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재발성 교모세포종 환자 치료를 위한 항Lag-3(Relatlinib) 및 항PD-1 차단(Nivolumab)과 표준 치료(Lomustine) 비교

2026년 10월 31일 업데이트: National Cancer Institute (NCI)

재발성 교모세포종 환자를 대상으로 항Lag-3 및 항PD-1 차단과 SOC의 무작위 제2상 시험

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.

연구 개요

상태

정지된

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

184

단계

2 단계

연락처 및 위치

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연구 장소

미국
- Arkansas
  - Jonesboro, Arkansas, 미국, 72401
    - NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- California
  - Auburn, California, 미국, 95602
    - Sutter Auburn Faith Hospital
  - Duarte, California, 미국, 91010
    - City of Hope Comprehensive Cancer Center
  - Dublin, California, 미국, 94568
    - Kaiser Permanente Dublin
  - Fremont, California, 미국, 94538
    - Kaiser Permanente-Fremont
  - Fresno, California, 미국, 93720
    - Kaiser Permanente Fresno Orchard Plaza
  - Irvine, California, 미국, 92612
    - UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
  - La Jolla, California, 미국, 92093
    - UC San Diego Moores Cancer Center
  - Lancaster, California, 미국, 93534
    - City of Hope Antelope Valley
  - Long Beach, California, 미국, 90813
    - City of Hope at Long Beach Elm
  - Los Angeles, California, 미국, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, 미국, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Modesto, California, 미국, 95356
    - Kaiser Permanente-Modesto
  - Modesto, California, 미국, 95356
    - Kaiser Permanente- Modesto MOB II
  - Oakland, California, 미국, 94611
    - Kaiser Permanente-Oakland
  - Orange, California, 미국, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Palo Alto, California, 미국, 94304
    - Stanford Cancer Institute Palo Alto
  - Palo Alto, California, 미국, 94301
    - Palo Alto Medical Foundation Health Care
  - Redwood City, California, 미국, 94063
    - Kaiser Permanente- Marshall Medical Offices
  - Roseville, California, 미국, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, 미국, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, 미국, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, 미국, 95814
    - Kaiser Permanente Downtown Commons
  - Sacramento, California, 미국, 95823
    - Kaiser Permanente-South Sacramento
  - San Diego, California, 미국, 92120
    - Kaiser Permanente-San Diego Zion
  - San Francisco, California, 미국, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, 미국, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, 미국, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, 미국, 94577
    - Kaiser Permanente San Leandro
  - San Rafael, California, 미국, 94903
    - Kaiser San Rafael-Gallinas
  - Santa Clara, California, 미국, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, 미국, 95403
    - Kaiser Permanente-Santa Rosa
  - South San Francisco, California, 미국, 94080
    - Kaiser Permanente-South San Francisco
  - Upland, California, 미국, 91786
    - City of Hope Upland
  - Vallejo, California, 미국, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, 미국, 94596
    - Kaiser Permanente-Walnut Creek
  - Walnut Creek, California, 미국, 94598
    - John Muir Medical Center-Walnut Creek
- Colorado
  - Colorado Springs, Colorado, 미국, 80909
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, 미국, 80920
    - Memorial Hospital North
  - Denver, Colorado, 미국, 80205
    - Kaiser Permanente-Franklin
  - Fort Collins, Colorado, 미국, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, 미국, 80528
    - Cancer Care and Hematology-Fort Collins
  - Greeley, Colorado, 미국, 80631
    - UCHealth Greeley Hospital
  - Lafayette, Colorado, 미국, 80026
    - Kaiser Permanente-Rock Creek
  - Loveland, Colorado, 미국, 80538
    - Medical Center of the Rockies
- Connecticut
  - Bridgeport, Connecticut, 미국, 06606
    - Hartford HealthCare - Saint Vincent's Medical Center
  - Hartford, Connecticut, 미국, 06102
    - Hartford Hospital
  - New Haven, Connecticut, 미국, 06520
    - Yale University
  - Trumbull, Connecticut, 미국, 06611
    - Smilow Cancer Hospital Care Center-Trumbull
- Delaware
  - Millville, Delaware, 미국, 19967
    - Beebe South Coastal Health Campus
  - Newark, Delaware, 미국, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, 미국, 19713
    - Medical Oncology Hematology Consultants PA
  - Rehoboth Beach, Delaware, 미국, 19971
    - Beebe Health Campus
- District of Columbia
  - Washington D.C., District of Columbia, 미국, 20016
    - Sibley Memorial Hospital
- Florida
  - Aventura, Florida, 미국, 33180
    - UM Sylvester Comprehensive Cancer Center at Aventura
  - Coral Gables, Florida, 미국, 33146
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Coral Springs, Florida, 미국, 33065
    - UM Sylvester Comprehensive Cancer Center at Coral Springs
  - Deerfield Beach, Florida, 미국, 33442
    - UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  - Doral, Florida, 미국, 33166
    - UM Sylvester Comprehensive Cancer Center at Doral
  - Gainesville, Florida, 미국, 32610
    - UF Health Cancer Institute - Gainesville
  - Hollywood, Florida, 미국, 33021
    - Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  - Hollywood, Florida, 미국, 33021
    - UM Sylvester Comprehensive Cancer Center at Hollywood
  - Jacksonville, Florida, 미국, 32207
    - Baptist MD Anderson Cancer Center
  - Jacksonville, Florida, 미국, 32224-9980
    - Mayo Clinic in Florida
  - Miami, Florida, 미국, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, 미국, 33176
    - Miami Cancer Institute
  - Miami, Florida, 미국, 33176
    - UM Sylvester Comprehensive Cancer Center at Kendall
  - Orlando, Florida, 미국, 32806
    - Orlando Health Cancer Institute
  - Plantation, Florida, 미국, 33324
    - UM Sylvester Comprehensive Cancer Center at Plantation
- Georgia
  - Augusta, Georgia, 미국, 30912
    - Augusta University Medical Center
- Hawaii
  - Honolulu, Hawaii, 미국, 96819
    - Kaiser Permanente Moanalua Medical Center
- Idaho
  - Boise, Idaho, 미국, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, 미국, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, 미국, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, 미국, 83814
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, 미국, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, 미국, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, 미국, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, 미국, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, 미국, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, 미국, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
- Illinois
  - Aurora, Illinois, 미국, 60506
    - Advocate Outpatient Center - Aurora
  - Barrington, Illinois, 미국, 60010
    - Advocate Good Shepherd Hospital
  - Bloomington, Illinois, 미국, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, 미국, 61520
    - Illinois CancerCare-Canton
  - Carthage, Illinois, 미국, 62321
    - Illinois CancerCare-Carthage
  - Chicago, Illinois, 미국, 60612
    - University of Illinois
  - Chicago, Illinois, 미국, 60657
    - Advocate Illinois Masonic Medical Center
  - Chicago, Illinois, 미국, 60612
    - Rush MD Anderson Cancer Center
  - Crystal Lake, Illinois, 미국, 60014
    - AMG Crystal Lake - Oncology
  - Decatur, Illinois, 미국, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, 미국, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, 미국, 61021
    - Illinois CancerCare-Dixon
  - Downers Grove, Illinois, 미국, 60515
    - Advocate Good Samaritan Hospital
  - Effingham, Illinois, 미국, 62401
    - Crossroads Cancer Center
  - Elgin, Illinois, 미국, 60123
    - Advocate Sherman Hospital
  - Eureka, Illinois, 미국, 61530
    - Illinois CancerCare-Eureka
  - Evanston, Illinois, 미국, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Galesburg, Illinois, 미국, 61401
    - Illinois CancerCare-Galesburg
  - Glenview, Illinois, 미국, 60026
    - NorthShore University HealthSystem-Glenbrook Hospital
  - Hazel Crest, Illinois, 미국, 60429
    - Advocate South Suburban Hospital
  - Kewanee, Illinois, 미국, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Libertyville, Illinois, 미국, 60048
    - Condell Memorial Hospital
  - Libertyville, Illinois, 미국, 60048
    - AMG Libertyville - Oncology
  - Macomb, Illinois, 미국, 61455
    - Illinois CancerCare-Macomb
  - O'Fallon, Illinois, 미국, 62269
    - Cancer Care Center of O'Fallon
  - O'Fallon, Illinois, 미국, 62269
    - HSHS Saint Elizabeth's Hospital
  - Oak Lawn, Illinois, 미국, 60453-2699
    - Advocate Christ Medical Center
  - Oak Lawn, Illinois, 미국, 60453
    - Advocate Outpatient Center - Oak Lawn
  - Ottawa, Illinois, 미국, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Palos Heights, Illinois, 미국, 60463
    - Advocate High Tech Medical Park
  - Park Ridge, Illinois, 미국, 60068
    - Advocate Lutheran General Hospital
  - Pekin, Illinois, 미국, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, 미국, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, 미국, 61354
    - Illinois CancerCare-Peru
  - Princeton, Illinois, 미국, 61356
    - Illinois CancerCare-Princeton
  - Shiloh, Illinois, 미국, 62269
    - Memorial Hospital East
  - Springfield, Illinois, 미국, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, 미국, 62702
    - Springfield Clinic
  - Springfield, Illinois, 미국, 62781
    - Springfield Memorial Hospital
  - Washington, Illinois, 미국, 61571
    - Illinois CancerCare - Washington
- Indiana
  - Indianapolis, Indiana, 미국, 46237
    - Franciscan Health Indianapolis
- Iowa
  - Ames, Iowa, 미국, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, 미국, 50010
    - McFarland Clinic - Ames
  - Ankeny, Iowa, 미국, 50023
    - UI Health Care Mission Cancer and Blood - Ankeny Clinic
  - Bettendorf, Iowa, 미국, 52722
    - University of Iowa Healthcare Cancer Services Quad Cities
  - Boone, Iowa, 미국, 50036
    - McFarland Clinic - Boone
  - Carroll, Iowa, 미국, 51401
    - Saint Anthony Regional Hospital
  - Cedar Rapids, Iowa, 미국, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, 미국, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, 미국, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Des Moines, Iowa, 미국, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, 미국, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, 미국, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, 미국, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Fort Dodge, Iowa, 미국, 50501
    - McFarland Clinic - Trinity Cancer Center
  - Fort Dodge, Iowa, 미국, 50501
    - UI Healthcare Mission Cancer and Blood - Fort Dodge
  - Iowa City, Iowa, 미국, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Jefferson, Iowa, 미국, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, 미국, 50158
    - McFarland Clinic - Marshalltown
  - Waukee, Iowa, 미국, 50263
    - UI Health Care Mission Cancer and Blood - Waukee Clinic
- Kansas
  - Kansas City, Kansas, 미국, 66160
    - University of Kansas Cancer Center
  - Overland Park, Kansas, 미국, 66210
    - University of Kansas Cancer Center-Overland Park
  - Overland Park, Kansas, 미국, 66211
    - University of Kansas Hospital-Indian Creek Campus
  - Westwood, Kansas, 미국, 66205
    - University of Kansas Hospital-Westwood Cancer Center
- Kentucky
  - Lexington, Kentucky, 미국, 40536
    - University of Kentucky/Markey Cancer Center
  - Louisville, Kentucky, 미국, 40202
    - The James Graham Brown Cancer Center at University of Louisville
- Maine
  - Brewer, Maine, 미국, 04412
    - Lafayette Family Cancer Center-EMMC
  - Scarborough, Maine, 미국, 04074
    - MaineHealth Maine Medical Center- Scarborough
  - South Portland, Maine, 미국, 04106
    - MaineHealth Cancer Care and IV Therapy - South Portland
- Maryland
  - Baltimore, Maryland, 미국, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
- Massachusetts
  - Boston, Massachusetts, 미국, 02111
    - Tufts Medical Center
- Michigan
  - Ann Arbor, Michigan, 미국, 48109
    - University of Michigan Rogel Cancer Center
  - Ann Arbor, Michigan, 미국, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Brighton, Michigan, 미국, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, 미국, 48116
    - University of Michigan - Brighton Center for Specialty Care
  - Canton, Michigan, 미국, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Chelsea, Michigan, 미국, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Detroit, Michigan, 미국, 48202
    - Henry Ford Hospital
  - Escanaba, Michigan, 미국, 49829
    - OSF Saint Francis Hospital and Medical Group
  - Flint, Michigan, 미국, 48503
    - Hurley Medical Center
  - Flint, Michigan, 미국, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, 미국, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, 미국, 48503
    - Cancer Hematology Centers - Flint
  - Lansing, Michigan, 미국, 48912
    - University of Michigan Health - Sparrow Lansing
  - Livonia, Michigan, 미국, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Ypsilanti, Michigan, 미국, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Bemidji, Minnesota, 미국, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, 미국, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Coon Rapids, Minnesota, 미국, 55433
    - Mercy Hospital
  - Deer River, Minnesota, 미국, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, 미국, 55805
    - Essentia Health Cancer Center
  - Edina, Minnesota, 미국, 55435
    - Fairview Southdale Hospital
  - Hibbing, Minnesota, 미국, 55746
    - Essentia Health Hibbing Clinic
  - Minneapolis, Minnesota, 미국, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, 미국, 55407
    - Abbott-Northwestern Hospital
  - Saint Louis Park, Minnesota, 미국, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, 미국, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, 미국, 55102
    - United Hospital
  - Sandstone, Minnesota, 미국, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, 미국, 55792
    - Essentia Health Virginia Clinic
- Mississippi
  - Columbus, Mississippi, 미국, 39705
    - Baptist Memorial Hospital and Cancer Center-Golden Triangle
  - Grenada, Mississippi, 미국, 38901
    - Baptist Cancer Center-Grenada
  - New Albany, Mississippi, 미국, 38652
    - Baptist Memorial Hospital and Cancer Center-Union County
  - Oxford, Mississippi, 미국, 38655
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southhaven, Mississippi, 미국, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Cape Girardeau, Missouri, 미국, 63703
    - Saint Francis Medical Center
  - City of Saint Peters, Missouri, 미국, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Creve Coeur, Missouri, 미국, 63141
    - Siteman Cancer Center at West County Hospital
  - St Louis, Missouri, 미국, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, 미국, 63129
    - Siteman Cancer Center-South County
  - St Louis, Missouri, 미국, 63136
    - Siteman Cancer Center at Christian Hospital
  - St Louis, Missouri, 미국, 63128
    - Mercy Hospital South
- Montana
  - Anaconda, Montana, 미국, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, 미국, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, 미국, 59715
    - Bozeman Health Deaconess Hospital
  - Great Falls, Montana, 미국, 59405
    - Benefis Sletten Cancer Institute
  - Kalispell, Montana, 미국, 59901
    - Logan Health Medical Center
  - Missoula, Montana, 미국, 59804
    - Community Medical Center
- Nebraska
  - Bellevue, Nebraska, 미국, 68123
    - Nebraska Medicine-Bellevue
  - Omaha, Nebraska, 미국, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, 미국, 68118
    - Nebraska Medicine-Village Pointe
- Nevada
  - Reno, Nevada, 미국, 89502
    - Renown Regional Medical Center
- New Hampshire
  - Lebanon, New Hampshire, 미국, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Jersey
  - Camden, New Jersey, 미국, 08103
    - Cooper Hospital University Medical Center
  - Edison, New Jersey, 미국, 08818
    - John F Kennedy Medical Center
  - Hackensack, New Jersey, 미국, 07601
    - Hackensack University Medical Center
  - Jersey City, New Jersey, 미국, 07302
    - Jersey City Medical Center
  - Livingston, New Jersey, 미국, 07039
    - Cooperman Barnabas Medical Center
  - Long Branch, New Jersey, 미국, 07740
    - Monmouth Medical Center
  - Morristown, New Jersey, 미국, 07960
    - Morristown Medical Center
  - Neptune City, New Jersey, 미국, 07753
    - Jersey Shore Medical Center
  - New Brunswick, New Jersey, 미국, 08903
    - Rutgers Cancer Institute of New Jersey
  - Newark, New Jersey, 미국, 07112
    - Newark Beth Israel Medical Center
  - Sewell, New Jersey, 미국, 08080
    - Sidney Kimmel Cancer Center Washington Township
  - Summit, New Jersey, 미국, 07902
    - Overlook Hospital
  - Toms River, New Jersey, 미국, 08755
    - Community Medical Center
- New Mexico
  - Albuquerque, New Mexico, 미국, 87106
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, 미국, 87110
    - Presbyterian Kaseman Hospital
  - Rio Rancho, New Mexico, 미국, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
- New York
  - Bay Shore, New York, 미국, 11706
    - Northwell Health Imbert Cancer Center
  - Brooklyn, New York, 미국, 11220
    - NYU Langone Hospital - Brooklyn
  - Buffalo, New York, 미국, 14263
    - Roswell Park Cancer Institute
  - Glens Falls, New York, 미국, 12801
    - Glens Falls Hospital
  - Lake Success, New York, 미국, 11042
    - Northwell Health/Center for Advanced Medicine
  - Mineola, New York, 미국, 11501
    - NYU Langone Hospital - Long Island
  - New York, New York, 미국, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, 미국, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Oswego, New York, 미국, 13126
    - Upstate Cancer Center at Oswego
  - Rochester, New York, 미국, 14642
    - University of Rochester
  - Syracuse, New York, 미국, 13210
    - State University of New York Upstate Medical University
  - The Bronx, New York, 미국, 10461
    - Montefiore Medical Center-Einstein Campus
- North Carolina
  - Pinehurst, North Carolina, 미국, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
- North Dakota
  - Bismarck, North Dakota, 미국, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, 미국, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, 미국, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, 미국, 58122
    - Sanford Broadway Medical Center
- Ohio
  - Centerville, Ohio, 미국, 45459
    - Miami Valley Hospital South
  - Cincinnati, Ohio, 미국, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cincinnati, Ohio, 미국, 45220
    - Good Samaritan Hospital - Cincinnati
  - Columbus, Ohio, 미국, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, 미국, 43210
    - Ohio State University Comprehensive Cancer Center
  - Dayton, Ohio, 미국, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, 미국, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, 미국, 45409
    - Premier Blood and Cancer Center
  - Franklin, Ohio, 미국, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, 미국, 45331
    - Miami Valley Cancer Care and Infusion
  - Troy, Ohio, 미국, 45373
    - Upper Valley Medical Center
  - West Chester, Ohio, 미국, 45069
    - University of Cincinnati Cancer Center-West Chester
- Oklahoma
  - Oklahoma City, Oklahoma, 미국, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Gresham, Oregon, 미국, 97030
    - Legacy Mount Hood Medical Center
  - Ontario, Oregon, 미국, 97914
    - Saint Alphonsus Cancer Care Center-Ontario
  - Portland, Oregon, 미국, 97239
    - Oregon Health and Science University
  - Portland, Oregon, 미국, 97210
    - Legacy Good Samaritan Hospital and Medical Center
  - Portland, Oregon, 미국, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, 미국, 97225
    - Providence Saint Vincent Medical Center
  - Tualatin, Oregon, 미국, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Allentown, Pennsylvania, 미국, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, 미국, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - East Stroudsburg, Pennsylvania, 미국, 18301
    - Pocono Medical Center
  - Erie, Pennsylvania, 미국, 16505
    - UPMC Hillman Cancer Center Erie
  - Erie, Pennsylvania, 미국, 16544
    - Saint Vincent Hospital
  - Jefferson Hills, Pennsylvania, 미국, 15025
    - Jefferson Hospital
  - Monroeville, Pennsylvania, 미국, 15146
    - Forbes Hospital
  - Philadelphia, Pennsylvania, 미국, 19107
    - Thomas Jefferson University Hospital
  - Pittsburgh, Pennsylvania, 미국, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, 미국, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, 미국, 15232
    - UPMC Hillman Cancer Center
  - Wexford, Pennsylvania, 미국, 15090
    - Wexford Health and Wellness Pavilion
- South Carolina
  - Charleston, South Carolina, 미국, 29425
    - Medical University of South Carolina
- South Dakota
  - Sioux Falls, South Dakota, 미국, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, 미국, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Collierville, Tennessee, 미국, 38017
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Memphis, Tennessee, 미국, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
  - Nashville, Tennessee, 미국, 37232
    - Vanderbilt University/Ingram Cancer Center
- Utah
  - Salt Lake City, Utah, 미국, 84112
    - Huntsman Cancer Institute/University of Utah
- Vermont
  - Burlington, Vermont, 미국, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, 미국, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Fairfax, Virginia, 미국, 22031
    - Inova Schar Cancer Institute
  - Mechanicsville, Virginia, 미국, 23116
    - Bon Secours Memorial Regional Medical Center
  - Midlothian, Virginia, 미국, 23114
    - Bon Secours Saint Francis Medical Center
  - Richmond, Virginia, 미국, 23226
    - Bon Secours Saint Mary's Hospital
  - Richmond, Virginia, 미국, 23223
    - Bon Secours Richmond Community Hospital
  - Richmond, Virginia, 미국, 23298
    - VCU Massey Comprehensive Cancer Center
- Washington
  - Seattle, Washington, 미국, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Vancouver, Washington, 미국, 98686
    - Legacy Salmon Creek Hospital
  - Vancouver, Washington, 미국, 98684
    - Legacy Cancer Institute Medical Oncology and Day Treatment
- West Virginia
  - Morgantown, West Virginia, 미국, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, 미국, 26101
    - Camden Clark Medical Center
  - Wheeling, West Virginia, 미국, 26003
    - Wheeling Hospital/Schiffler Cancer Center
- Wisconsin
  - Ashland, Wisconsin, 미국, 54806
    - Duluth Clinic Ashland
  - Burlington, Wisconsin, 미국, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Cudahy, Wisconsin, 미국, 53110
    - Aurora Saint Luke's South Shore
  - Eau Claire, Wisconsin, 미국, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Germantown, Wisconsin, 미국, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, 미국, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, 미국, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, 미국, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, 미국, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Janesville, Wisconsin, 미국, 53548
    - Mercyhealth Hospital and Cancer Center - Janesville
  - Kenosha, Wisconsin, 미국, 53142
    - Aurora Cancer Care-Kenosha South
  - Madison, Wisconsin, 미국, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Madison, Wisconsin, 미국, 53718
    - University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
  - Marinette, Wisconsin, 미국, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, 미국, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, 미국, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, 미국, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, 미국, 53233
    - Aurora Sinai Medical Center
  - Mukwonago, Wisconsin, 미국, 53149
    - ProHealth D N Greenwald Center
  - Oconomowoc, Wisconsin, 미국, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, 미국, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Oshkosh, Wisconsin, 미국, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, 미국, 53406
    - Aurora Cancer Care-Racine
  - Sheboygan, Wisconsin, 미국, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Sheboygan, Wisconsin, 미국, 53081
    - Saint Vincent Hospital Cancer Center at Sheboygan
  - Sheboygan, Wisconsin, 미국, 53081
    - Sheboygan Physicians Group
  - Stevens Point, Wisconsin, 미국, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Sturgeon Bay, Wisconsin, 미국, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, 미국, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, 미국, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, 미국, 53188
    - UW Cancer Center at ProHealth Care
  - Waukesha, Wisconsin, 미국, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wauwatosa, Wisconsin, 미국, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, 미국, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, 미국, 54476
    - Marshfield Medical Center - Weston

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: 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.	절차: Biospecimen Collection Undergo blood sample collection 다른 이름들: 생물학적 샘플 수집 생체 표본 수집 표본 수집 샘플 수집 절차: Magnetic Resonance Imaging Undergo MRI 다른 이름들: MRI 자기 공명 자기공명영상 스캔 의료영상, 자기공명 / 핵자기공명 씨 MR 이미징 MRI 검사 NMR 이미징 NMRI 핵자기공명영상 자기공명영상(MRI) SMRI 자기공명영상(시술) 구조적 MRI 절차: Biopsy Procedure Undergo biopsy 다른 이름들: 비엑스 생검_유형 생검 생물학적: Nivolumab Given IV 다른 이름들: BMS-936558 MDX-1106 니보 ONO-4538 옵디보 CMAB819 니볼루맙 바이오시밀러 CMAB819 MDX 1106 MDX1106 BMS 936558 ABP 206 니볼루맙 바이오시밀러 ABP 206 BCD-263 니볼루맙 바이오시밀러 BCD-263 BMS936558 오노 4538 ONO4538 생물학적: Relatlimab Given IV 다른 이름들: BMS-986016 BMS986016 Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer BMS 986016 절차: Surgical Procedure Undergo surgery 다른 이름들: 작업 수술 수술 종류 외과 외과 개입 수술 절차 수술의 종류 수술, NOS
활성 비교기: 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.	절차: Biospecimen Collection Undergo blood sample collection 다른 이름들: 생물학적 샘플 수집 생체 표본 수집 표본 수집 샘플 수집 절차: Magnetic Resonance Imaging Undergo MRI 다른 이름들: MRI 자기 공명 자기공명영상 스캔 의료영상, 자기공명 / 핵자기공명 씨 MR 이미징 MRI 검사 NMR 이미징 NMRI 핵자기공명영상 자기공명영상(MRI) SMRI 자기공명영상(시술) 구조적 MRI 절차: Biopsy Procedure Undergo biopsy 다른 이름들: 비엑스 생검_유형 생검 절차: Surgical Procedure Undergo surgery 다른 이름들: 작업 수술 수술 종류 외과 외과 개입 수술 절차 수술의 종류 수술, NOS 의약품: Lomustine Given PO 다른 이름들: CCNU 씨뉴 글레오스틴 1-(2-클로로에틸)-3-시클로헥실-1-니트로소우레아 1-니트로소우레아, 1-(2-클로로에틸)-3-시클로헥실- 벨루스틴 체세누 클로로에틸시클로헥실니트로소우레아 키토스탈 로메블라스틴 로무스티눔 루코스틴 N-(2-클로로에틸)-N'-시클로헥실-N-니트로소우레아 프라바 RB-1509 WR-139017

참가자 그룹 / 팔

개입 / 치료

실험적: 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.

절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:

생물학적 샘플 수집
생체 표본 수집
표본 수집
샘플 수집

절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:

MRI
자기 공명
자기공명영상 스캔
의료영상, 자기공명 / 핵자기공명
씨
MR 이미징
MRI 검사
NMR 이미징
NMRI
핵자기공명영상
자기공명영상(MRI)
SMRI
자기공명영상(시술)
구조적 MRI

절차: Biopsy Procedure

Undergo biopsy

다른 이름들:

비엑스
생검_유형
생검

생물학적: Nivolumab

Given IV

다른 이름들:

BMS-936558
MDX-1106
니보
ONO-4538
옵디보
CMAB819
니볼루맙 바이오시밀러 CMAB819
MDX 1106
MDX1106
BMS 936558
ABP 206
니볼루맙 바이오시밀러 ABP 206
BCD-263
니볼루맙 바이오시밀러 BCD-263
BMS936558
오노 4538
ONO4538

생물학적: Relatlimab

Given IV

다른 이름들:

BMS-986016
BMS986016
Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
BMS 986016

절차: Surgical Procedure

Undergo surgery

다른 이름들:

작업
수술
수술 종류
외과
외과 개입
수술 절차
수술의 종류
수술, NOS

활성 비교기: 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.

절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:

생물학적 샘플 수집
생체 표본 수집
표본 수집
샘플 수집

절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:

MRI
자기 공명
자기공명영상 스캔
의료영상, 자기공명 / 핵자기공명
씨
MR 이미징
MRI 검사
NMR 이미징
NMRI
핵자기공명영상
자기공명영상(MRI)
SMRI
자기공명영상(시술)
구조적 MRI

절차: Biopsy Procedure

Undergo biopsy

다른 이름들:

비엑스
생검_유형
생검

절차: Surgical Procedure

Undergo surgery

다른 이름들:

작업
수술
수술 종류
외과
외과 개입
수술 절차
수술의 종류
수술, NOS

의약품: Lomustine

Given PO

다른 이름들:

CCNU
씨뉴
글레오스틴
1-(2-클로로에틸)-3-시클로헥실-1-니트로소우레아
1-니트로소우레아, 1-(2-클로로에틸)-3-시클로헥실-
벨루스틴
체세누
클로로에틸시클로헥실니트로소우레아
키토스탈
로메블라스틴
로무스티눔
루코스틴
N-(2-클로로에틸)-N'-시클로헥실-N-니트로소우레아
프라바
RB-1509
WR-139017

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Overall survival (OS) 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
진행이없는 생존 기간: 무작위 배정에서 확인 된 질병 진행까지 치료 의사 또는 사망에 의해 평가 된 경우, 어떤 원인으로 인해, 어느 쪽이든 최대 5 년까지 평가 된 것		무작위 배정에서 확인 된 질병 진행까지 치료 의사 또는 사망에 의해 평가 된 경우, 어떤 원인으로 인해, 어느 쪽이든 최대 5 년까지 평가 된 것
Radiographic response 기간: 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) 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

수석 연구원: Michael Lim, Alliance for Clinical Trials in Oncology

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 11월 8일

기본 완료 (추정된)

2029년 7월 15일

연구 완료 (추정된)

2029년 7월 15일

연구 등록 날짜

최초 제출

2024년 3월 20일

QC 기준을 충족하는 최초 제출

2024년 3월 20일

처음 게시됨 (실제)

2024년 3월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 31일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

NCI-2024-01995
U10CA180821 (미국 NIH 보조금/계약)
NCI-2024-01995 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
A072201 (기타 식별자: CTEP)
A072201 (기타 식별자: Alliance for Clinical Trials in Oncology)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

재발성 교모세포종 환자 치료를 위한 항Lag-3(Relatlinib) 및 항PD-1 차단(Nivolumab)과 표준 치료(Lomustine) 비교

재발성 교모세포종 환자를 대상으로 항Lag-3 및 항PD-1 차단과 SOC의 무작위 제2상 시험

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

미국에서 제조되어 미국에서 수출되는 제품