, Forente stater, 94080
        • Kaiser Permanente-South San Francisco
      • Upland, California, Forente stater, 91786
        • City of Hope Upland
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        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, Forente stater, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, Forente stater, 94598
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    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80909
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        • Kaiser Permanente-Franklin
      • Fort Collins, Colorado, Forente stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forente stater, 80528
        • Cancer Care and Hematology-Fort Collins
      • Greeley, Colorado, Forente stater, 80631
        • UCHealth Greeley Hospital
      • Lafayette, Colorado, Forente stater, 80026
        • Kaiser Permanente-Rock Creek
      • Loveland, Colorado, Forente stater, 80538
        • Medical Center of the Rockies
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06606
        • Hartford HealthCare - Saint Vincent's Medical Center
      • Hartford, Connecticut, Forente stater, 06102
        • Hartford Hospital
      • New Haven, Connecticut, Forente stater, 06520
        • Yale University
      • Trumbull, Connecticut, Forente stater, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
    • Delaware
      • Millville, Delaware, Forente stater, 19967
        • Beebe South Coastal Health Campus
      • Newark, Delaware, Forente stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forente stater, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, Forente stater, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20016
        • Sibley Memorial Hospital
    • Florida
      • Aventura, Florida, Forente stater, 33180
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, Forente stater, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Coral Springs, Florida, Forente stater, 33065
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
      • Deerfield Beach, Florida, Forente stater, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Doral, Florida, Forente stater, 33166
        • UM Sylvester Comprehensive Cancer Center at Doral
      • Gainesville, Florida, Forente stater, 32610
        • UF Health Cancer Institute - Gainesville
      • Hollywood, Florida, Forente stater, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Hollywood, Florida, Forente stater, 33021
        • UM Sylvester Comprehensive Cancer Center at Hollywood
      • Jacksonville, Florida, Forente stater, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, Forente stater, 32224-9980
        • Mayo Clinic in Florida
      • Miami, Florida, Forente stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Forente stater, 33176
        • Miami Cancer Institute
      • Miami, Florida, Forente stater, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Orlando, Florida, Forente stater, 32806
        • Orlando Health Cancer Institute
      • Plantation, Florida, Forente stater, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • Augusta University Medical Center
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      • Honolulu, Hawaii, Forente stater, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, Forente stater, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, Forente stater, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Forente stater, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, Forente stater, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Forente stater, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Forente stater, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, Forente stater, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, Forente stater, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, Forente stater, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
    • Illinois
      • Aurora, Illinois, Forente stater, 60506
        • Advocate Outpatient Center - Aurora
      • Barrington, Illinois, Forente stater, 60010
        • Advocate Good Shepherd Hospital
      • Bloomington, Illinois, Forente stater, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Forente stater, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Forente stater, 62321
        • Illinois CancerCare-Carthage
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forente stater, 60657
        • Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, Forente stater, 60612
        • Rush MD Anderson Cancer Center
      • Crystal Lake, Illinois, Forente stater, 60014
        • AMG Crystal Lake - Oncology
      • Decatur, Illinois, Forente stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forente stater, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, Forente stater, 61021
        • Illinois CancerCare-Dixon
      • Downers Grove, Illinois, Forente stater, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, Forente stater, 62401
        • Crossroads Cancer Center
      • Elgin, Illinois, Forente stater, 60123
        • Advocate Sherman Hospital
      • Eureka, Illinois, Forente stater, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Forente stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Forente stater, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Hazel Crest, Illinois, Forente stater, 60429
        • Advocate South Suburban Hospital
      • Kewanee, Illinois, Forente stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, Forente stater, 60048
        • Condell Memorial Hospital
      • Libertyville, Illinois, Forente stater, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, Forente stater, 61455
        • Illinois CancerCare-Macomb
      • O'Fallon, Illinois, Forente stater, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, Forente stater, 62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Lawn, Illinois, Forente stater, 60453-2699
        • Advocate Christ Medical Center
      • Oak Lawn, Illinois, Forente stater, 60453
        • Advocate Outpatient Center - Oak Lawn
      • Ottawa, Illinois, Forente stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Palos Heights, Illinois, Forente stater, 60463
        • Advocate High Tech Medical Park
      • Park Ridge, Illinois, Forente stater, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, Forente stater, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Forente stater, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Forente stater, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Forente stater, 61356
        • Illinois CancerCare-Princeton
      • Shiloh, Illinois, Forente stater, 62269
        • Memorial Hospital East
      • Springfield, Illinois, Forente stater, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Forente stater, 62702
        • Springfield Clinic
      • Springfield, Illinois, Forente stater, 62781
        • Springfield Memorial Hospital
      • Washington, Illinois, Forente stater, 61571
        • Illinois CancerCare - Washington
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46237
        • Franciscan Health Indianapolis
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Forente stater, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, Forente stater, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Bettendorf, Iowa, Forente stater, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Boone, Iowa, Forente stater, 50036
        • McFarland Clinic - Boone
      • Carroll, Iowa, Forente stater, 51401
        • Saint Anthony Regional Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, Forente stater, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, Forente stater, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Forente stater, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Fort Dodge, Iowa, Forente stater, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Fort Dodge, Iowa, Forente stater, 50501
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, Forente stater, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forente stater, 50158
        • McFarland Clinic - Marshalltown
      • Waukee, Iowa, Forente stater, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, Forente stater, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, Forente stater, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Westwood, Kansas, Forente stater, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Forente stater, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Maine
      • Brewer, Maine, Forente stater, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, Forente stater, 04074
        • MaineHealth Maine Medical Center- Scarborough
      • South Portland, Maine, Forente stater, 04106
        • MaineHealth Cancer Care and IV Therapy - South Portland
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, Forente stater, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, Forente stater, 48116
        • University of Michigan - Brighton Center for Specialty Care
      • Canton, Michigan, Forente stater, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Chelsea, Michigan, Forente stater, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Escanaba, Michigan, Forente stater, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Flint, Michigan, Forente stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forente stater, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Forente stater, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, Forente stater, 48503
        • Cancer Hematology Centers - Flint
      • Lansing, Michigan, Forente stater, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Forente stater, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Ypsilanti, Michigan, Forente stater, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Bemidji, Minnesota, Forente stater, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, Forente stater, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy Hospital
      • Deer River, Minnesota, Forente stater, 56636
        • Essentia Health - Deer River Clinic
      • Duluth, Minnesota, Forente stater, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Hibbing, Minnesota, Forente stater, 55746
        • Essentia Health Hibbing Clinic
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott-Northwestern Hospital
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forente stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Sandstone, Minnesota, Forente stater, 55072
        • Essentia Health Sandstone
      • Virginia, Minnesota, Forente stater, 55792
        • Essentia Health Virginia Clinic
    • Mississippi
      • Columbus, Mississippi, Forente stater, 39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Grenada, Mississippi, Forente stater, 38901
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, Forente stater, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, Forente stater, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, Forente stater, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Saint Francis Medical Center
      • City of Saint Peters, Missouri, Forente stater, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Forente stater, 63141
        • Siteman Cancer Center at West County Hospital
      • St Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forente stater, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Forente stater, 63136
        • Siteman Cancer Center at Christian Hospital
      • St Louis, Missouri, Forente stater, 63128
        • Mercy Hospital South
    • Montana
      • Anaconda, Montana, Forente stater, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Forente stater, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Forente stater, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Forente stater, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, Forente stater, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Forente stater, 59804
        • Community Medical Center
    • Nebraska
      • Bellevue, Nebraska, Forente stater, 68123
        • Nebraska Medicine-Bellevue
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        • University of Nebraska Medical Center
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        • Nebraska Medicine-Village Pointe
    • Nevada
      • Reno, Nevada, Forente stater, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cooper Hospital University Medical Center
      • Edison, New Jersey, Forente stater, 08818
        • John F Kennedy Medical Center
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
      • Jersey City, New Jersey, Forente stater, 07302
        • Jersey City Medical Center
      • Livingston, New Jersey, Forente stater, 07039
        • Cooperman Barnabas Medical Center
      • Long Branch, New Jersey, Forente stater, 07740
        • Monmouth Medical Center
      • Morristown, New Jersey, Forente stater, 07960
        • Morristown Medical Center
      • Neptune City, New Jersey, Forente stater, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, Forente stater, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, Forente stater, 07112
        • Newark Beth Israel Medical Center
      • Sewell, New Jersey, Forente stater, 08080
        • Sidney Kimmel Cancer Center Washington Township
      • Summit, New Jersey, Forente stater, 07902
        • Overlook Hospital
      • Toms River, New Jersey, Forente stater, 08755
        • Community Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, Forente stater, 87110
        • Presbyterian Kaseman Hospital
      • Rio Rancho, New Mexico, Forente stater, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
    • New York
      • Bay Shore, New York, Forente stater, 11706
        • Northwell Health Imbert Cancer Center
      • Brooklyn, New York, Forente stater, 11220
        • NYU Langone Hospital - Brooklyn
      • Buffalo, New York, Forente stater, 14263
        • Roswell Park Cancer Institute
      • Glens Falls, New York, Forente stater, 12801
        • Glens Falls Hospital
      • Lake Success, New York, Forente stater, 11042
        • Northwell Health/Center for Advanced Medicine
      • Mineola, New York, Forente stater, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, Forente stater, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Forente stater, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Oswego, New York, Forente stater, 13126
        • Upstate Cancer Center at Oswego
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
      • Syracuse, New York, Forente stater, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Forente stater, 10461
        • Montefiore Medical Center-Einstein Campus
    • North Carolina
      • Pinehurst, North Carolina, Forente stater, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Forente stater, 58103
        • Essentia Health Cancer Center-South University Clinic
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Centerville, Ohio, Forente stater, 45459
        • Miami Valley Hospital South
      • Cincinnati, Ohio, Forente stater, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Forente stater, 45220
        • Good Samaritan Hospital - Cincinnati
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forente stater, 45409
        • Premier Blood and Cancer Center
      • Franklin, Ohio, Forente stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Forente stater, 45331
        • Miami Valley Cancer Care and Infusion
      • Troy, Ohio, Forente stater, 45373
        • Upper Valley Medical Center
      • West Chester, Ohio, Forente stater, 45069
        • University of Cincinnati Cancer Center-West Chester
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Gresham, Oregon, Forente stater, 97030
        • Legacy Mount Hood Medical Center
      • Ontario, Oregon, Forente stater, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Forente stater, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97225
        • Providence Saint Vincent Medical Center
      • Tualatin, Oregon, Forente stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forente stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • East Stroudsburg, Pennsylvania, Forente stater, 18301
        • Pocono Medical Center
      • Erie, Pennsylvania, Forente stater, 16505
        • UPMC Hillman Cancer Center Erie
      • Erie, Pennsylvania, Forente stater, 16544
        • Saint Vincent Hospital
      • Jefferson Hills, Pennsylvania, Forente stater, 15025
        • Jefferson Hospital
      • Monroeville, Pennsylvania, Forente stater, 15146
        • Forbes Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • UPMC Hillman Cancer Center
      • Wexford, Pennsylvania, Forente stater, 15090
        • Wexford Health and Wellness Pavilion
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forente stater, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Collierville, Tennessee, Forente stater, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Memphis, Tennessee, Forente stater, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Forente stater, 05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Inova Schar Cancer Institute
      • Mechanicsville, Virginia, Forente stater, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, Forente stater, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, Forente stater, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, Forente stater, 23223
        • Bon Secours Richmond Community Hospital
      • Richmond, Virginia, Forente stater, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, Forente stater, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Vancouver, Washington, Forente stater, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Forente stater, 98684
        • Legacy Cancer Institute Medical Oncology and Day Treatment
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, Forente stater, 26101
        • Camden Clark Medical Center
      • Wheeling, West Virginia, Forente stater, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Ashland, Wisconsin, Forente stater, 54806
        • Duluth Clinic Ashland
      • Burlington, Wisconsin, Forente stater, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Cudahy, Wisconsin, Forente stater, 53110
        • Aurora Saint Luke's South Shore
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Germantown, Wisconsin, Forente stater, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Forente stater, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Forente stater, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, Forente stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forente stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Janesville, Wisconsin, Forente stater, 53548
        • Mercyhealth Hospital and Cancer Center - Janesville
      • Kenosha, Wisconsin, Forente stater, 53142
        • Aurora Cancer Care-Kenosha South
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Forente stater, 53718
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marinette, Wisconsin, Forente stater, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Forente stater, 53233
        • Aurora Sinai Medical Center
      • Mukwonago, Wisconsin, Forente stater, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, Forente stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Oshkosh, Wisconsin, Forente stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, Forente stater, 53406
        • Aurora Cancer Care-Racine
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Saint Vincent Hospital Cancer Center at Sheboygan
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Sheboygan Physicians Group
      • Stevens Point, Wisconsin, Forente stater, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Sturgeon Bay, Wisconsin, Forente stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, Forente stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forente stater, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, Forente stater, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Forente stater, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wauwatosa, Wisconsin, Forente stater, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Forente stater, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, Forente stater, 54476
        • Marshfield Medical Center - Weston

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically-proven glioblastoma (World Health Organization [WHO] 2021 criteria)

  • Progressive or recurrent disease per Response Assessment in Neuro-Oncology (RANO) criteria

  • No IDH mutation (IDH1 R132H negative by immunohistochemistry [IHC] or sequencing)

  • Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide

  • No prior therapies except radiation, surgery, temozolomide, Tumor Treating Fields (TTFields), and/or Gliadel wafers (placed during the first surgery at diagnosis of glioblastoma multiforme [GBM]). Prior radiation therapy, TTFields, or placement of Gliadel wafers must be completed at least 2 weeks prior to registration. Prior temozolomide must be completed at least 3 weeks prior to registration

  • No prior use of nivolumab or other anti-PD1 agents

  • Patients must be neurologically stable off corticosteroids for at least 5 days prior to registration

  • Age: ≥ 18 years

  • Karnofsky Performance Status: ≥ 60% (i.e. patient must be able to care for themselves with occasional help from others)

  • Absolute lymphocyte count (ALC): ≥ 1000/mm^3

  • Absolute neutrophil count (ANC): ≥ 1500/mm^3

  • Platelet count: ≥ 100,000/mm^3

  • Hemoglobin: ≥ 9.0 g/dL

  • Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT): ≤ 1.5 x upper limit of normal (ULN)

  • Total bilirubin: < 2.0 x ULN (Except for patients with Gilbert's syndrome, who must have direct bilirubin < 2.0 x ULN)

  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT): < 3.0 x ULN

  • Calculated (calc.) creatinine clearance (CrCl): ≥ 50 mL/min

    • Calculated by Cockcroft-Gault equation

  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done within 14 days prior to registration is required

  • 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

  • No active brain metastases or leptomeningeal disease

  • HIV: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial

  • Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • Hepatitis C: 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

  • No known medical condition causing an inability to swallow oral formulations of agents

  • No current symptomatic pulmonary disease

  • No autoimmune disorders that require systemic treatment (except hyperthyroidism or diabetes mellitus)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I (nivolumab, relatlimab)

Patients receive nivolumab IV over 30 minutes followed by relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Biopsy Procedure

Undergo biopsy

Andre navn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Biologisk: Nivolumab

Given IV

Andre navn:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Biologisk: Relatlimab

Given IV

Andre navn:
  • BMS-986016
  • BMS986016
  • Immunoglobulin G4, Anti-(humant lymfocyttaktiveringsgen-3-protein) (Human Heavy Chain), Disulfid med Human Light Chain, Dimer
  • BMS 986016
Fremgangsmåte: Surgical Procedure

Undergo surgery

Andre navn:
  • Operasjon
  • Kirurgi
  • Kirurgi type
  • Kirurgisk
  • Kirurgisk inngrep
  • Kirurgiske inngrep
  • Kirurgiske prosedyrer
  • Type kirurgi
  • Kirurgi, NOS
Aktiv komparator: Arm II (lomustine)

Patients receive lomustine PO on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Biopsy Procedure

Undergo biopsy

Andre navn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Fremgangsmåte: Surgical Procedure

Undergo surgery

Andre navn:
  • Operasjon
  • Kirurgi
  • Kirurgi type
  • Kirurgisk
  • Kirurgisk inngrep
  • Kirurgiske inngrep
  • Kirurgiske prosedyrer
  • Type kirurgi
  • Kirurgi, NOS
Legemiddel: Lomustine

Given PO

Andre navn:
  • CCNU
  • CeeNU
  • Gleostine
  • 1-(2-kloretyl)-3-cykloheksyl-1-nitrosourea
  • 1-Nitrosourea, 1-(2-kloretyl)-3-cykloheksyl-
  • Belustin
  • Belustine
  • Cecenu
  • Kloretylcykloheksylnitrosourea
  • Citostal
  • Lomeblastin
  • Lomustinum
  • Lucostin
  • Lucostine
  • N-(2-kloretyl)-N'-cykloheksyl-N-nitrosourea
  • Prava
  • RB-1509
  • WR-139017

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: From randomization until death due to any cause, assessed at 30 months

The comparison of OS between the arms will be made with respect to restricted mean survival time (RMST) at 30 months. The RMST difference between arms will be determined as a point estimate with a corresponding 90% confidence interval (CI).
From randomization until death due to any cause, assessed at 30 months
OS rate
Tidsramme: From randomization until death due to any cause, assessed at 12 months

The OS rate between the 2 arms will be compared using a chi-square test. The point estimate and corresponding 90% CI will be generated for the difference in proportion.
From randomization until death due to any cause, assessed at 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progresjonsfri overlevelse
Tidsramme: Fra randomisering inntil bekreftet sykdomsprogresjon som vurdert av den behandlende legen eller døden på grunn av enhver årsak, avhengig av hva som skjer først, vurderte opptil 5 år
Fra randomisering inntil bekreftet sykdomsprogresjon som vurdert av den behandlende legen eller døden på grunn av enhver årsak, avhengig av hva som skjer først, vurderte opptil 5 år
Radiographic response
Tidsramme: Up to 5 years

Radiographic response will be assessed using Immunotherapy Response Assessment in Neuro-Oncology criteria. Patients with a complete response or partial response will be deemed a radiographic response. Patients with no follow-up imaging assessment will be deemed as a non-response. The proportion of patients with a radiographic response will be compared between the treatment arms with a Fisher's exact test.
Up to 5 years
Incidence of adverse events (AEs)
Tidsramme: Up to 5 years

AEs will be assessed using Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient. The number (percent) of patients that experience each observed AE will be summarized by the treatment a patient received. The proportion of patients who experience a grade 3+, a grade 4+, and grade 5 AEs will be summarized by number and percent for each treatment arm. The primary summary will be for AEs regardless of attribution to treatment. An analogous summary will be performed for AEs deemed at least possibly related to treatment.
Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Michael Lim, Alliance for Clinical Trials in Oncology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. november 2024

Primær fullføring (Antatt)

15. juli 2029

Studiet fullført (Antatt)

15. juli 2029

Datoer for studieregistrering

Først innsendt

20. mars 2024

Først innsendt som oppfylte QC-kriteriene

20. mars 2024

Først lagt ut (Faktiske)

22. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2024-01995
  • U10CA180821 (U.S. NIH-stipend/kontrakt)
  • NCI-2024-01995 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • A072201 (Annen identifikator: CTEP)
  • A072201 (Annen identifikator: Alliance for Clinical Trials in Oncology)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere