Anti-Lag-3 (Relatlinib) en anti-PD-1-blokkade (Nivolumab) versus standaardzorg (Lomustine) voor de behandeling van patiënten met recidiverend glioblastoom
31 oktober 2026 bijgewerkt door: National Cancer Institute (NCI)
Gerandomiseerd fase II-onderzoek naar anti-Lag-3- en anti-PD-1-blokkade versus SOC bij patiënten met recidiverend glioblastoom
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.
Studie Overzicht
Toestand
Geschorst
Gedetailleerde beschrijving
PRIMARY OBJECTIVE:
I. To compare the restricted mean survival time (RMST) for overall survival (OS) between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care chloroethylcyclohexylnitrosourea (CCNU) (lomustine).
SECONDARY OBJECTIVES:
I. To compare the 12-month OS rates between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).
II. To compare the restricted mean survival times for progression-free survival (PFS) between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).
III. To compare the radiographic response rate between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).
IV. To compare the safety/adverse event rate between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes followed by relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, magnetic resonance imaging (MRI), and blood sample collection throughout study.
ARM II: Patients receive lomustine orally (PO) on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study.
After completion of study treatment, patients are followed up every 6 months for up to 5 years from time of randomization.
Studietype
Ingrijpend
Inschrijving (Geschat)
184
Fase
- Fase 2
Contacten en locaties
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Studie Locaties
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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California
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Auburn, California, Verenigde Staten, 95602
- Sutter Auburn Faith Hospital
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Duarte, California, Verenigde Staten, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Verenigde Staten, 94568
- Kaiser Permanente Dublin
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Fremont, California, Verenigde Staten, 94538
- Kaiser Permanente-Fremont
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Fresno, California, Verenigde Staten, 93720
- Kaiser Permanente Fresno Orchard Plaza
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Irvine, California, Verenigde Staten, 92612
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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La Jolla, California, Verenigde Staten, 92093
- UC San Diego Moores Cancer Center
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Lancaster, California, Verenigde Staten, 93534
- City of Hope Antelope Valley
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Long Beach, California, Verenigde Staten, 90813
- City of Hope at Long Beach Elm
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Los Angeles, California, Verenigde Staten, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Verenigde Staten, 90027
- Kaiser Permanente Los Angeles Medical Center
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Modesto, California, Verenigde Staten, 95356
- Kaiser Permanente-Modesto
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Modesto, California, Verenigde Staten, 95356
- Kaiser Permanente- Modesto MOB II
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Oakland, California, Verenigde Staten, 94611
- Kaiser Permanente-Oakland
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Orange, California, Verenigde Staten, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Palo Alto, California, Verenigde Staten, 94304
- Stanford Cancer Institute Palo Alto
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Palo Alto, California, Verenigde Staten, 94301
- Palo Alto Medical Foundation Health Care
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Redwood City, California, Verenigde Staten, 94063
- Kaiser Permanente- Marshall Medical Offices
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Roseville, California, Verenigde Staten, 95661
- Kaiser Permanente-Roseville
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Roseville, California, Verenigde Staten, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Verenigde Staten, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Verenigde Staten, 95814
- Kaiser Permanente Downtown Commons
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Sacramento, California, Verenigde Staten, 95823
- Kaiser Permanente-South Sacramento
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San Diego, California, Verenigde Staten, 92120
- Kaiser Permanente-San Diego Zion
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San Francisco, California, Verenigde Staten, 94115
- Kaiser Permanente-San Francisco
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San Francisco, California, Verenigde Staten, 94115
- California Pacific Medical Center-Pacific Campus
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San Jose, California, Verenigde Staten, 95119
- Kaiser Permanente-Santa Teresa-San Jose
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San Leandro, California, Verenigde Staten, 94577
- Kaiser Permanente San Leandro
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San Rafael, California, Verenigde Staten, 94903
- Kaiser San Rafael-Gallinas
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Santa Clara, California, Verenigde Staten, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Rosa, California, Verenigde Staten, 95403
- Kaiser Permanente-Santa Rosa
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South San Francisco, California, Verenigde Staten, 94080
- Kaiser Permanente-South San Francisco
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Upland, California, Verenigde Staten, 91786
- City of Hope Upland
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Vallejo, California, Verenigde Staten, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, Verenigde Staten, 94596
- Kaiser Permanente-Walnut Creek
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Walnut Creek, California, Verenigde Staten, 94598
- John Muir Medical Center-Walnut Creek
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80909
- UCHealth Memorial Hospital Central
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Colorado Springs, Colorado, Verenigde Staten, 80920
- Memorial Hospital North
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Denver, Colorado, Verenigde Staten, 80205
- Kaiser Permanente-Franklin
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Fort Collins, Colorado, Verenigde Staten, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, Verenigde Staten, 80528
- Cancer Care and Hematology-Fort Collins
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Greeley, Colorado, Verenigde Staten, 80631
- UCHealth Greeley Hospital
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Lafayette, Colorado, Verenigde Staten, 80026
- Kaiser Permanente-Rock Creek
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Loveland, Colorado, Verenigde Staten, 80538
- Medical Center of the Rockies
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Connecticut
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Bridgeport, Connecticut, Verenigde Staten, 06606
- Hartford HealthCare - Saint Vincent's Medical Center
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Hartford, Connecticut, Verenigde Staten, 06102
- Hartford Hospital
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New Haven, Connecticut, Verenigde Staten, 06520
- Yale University
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Trumbull, Connecticut, Verenigde Staten, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Delaware
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Millville, Delaware, Verenigde Staten, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Verenigde Staten, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Verenigde Staten, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Verenigde Staten, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20016
- Sibley Memorial Hospital
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Florida
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Aventura, Florida, Verenigde Staten, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables, Florida, Verenigde Staten, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Coral Springs, Florida, Verenigde Staten, 33065
- UM Sylvester Comprehensive Cancer Center at Coral Springs
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Deerfield Beach, Florida, Verenigde Staten, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Doral, Florida, Verenigde Staten, 33166
- UM Sylvester Comprehensive Cancer Center at Doral
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Gainesville, Florida, Verenigde Staten, 32610
- UF Health Cancer Institute - Gainesville
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Hollywood, Florida, Verenigde Staten, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Hollywood, Florida, Verenigde Staten, 33021
- UM Sylvester Comprehensive Cancer Center at Hollywood
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Jacksonville, Florida, Verenigde Staten, 32207
- Baptist MD Anderson Cancer Center
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Jacksonville, Florida, Verenigde Staten, 32224-9980
- Mayo Clinic in Florida
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Miami, Florida, Verenigde Staten, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Verenigde Staten, 33176
- Miami Cancer Institute
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Miami, Florida, Verenigde Staten, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Orlando, Florida, Verenigde Staten, 32806
- Orlando Health Cancer Institute
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Plantation, Florida, Verenigde Staten, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Georgia
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Augusta, Georgia, Verenigde Staten, 30912
- Augusta University Medical Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96819
- Kaiser Permanente Moanalua Medical Center
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Idaho
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Boise, Idaho, Verenigde Staten, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Verenigde Staten, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Verenigde Staten, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Verenigde Staten, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Verenigde Staten, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Verenigde Staten, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Verenigde Staten, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Verenigde Staten, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Illinois
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Aurora, Illinois, Verenigde Staten, 60506
- Advocate Outpatient Center - Aurora
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Barrington, Illinois, Verenigde Staten, 60010
- Advocate Good Shepherd Hospital
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Bloomington, Illinois, Verenigde Staten, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Verenigde Staten, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Verenigde Staten, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois
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Chicago, Illinois, Verenigde Staten, 60657
- Advocate Illinois Masonic Medical Center
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Chicago, Illinois, Verenigde Staten, 60612
- Rush MD Anderson Cancer Center
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Crystal Lake, Illinois, Verenigde Staten, 60014
- AMG Crystal Lake - Oncology
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Decatur, Illinois, Verenigde Staten, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Verenigde Staten, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Verenigde Staten, 61021
- Illinois CancerCare-Dixon
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Downers Grove, Illinois, Verenigde Staten, 60515
- Advocate Good Samaritan Hospital
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Effingham, Illinois, Verenigde Staten, 62401
- Crossroads Cancer Center
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Elgin, Illinois, Verenigde Staten, 60123
- Advocate Sherman Hospital
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Eureka, Illinois, Verenigde Staten, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Verenigde Staten, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Verenigde Staten, 61401
- Illinois CancerCare-Galesburg
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Glenview, Illinois, Verenigde Staten, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Hazel Crest, Illinois, Verenigde Staten, 60429
- Advocate South Suburban Hospital
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Kewanee, Illinois, Verenigde Staten, 61443
- Illinois CancerCare-Kewanee Clinic
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Libertyville, Illinois, Verenigde Staten, 60048
- Condell Memorial Hospital
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Libertyville, Illinois, Verenigde Staten, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Verenigde Staten, 61455
- Illinois CancerCare-Macomb
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O'Fallon, Illinois, Verenigde Staten, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Verenigde Staten, 62269
- HSHS Saint Elizabeth's Hospital
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Oak Lawn, Illinois, Verenigde Staten, 60453-2699
- Advocate Christ Medical Center
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Oak Lawn, Illinois, Verenigde Staten, 60453
- Advocate Outpatient Center - Oak Lawn
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Ottawa, Illinois, Verenigde Staten, 61350
- Illinois CancerCare-Ottawa Clinic
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Palos Heights, Illinois, Verenigde Staten, 60463
- Advocate High Tech Medical Park
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Park Ridge, Illinois, Verenigde Staten, 60068
- Advocate Lutheran General Hospital
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Pekin, Illinois, Verenigde Staten, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Verenigde Staten, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Verenigde Staten, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Verenigde Staten, 61356
- Illinois CancerCare-Princeton
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Shiloh, Illinois, Verenigde Staten, 62269
- Memorial Hospital East
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Springfield, Illinois, Verenigde Staten, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Verenigde Staten, 62702
- Springfield Clinic
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Springfield, Illinois, Verenigde Staten, 62781
- Springfield Memorial Hospital
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Washington, Illinois, Verenigde Staten, 61571
- Illinois CancerCare - Washington
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46237
- Franciscan Health Indianapolis
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Verenigde Staten, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Bettendorf, Iowa, Verenigde Staten, 52722
- University of Iowa Healthcare Cancer Services Quad Cities
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Boone, Iowa, Verenigde Staten, 50036
- McFarland Clinic - Boone
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Carroll, Iowa, Verenigde Staten, 51401
- Saint Anthony Regional Hospital
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Verenigde Staten, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Verenigde Staten, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Verenigde Staten, 50501
- McFarland Clinic - Trinity Cancer Center
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Fort Dodge, Iowa, Verenigde Staten, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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Iowa City, Iowa, Verenigde Staten, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Jefferson, Iowa, Verenigde Staten, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Verenigde Staten, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Verenigde Staten, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, Verenigde Staten, 66210
- University of Kansas Cancer Center-Overland Park
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Overland Park, Kansas, Verenigde Staten, 66211
- University of Kansas Hospital-Indian Creek Campus
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Westwood, Kansas, Verenigde Staten, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, Verenigde Staten, 40202
- The James Graham Brown Cancer Center at University of Louisville
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Maine
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Brewer, Maine, Verenigde Staten, 04412
- Lafayette Family Cancer Center-EMMC
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Scarborough, Maine, Verenigde Staten, 04074
- MaineHealth Maine Medical Center- Scarborough
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South Portland, Maine, Verenigde Staten, 04106
- MaineHealth Cancer Care and IV Therapy - South Portland
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan Rogel Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brighton, Michigan, Verenigde Staten, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Verenigde Staten, 48116
- University of Michigan - Brighton Center for Specialty Care
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Canton, Michigan, Verenigde Staten, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Chelsea, Michigan, Verenigde Staten, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital
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Escanaba, Michigan, Verenigde Staten, 49829
- OSF Saint Francis Hospital and Medical Group
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Verenigde Staten, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Verenigde Staten, 48503
- Cancer Hematology Centers - Flint
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Lansing, Michigan, Verenigde Staten, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Verenigde Staten, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Ypsilanti, Michigan, Verenigde Staten, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Minnesota
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Bemidji, Minnesota, Verenigde Staten, 56601
- Sanford Joe Lueken Cancer Center
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Brainerd, Minnesota, Verenigde Staten, 56401
- Essentia Health Saint Joseph's Medical Center
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy Hospital
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Deer River, Minnesota, Verenigde Staten, 56636
- Essentia Health - Deer River Clinic
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Duluth, Minnesota, Verenigde Staten, 55805
- Essentia Health Cancer Center
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Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
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Hibbing, Minnesota, Verenigde Staten, 55746
- Essentia Health Hibbing Clinic
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital
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Saint Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
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Sandstone, Minnesota, Verenigde Staten, 55072
- Essentia Health Sandstone
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Virginia, Minnesota, Verenigde Staten, 55792
- Essentia Health Virginia Clinic
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Mississippi
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Columbus, Mississippi, Verenigde Staten, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
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Grenada, Mississippi, Verenigde Staten, 38901
- Baptist Cancer Center-Grenada
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New Albany, Mississippi, Verenigde Staten, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
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Oxford, Mississippi, Verenigde Staten, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Southhaven, Mississippi, Verenigde Staten, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
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Missouri
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Cape Girardeau, Missouri, Verenigde Staten, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Verenigde Staten, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Verenigde Staten, 63141
- Siteman Cancer Center at West County Hospital
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St Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
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St Louis, Missouri, Verenigde Staten, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Verenigde Staten, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Verenigde Staten, 63128
- Mercy Hospital South
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Montana
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Anaconda, Montana, Verenigde Staten, 59711
- Community Hospital of Anaconda
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Billings, Montana, Verenigde Staten, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Verenigde Staten, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Verenigde Staten, 59901
- Logan Health Medical Center
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Missoula, Montana, Verenigde Staten, 59804
- Community Medical Center
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Nebraska
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Bellevue, Nebraska, Verenigde Staten, 68123
- Nebraska Medicine-Bellevue
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Omaha, Nebraska, Verenigde Staten, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, Verenigde Staten, 68118
- Nebraska Medicine-Village Pointe
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Nevada
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Reno, Nevada, Verenigde Staten, 89502
- Renown Regional Medical Center
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Camden, New Jersey, Verenigde Staten, 08103
- Cooper Hospital University Medical Center
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Edison, New Jersey, Verenigde Staten, 08818
- John F Kennedy Medical Center
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Hackensack, New Jersey, Verenigde Staten, 07601
- Hackensack University Medical Center
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Jersey City, New Jersey, Verenigde Staten, 07302
- Jersey City Medical Center
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Livingston, New Jersey, Verenigde Staten, 07039
- Cooperman Barnabas Medical Center
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Long Branch, New Jersey, Verenigde Staten, 07740
- Monmouth Medical Center
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Morristown, New Jersey, Verenigde Staten, 07960
- Morristown Medical Center
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Neptune City, New Jersey, Verenigde Staten, 07753
- Jersey Shore Medical Center
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New Brunswick, New Jersey, Verenigde Staten, 08903
- Rutgers Cancer Institute of New Jersey
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Newark, New Jersey, Verenigde Staten, 07112
- Newark Beth Israel Medical Center
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Sewell, New Jersey, Verenigde Staten, 08080
- Sidney Kimmel Cancer Center Washington Township
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Summit, New Jersey, Verenigde Staten, 07902
- Overlook Hospital
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Toms River, New Jersey, Verenigde Staten, 08755
- Community Medical Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87106
- University of New Mexico Cancer Center
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Albuquerque, New Mexico, Verenigde Staten, 87110
- Presbyterian Kaseman Hospital
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Rio Rancho, New Mexico, Verenigde Staten, 87124
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
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New York
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Bay Shore, New York, Verenigde Staten, 11706
- Northwell Health Imbert Cancer Center
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Brooklyn, New York, Verenigde Staten, 11220
- NYU Langone Hospital - Brooklyn
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Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
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Glens Falls, New York, Verenigde Staten, 12801
- Glens Falls Hospital
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Lake Success, New York, Verenigde Staten, 11042
- Northwell Health/Center for Advanced Medicine
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Mineola, New York, Verenigde Staten, 11501
- NYU Langone Hospital - Long Island
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New York, New York, Verenigde Staten, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New York, New York, Verenigde Staten, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Oswego, New York, Verenigde Staten, 13126
- Upstate Cancer Center at Oswego
-
Rochester, New York, Verenigde Staten, 14642
- University of Rochester
-
Syracuse, New York, Verenigde Staten, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Verenigde Staten, 10461
- Montefiore Medical Center-Einstein Campus
-
-
North Carolina
-
Pinehurst, North Carolina, Verenigde Staten, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Verenigde Staten, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Verenigde Staten, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Verenigde Staten, 58103
- Essentia Health Cancer Center-South University Clinic
-
Fargo, North Dakota, Verenigde Staten, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Centerville, Ohio, Verenigde Staten, 45459
- Miami Valley Hospital South
-
Cincinnati, Ohio, Verenigde Staten, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Verenigde Staten, 45220
- Good Samaritan Hospital - Cincinnati
-
Columbus, Ohio, Verenigde Staten, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Verenigde Staten, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Verenigde Staten, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Verenigde Staten, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Verenigde Staten, 45409
- Premier Blood and Cancer Center
-
Franklin, Ohio, Verenigde Staten, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, Verenigde Staten, 45331
- Miami Valley Cancer Care and Infusion
-
Troy, Ohio, Verenigde Staten, 45373
- Upper Valley Medical Center
-
West Chester, Ohio, Verenigde Staten, 45069
- University of Cincinnati Cancer Center-West Chester
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Verenigde Staten, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Gresham, Oregon, Verenigde Staten, 97030
- Legacy Mount Hood Medical Center
-
Ontario, Oregon, Verenigde Staten, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Portland, Oregon, Verenigde Staten, 97239
- Oregon Health and Science University
-
Portland, Oregon, Verenigde Staten, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Portland, Oregon, Verenigde Staten, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Verenigde Staten, 97225
- Providence Saint Vincent Medical Center
-
Tualatin, Oregon, Verenigde Staten, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Verenigde Staten, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Verenigde Staten, 18017
- Lehigh Valley Hospital - Muhlenberg
-
East Stroudsburg, Pennsylvania, Verenigde Staten, 18301
- Pocono Medical Center
-
Erie, Pennsylvania, Verenigde Staten, 16505
- UPMC Hillman Cancer Center Erie
-
Erie, Pennsylvania, Verenigde Staten, 16544
- Saint Vincent Hospital
-
Jefferson Hills, Pennsylvania, Verenigde Staten, 15025
- Jefferson Hospital
-
Monroeville, Pennsylvania, Verenigde Staten, 15146
- Forbes Hospital
-
Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Thomas Jefferson University Hospital
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15212
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- UPMC Hillman Cancer Center
-
Wexford, Pennsylvania, Verenigde Staten, 15090
- Wexford Health and Wellness Pavilion
-
-
South Carolina
-
Charleston, South Carolina, Verenigde Staten, 29425
- Medical University of South Carolina
-
-
South Dakota
-
Sioux Falls, South Dakota, Verenigde Staten, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Verenigde Staten, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Collierville, Tennessee, Verenigde Staten, 38017
- Baptist Memorial Hospital and Cancer Center-Collierville
-
Memphis, Tennessee, Verenigde Staten, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Verenigde Staten, 84112
- Huntsman Cancer Institute/University of Utah
-
-
Vermont
-
Burlington, Vermont, Verenigde Staten, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Verenigde Staten, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Fairfax, Virginia, Verenigde Staten, 22031
- Inova Schar Cancer Institute
-
Mechanicsville, Virginia, Verenigde Staten, 23116
- Bon Secours Memorial Regional Medical Center
-
Midlothian, Virginia, Verenigde Staten, 23114
- Bon Secours Saint Francis Medical Center
-
Richmond, Virginia, Verenigde Staten, 23226
- Bon Secours Saint Mary's Hospital
-
Richmond, Virginia, Verenigde Staten, 23223
- Bon Secours Richmond Community Hospital
-
Richmond, Virginia, Verenigde Staten, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Seattle, Washington, Verenigde Staten, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Vancouver, Washington, Verenigde Staten, 98686
- Legacy Salmon Creek Hospital
-
Vancouver, Washington, Verenigde Staten, 98684
- Legacy Cancer Institute Medical Oncology and Day Treatment
-
-
West Virginia
-
Morgantown, West Virginia, Verenigde Staten, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Verenigde Staten, 26101
- Camden Clark Medical Center
-
Wheeling, West Virginia, Verenigde Staten, 26003
- Wheeling Hospital/Schiffler Cancer Center
-
-
Wisconsin
-
Ashland, Wisconsin, Verenigde Staten, 54806
- Duluth Clinic Ashland
-
Burlington, Wisconsin, Verenigde Staten, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Cudahy, Wisconsin, Verenigde Staten, 53110
- Aurora Saint Luke's South Shore
-
Eau Claire, Wisconsin, Verenigde Staten, 54701
- Marshfield Medical Center-EC Cancer Center
-
Germantown, Wisconsin, Verenigde Staten, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Verenigde Staten, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Verenigde Staten, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, Verenigde Staten, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Verenigde Staten, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Janesville, Wisconsin, Verenigde Staten, 53548
- Mercyhealth Hospital and Cancer Center - Janesville
-
Kenosha, Wisconsin, Verenigde Staten, 53142
- Aurora Cancer Care-Kenosha South
-
Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Madison, Wisconsin, Verenigde Staten, 53718
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
-
Marinette, Wisconsin, Verenigde Staten, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Verenigde Staten, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Verenigde Staten, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Verenigde Staten, 53233
- Aurora Sinai Medical Center
-
Mukwonago, Wisconsin, Verenigde Staten, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, Verenigde Staten, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Verenigde Staten, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, Verenigde Staten, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, Verenigde Staten, 53406
- Aurora Cancer Care-Racine
-
Sheboygan, Wisconsin, Verenigde Staten, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sheboygan, Wisconsin, Verenigde Staten, 53081
- Saint Vincent Hospital Cancer Center at Sheboygan
-
Sheboygan, Wisconsin, Verenigde Staten, 53081
- Sheboygan Physicians Group
-
Stevens Point, Wisconsin, Verenigde Staten, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Sturgeon Bay, Wisconsin, Verenigde Staten, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, Verenigde Staten, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Verenigde Staten, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, Verenigde Staten, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Verenigde Staten, 53188
- ProHealth Waukesha Memorial Hospital
-
Wauwatosa, Wisconsin, Verenigde Staten, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Verenigde Staten, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Verenigde Staten, 54476
- Marshfield Medical Center - Weston
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm I (nivolumab, 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
Andere namen:
Undergo MRI
Andere namen:
Undergo biopsy
Andere namen:
Given IV
Andere namen:
Given IV
Andere namen:
Undergo surgery
Andere namen:
|
|
Actieve vergelijker: 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
Andere namen:
Undergo MRI
Andere namen:
Undergo biopsy
Andere namen:
Undergo surgery
Andere namen:
Given PO
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progressievrije overleving
Tijdsspanne: Van randomisatie tot bevestigde ziekteprogressie zoals beoordeeld door de behandelend arts of overlijden als gevolg van enige oorzaak, afhankelijk van wat zich eerst voordoet, tot 5 jaar beoordeeld
|
Van randomisatie tot bevestigde ziekteprogressie zoals beoordeeld door de behandelend arts of overlijden als gevolg van enige oorzaak, afhankelijk van wat zich eerst voordoet, tot 5 jaar beoordeeld
|
|
|
Radiographic response
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Michael Lim, Alliance for Clinical Trials in Oncology
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 november 2024
Primaire voltooiing (Geschat)
15 juli 2029
Studie voltooiing (Geschat)
15 juli 2029
Studieregistratiedata
Eerst ingediend
20 maart 2024
Eerst ingediend dat voldeed aan de QC-criteria
20 maart 2024
Eerst geplaatst (Werkelijk)
22 maart 2024
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 november 2026
Laatste update ingediend die voldeed aan QC-criteria
31 oktober 2026
Laatst geverifieerd
1 oktober 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Neoplasmata per histologisch type
- Neoplasmata, glandulair en epitheel
- Astrocytoom
- Glioom
- Neoplasmata, neuro-epitheliaal
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Glioblastoom
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Zwavelverbindingen
- Organische chemicaliën
- Onderzoekstechnieken
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Cytologische technieken
- Cytodiagnose
- Amides
- Antilichamen, monoklonaal, gehumaniseerd
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Anorganische chemicaliën
- Diagnostische technieken, chirurgisch
- Chemie -technieken, analytisch
- Spectrumanalyse
- Immunoglobuline -isotypes
- Sulfiden
- Anionen
- Ionen
- Elektrolyten
- Waterstofsulfide
- Nitrosoureumverbindingen
- Ureum
- Nitroso -verbindingen
- Nivolumab
- Immunoglobuline G
- Lomustine
- Biopsie
- Exemplaarbehandeling
- Magnetische resonantiespectroscopie
- Disulfides
- Chirurgische procedures, operatief
- relatlimab
Andere studie-ID-nummers
- NCI-2024-01995
- U10CA180821 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2024-01995 (Register-ID: CTRP (Clinical Trial Reporting Program))
- A072201 (Andere identificatie: CTEP)
- A072201 (Andere identificatie: Alliance for Clinical Trials in Oncology)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .