Anti-Lag-3 (Relatlinib) og Anti-PD-1 blokade (Nivolumab) versus standardbehandling (Lomustine) til behandling af patienter med tilbagevendende glioblastom
31. oktober 2026 opdateret af: National Cancer Institute (NCI)
Randomiseret fase II-forsøg med Anti-Lag-3 og Anti-PD-1 blokade vs. SOC hos patienter med recidiverende 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.
Studieoversigt
Status
Status
Suspenderet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
184
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Jonesboro, Arkansas, Forenede Stater, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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California
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Auburn, California, Forenede Stater, 95602
- Sutter Auburn Faith Hospital
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Duarte, California, Forenede Stater, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Forenede Stater, 94568
- Kaiser Permanente Dublin
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Fremont, California, Forenede Stater, 94538
- Kaiser Permanente-Fremont
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Fresno, California, Forenede Stater, 93720
- Kaiser Permanente Fresno Orchard Plaza
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Irvine, California, Forenede Stater, 92612
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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La Jolla, California, Forenede Stater, 92093
- UC San Diego Moores Cancer Center
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Lancaster, California, Forenede Stater, 93534
- City of Hope Antelope Valley
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Long Beach, California, Forenede Stater, 90813
- City of Hope at Long Beach Elm
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90027
- Kaiser Permanente Los Angeles Medical Center
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Modesto, California, Forenede Stater, 95356
- Kaiser Permanente-Modesto
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Modesto, California, Forenede Stater, 95356
- Kaiser Permanente- Modesto MOB II
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Oakland, California, Forenede Stater, 94611
- Kaiser Permanente-Oakland
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Orange, California, Forenede Stater, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Palo Alto, California, Forenede Stater, 94304
- Stanford Cancer Institute Palo Alto
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Palo Alto, California, Forenede Stater, 94301
- Palo Alto Medical Foundation Health Care
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Redwood City, California, Forenede Stater, 94063
- Kaiser Permanente- Marshall Medical Offices
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Roseville, California, Forenede Stater, 95661
- Kaiser Permanente-Roseville
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Roseville, California, Forenede Stater, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Forenede Stater, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Forenede Stater, 95814
- Kaiser Permanente Downtown Commons
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Sacramento, California, Forenede Stater, 95823
- Kaiser Permanente-South Sacramento
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San Diego, California, Forenede Stater, 92120
- Kaiser Permanente-San Diego Zion
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San Francisco, California, Forenede Stater, 94115
- Kaiser Permanente-San Francisco
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San Francisco, California, Forenede Stater, 94115
- California Pacific Medical Center-Pacific Campus
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San Jose, California, Forenede Stater, 95119
- Kaiser Permanente-Santa Teresa-San Jose
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San Leandro, California, Forenede Stater, 94577
- Kaiser Permanente San Leandro
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San Rafael, California, Forenede Stater, 94903
- Kaiser San Rafael-Gallinas
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Santa Clara, California, Forenede Stater, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Rosa, California, Forenede Stater, 95403
- Kaiser Permanente-Santa Rosa
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South San Francisco, California, Forenede Stater, 94080
- Kaiser Permanente-South San Francisco
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Upland, California, Forenede Stater, 91786
- City of Hope Upland
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Vallejo, California, Forenede Stater, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, Forenede Stater, 94596
- Kaiser Permanente-Walnut Creek
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Walnut Creek, California, Forenede Stater, 94598
- John Muir Medical Center-Walnut Creek
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- UCHealth Memorial Hospital Central
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Colorado Springs, Colorado, Forenede Stater, 80920
- Memorial Hospital North
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Denver, Colorado, Forenede Stater, 80205
- Kaiser Permanente-Franklin
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Fort Collins, Colorado, Forenede Stater, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, Forenede Stater, 80528
- Cancer Care and Hematology-Fort Collins
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Greeley, Colorado, Forenede Stater, 80631
- UCHealth Greeley Hospital
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Lafayette, Colorado, Forenede Stater, 80026
- Kaiser Permanente-Rock Creek
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Loveland, Colorado, Forenede Stater, 80538
- Medical Center of the Rockies
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06606
- Hartford HealthCare - Saint Vincent's Medical Center
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Trumbull, Connecticut, Forenede Stater, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Delaware
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Millville, Delaware, Forenede Stater, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Forenede Stater, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Forenede Stater, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Forenede Stater, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Sibley Memorial Hospital
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Florida
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Aventura, Florida, Forenede Stater, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables, Florida, Forenede Stater, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Coral Springs, Florida, Forenede Stater, 33065
- UM Sylvester Comprehensive Cancer Center at Coral Springs
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Deerfield Beach, Florida, Forenede Stater, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Doral, Florida, Forenede Stater, 33166
- UM Sylvester Comprehensive Cancer Center at Doral
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Gainesville, Florida, Forenede Stater, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Hollywood, Florida, Forenede Stater, 33021
- UM Sylvester Comprehensive Cancer Center at Hollywood
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist MD Anderson Cancer Center
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Jacksonville, Florida, Forenede Stater, 32224-9980
- Mayo Clinic in Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Forenede Stater, 33176
- Miami Cancer Institute
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Miami, Florida, Forenede Stater, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Orlando, Florida, Forenede Stater, 32806
- Orlando Health Cancer Institute
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Plantation, Florida, Forenede Stater, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Georgia
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Augusta, Georgia, Forenede Stater, 30912
- Augusta University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96819
- Kaiser Permanente Moanalua Medical Center
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Forenede Stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Forenede Stater, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Forenede Stater, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Forenede Stater, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Forenede Stater, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Illinois
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Aurora, Illinois, Forenede Stater, 60506
- Advocate Outpatient Center - Aurora
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Barrington, Illinois, Forenede Stater, 60010
- Advocate Good Shepherd Hospital
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Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
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Chicago, Illinois, Forenede Stater, 60657
- Advocate Illinois Masonic Medical Center
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Chicago, Illinois, Forenede Stater, 60612
- Rush MD Anderson Cancer Center
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Crystal Lake, Illinois, Forenede Stater, 60014
- AMG Crystal Lake - Oncology
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Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Forenede Stater, 61021
- Illinois CancerCare-Dixon
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Downers Grove, Illinois, Forenede Stater, 60515
- Advocate Good Samaritan Hospital
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Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
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Elgin, Illinois, Forenede Stater, 60123
- Advocate Sherman Hospital
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Forenede Stater, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
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Glenview, Illinois, Forenede Stater, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Hazel Crest, Illinois, Forenede Stater, 60429
- Advocate South Suburban Hospital
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
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Libertyville, Illinois, Forenede Stater, 60048
- Condell Memorial Hospital
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Libertyville, Illinois, Forenede Stater, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
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O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Forenede Stater, 62269
- HSHS Saint Elizabeth's Hospital
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Oak Lawn, Illinois, Forenede Stater, 60453-2699
- Advocate Christ Medical Center
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Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Outpatient Center - Oak Lawn
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Palos Heights, Illinois, Forenede Stater, 60463
- Advocate High Tech Medical Park
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Park Ridge, Illinois, Forenede Stater, 60068
- Advocate Lutheran General Hospital
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Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
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Shiloh, Illinois, Forenede Stater, 62269
- Memorial Hospital East
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Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Washington, Illinois, Forenede Stater, 61571
- Illinois CancerCare - Washington
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46237
- Franciscan Health Indianapolis
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Forenede Stater, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Bettendorf, Iowa, Forenede Stater, 52722
- University of Iowa Healthcare Cancer Services Quad Cities
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Boone, Iowa, Forenede Stater, 50036
- McFarland Clinic - Boone
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Carroll, Iowa, Forenede Stater, 51401
- Saint Anthony Regional Hospital
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Forenede Stater, 50501
- McFarland Clinic - Trinity Cancer Center
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Fort Dodge, Iowa, Forenede Stater, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Jefferson, Iowa, Forenede Stater, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Forenede Stater, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Forenede Stater, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, Forenede Stater, 66210
- University of Kansas Cancer Center-Overland Park
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Overland Park, Kansas, Forenede Stater, 66211
- University of Kansas Hospital-Indian Creek Campus
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Westwood, Kansas, Forenede Stater, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, Forenede Stater, 40202
- The James Graham Brown Cancer Center at University of Louisville
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Maine
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Brewer, Maine, Forenede Stater, 04412
- Lafayette Family Cancer Center-EMMC
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Scarborough, Maine, Forenede Stater, 04074
- MaineHealth Maine Medical Center- Scarborough
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South Portland, Maine, Forenede Stater, 04106
- MaineHealth Cancer Care and IV Therapy - South Portland
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Rogel Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brighton, Michigan, Forenede Stater, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Forenede Stater, 48116
- University of Michigan - Brighton Center for Specialty Care
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Canton, Michigan, Forenede Stater, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Chelsea, Michigan, Forenede Stater, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Escanaba, Michigan, Forenede Stater, 49829
- OSF Saint Francis Hospital and Medical Group
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Cancer Hematology Centers - Flint
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Lansing, Michigan, Forenede Stater, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Forenede Stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Ypsilanti, Michigan, Forenede Stater, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- Sanford Joe Lueken Cancer Center
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Brainerd, Minnesota, Forenede Stater, 56401
- Essentia Health Saint Joseph's Medical Center
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Deer River, Minnesota, Forenede Stater, 56636
- Essentia Health - Deer River Clinic
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Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Cancer Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Hibbing, Minnesota, Forenede Stater, 55746
- Essentia Health Hibbing Clinic
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Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Sandstone, Minnesota, Forenede Stater, 55072
- Essentia Health Sandstone
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Virginia, Minnesota, Forenede Stater, 55792
- Essentia Health Virginia Clinic
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Mississippi
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Columbus, Mississippi, Forenede Stater, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
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Grenada, Mississippi, Forenede Stater, 38901
- Baptist Cancer Center-Grenada
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New Albany, Mississippi, Forenede Stater, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
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Oxford, Mississippi, Forenede Stater, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Southhaven, Mississippi, Forenede Stater, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Forenede Stater, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Forenede Stater, 63141
- Siteman Cancer Center at West County Hospital
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Forenede Stater, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Forenede Stater, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
-
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Montana
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Anaconda, Montana, Forenede Stater, 59711
- Community Hospital of Anaconda
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Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Forenede Stater, 59901
- Logan Health Medical Center
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Missoula, Montana, Forenede Stater, 59804
- Community Medical Center
-
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68123
- Nebraska Medicine-Bellevue
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Omaha, Nebraska, Forenede Stater, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Forenede Stater, 68118
- Nebraska Medicine-Village Pointe
-
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
-
-
New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper Hospital University Medical Center
-
Edison, New Jersey, Forenede Stater, 08818
- John F Kennedy Medical Center
-
Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
-
Jersey City, New Jersey, Forenede Stater, 07302
- Jersey City Medical Center
-
Livingston, New Jersey, Forenede Stater, 07039
- Cooperman Barnabas Medical Center
-
Long Branch, New Jersey, Forenede Stater, 07740
- Monmouth Medical Center
-
Morristown, New Jersey, Forenede Stater, 07960
- Morristown Medical Center
-
Neptune City, New Jersey, Forenede Stater, 07753
- Jersey Shore Medical Center
-
New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
-
Sewell, New Jersey, Forenede Stater, 08080
- Sidney Kimmel Cancer Center Washington Township
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Summit, New Jersey, Forenede Stater, 07902
- Overlook Hospital
-
Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
-
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Forenede Stater, 87110
- Presbyterian Kaseman Hospital
-
Rio Rancho, New Mexico, Forenede Stater, 87124
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
-
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New York
-
Bay Shore, New York, Forenede Stater, 11706
- Northwell Health Imbert Cancer Center
-
Brooklyn, New York, Forenede Stater, 11220
- NYU Langone Hospital - Brooklyn
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
Glens Falls, New York, Forenede Stater, 12801
- Glens Falls Hospital
-
Lake Success, New York, Forenede Stater, 11042
- Northwell Health/Center for Advanced Medicine
-
Mineola, New York, Forenede Stater, 11501
- NYU Langone Hospital - Long Island
-
New York, New York, Forenede Stater, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Forenede Stater, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Oswego, New York, Forenede Stater, 13126
- Upstate Cancer Center at Oswego
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Einstein Campus
-
-
North Carolina
-
Pinehurst, North Carolina, Forenede Stater, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Sanford Bismarck Medical Center
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Fargo, North Dakota, Forenede Stater, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Forenede Stater, 58103
- Essentia Health Cancer Center-South University Clinic
-
Fargo, North Dakota, Forenede Stater, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Centerville, Ohio, Forenede Stater, 45459
- Miami Valley Hospital South
-
Cincinnati, Ohio, Forenede Stater, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45220
- Good Samaritan Hospital - Cincinnati
-
Columbus, Ohio, Forenede Stater, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Forenede Stater, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Forenede Stater, 45409
- Premier Blood and Cancer Center
-
Franklin, Ohio, Forenede Stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, Forenede Stater, 45331
- Miami Valley Cancer Care and Infusion
-
Troy, Ohio, Forenede Stater, 45373
- Upper Valley Medical Center
-
West Chester, Ohio, Forenede Stater, 45069
- University of Cincinnati Cancer Center-West Chester
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Gresham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
-
Ontario, Oregon, Forenede Stater, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
-
Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Forenede Stater, 97225
- Providence Saint Vincent Medical Center
-
Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
-
East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Medical Center
-
Erie, Pennsylvania, Forenede Stater, 16505
- UPMC Hillman Cancer Center Erie
-
Erie, Pennsylvania, Forenede Stater, 16544
- Saint Vincent Hospital
-
Jefferson Hills, Pennsylvania, Forenede Stater, 15025
- Jefferson Hospital
-
Monroeville, Pennsylvania, Forenede Stater, 15146
- Forbes Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Hillman Cancer Center
-
Wexford, Pennsylvania, Forenede Stater, 15090
- Wexford Health and Wellness Pavilion
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Forenede Stater, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Collierville, Tennessee, Forenede Stater, 38017
- Baptist Memorial Hospital and Cancer Center-Collierville
-
Memphis, Tennessee, Forenede Stater, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute/University of Utah
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Forenede Stater, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Inova Schar Cancer Institute
-
Mechanicsville, Virginia, Forenede Stater, 23116
- Bon Secours Memorial Regional Medical Center
-
Midlothian, Virginia, Forenede Stater, 23114
- Bon Secours Saint Francis Medical Center
-
Richmond, Virginia, Forenede Stater, 23226
- Bon Secours Saint Mary's Hospital
-
Richmond, Virginia, Forenede Stater, 23223
- Bon Secours Richmond Community Hospital
-
Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Vancouver, Washington, Forenede Stater, 98686
- Legacy Salmon Creek Hospital
-
Vancouver, Washington, Forenede Stater, 98684
- Legacy Cancer Institute Medical Oncology and Day Treatment
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Forenede Stater, 26101
- Camden Clark Medical Center
-
Wheeling, West Virginia, Forenede Stater, 26003
- Wheeling Hospital/Schiffler Cancer Center
-
-
Wisconsin
-
Ashland, Wisconsin, Forenede Stater, 54806
- Duluth Clinic Ashland
-
Burlington, Wisconsin, Forenede Stater, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Cudahy, Wisconsin, Forenede Stater, 53110
- Aurora Saint Luke's South Shore
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Medical Center-EC Cancer Center
-
Germantown, Wisconsin, Forenede Stater, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Forenede Stater, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Forenede Stater, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, Forenede Stater, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Janesville, Wisconsin, Forenede Stater, 53548
- Mercyhealth Hospital and Cancer Center - Janesville
-
Kenosha, Wisconsin, Forenede Stater, 53142
- Aurora Cancer Care-Kenosha South
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Madison, Wisconsin, Forenede Stater, 53718
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
-
Marinette, Wisconsin, Forenede Stater, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Forenede Stater, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53233
- Aurora Sinai Medical Center
-
Mukwonago, Wisconsin, Forenede Stater, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, Forenede Stater, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, Forenede Stater, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, Forenede Stater, 53406
- Aurora Cancer Care-Racine
-
Sheboygan, Wisconsin, Forenede Stater, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sheboygan, Wisconsin, Forenede Stater, 53081
- Saint Vincent Hospital Cancer Center at Sheboygan
-
Sheboygan, Wisconsin, Forenede Stater, 53081
- Sheboygan Physicians Group
-
Stevens Point, Wisconsin, Forenede Stater, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, Forenede Stater, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Forenede Stater, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, Forenede Stater, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Forenede Stater, 53188
- ProHealth Waukesha Memorial Hospital
-
Wauwatosa, Wisconsin, Forenede Stater, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Forenede Stater, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Medical Center - Weston
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Undergo blood sample collection
Andre navne:
Undergo MRI
Andre navne:
Undergo biopsy
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
Undergo surgery
Andre navne:
|
|
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. |
Undergo blood sample collection
Andre navne:
Undergo MRI
Andre navne:
Undergo biopsy
Andre navne:
Undergo surgery
Andre navne:
Given PO
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-fri overlevelse
Tidsramme: Fra randomisering til bekræftet sygdomsprogression som vurderet af den behandlende læge eller død på grund af enhver årsag, alt efter hvad der først sker, vurderet op til 5 år
|
Fra randomisering til bekræftet sygdomsprogression som vurderet af den behandlende læge eller død på grund af enhver årsag, alt efter hvad der først sker, vurderet op til 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Michael Lim, Alliance for Clinical Trials in Oncology
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
8. november 2024
Primær færdiggørelse (Anslået)
Primær færdiggørelse
15. juli 2029
Studieafslutning (Anslået)
Studieafslutning
15. juli 2029
Datoer for studieregistrering
Først indsendt
Først indsendt
20. marts 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
20. marts 2024
Først opslået (Faktiske)
Først opslået
22. marts 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Aminosyrer, peptider og proteiner
- Proteiner
- Svovlforbindelser
- Organiske kemikalier
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Cytologiske teknikker
- Cytodiagnose
- Amider
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Uorganiske kemikalier
- Diagnostiske teknikker, kirurgisk
- Kemiteknikker, analytisk
- Spektrumanalyse
- Immunoglobulin -isotyper
- Sulfider
- Anioner
- Ioner
- Elektrolytter
- Hydrogensulfid
- Nitrosourea -forbindelser
- Urea
- Nitroso -forbindelser
- Nivolumab
- Immunoglobulin G
- Lomustine
- Biopsi
- Håndtering af eksemplar
- Magnetisk resonansspektroskopi
- Disulfider
- Kirurgiske procedurer, operative
- Relatlimab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- NCI-2024-01995
- U10CA180821 (U.S. NIH-bevilling/kontrakt)
- NCI-2024-01995 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- A072201 (Anden identifikator: CTEP)
- A072201 (Anden identifikator: Alliance for Clinical Trials in Oncology)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .