- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04145115
En undersøgelse, der tester effekten af immunterapi (Ipilimumab og Nivolumab) hos patienter med tilbagevendende gliom med forhøjet mutationsbyrde
Et fase II-studie af checkpoint-blokade-immunterapi hos patienter med somatisk hypermuteret tilbagevendende WHO grad 4-gliom
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMÆR MÅL:
I. For at bestemme, om kombinationen af ipilimumab og nivolumab øger tumorresponsraten vurderet ved modificeret Respons Assessment in Neuro-Oncology (RANO) Criteria hos patienter med hypermuteret tilbagevendende glioblastom.
SEKUNDÆRE MÅL:
I. Estimer den samlede overlevelsesfordeling, median overlevelse og et-års overlevelsesrate for patienter med hypermuteret, tilbagevendende glioblastom, som behandles med ipilimumab og nivolumab.
II. Estimer den progressionsfrie overlevelsesfordeling og median progressionsfri overlevelse for patienter med hypermuteret, tilbagevendende glioblastom, som behandles med ipilimumab og nivolumab.
III. Bestem bivirkningsprofilen for patienter med hypermuteret, tilbagevendende glioblastom, som behandles med ipilimumab og nivolumab.
UNDERSØGENDE MÅL:
I. Test, om PD-L1 eller immunologisk infiltrat i tumormikromiljøet er associeret med objektiv tumorrespons, generel overlevelse, progressionsfri overlevelse, tumormutationsbyrde eller frekvenser af grad 3 eller højere bivirkninger.
II. Test, om MGMT-status, mikrosatellit-instabilitet (MSI)-status, mutationssignaturer eller mængden af tumormutationsbyrde (TMB) inklusive kimlinjeanalyse er forbundet med objektiv tumorrespons, samlet overlevelse, progressionsfri overlevelse eller rater på grad 3 eller højere uønskede begivenheder.
III. Evaluer sammenhænge mellem exom- og transkriptom-genniveauer med objektiv tumorrespons, samlet overlevelse, progressionsfri overlevelse, rater af grad 3 eller højere bivirkninger.
IV. Evaluer sammenhænge mellem tarmmikrobiomet og objektiv tumorrespons.
V. Responsrate ved anvendelse af immunterapi (i)RANO.
OMRIDS:
Patienterne får nivolumab intravenøst (IV) over 30 minutter og ipilimumab IV over 30 minutter på dag 1. Behandlingen gentages hver 3. uge i 4 cyklusser i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienterne får derefter nivolumab IV over 30 minutter på dag 1. Cykler gentages hver 4. uge i fravær af sygdomsprogression eller uacceptabel toksicitet.
Efter afsluttet undersøgelsesbehandling følges patienter uden sygdomsprogression hver 8. uge indtil sygdomsprogression, derefter hver 3. måned i op til 3 år. Patienter med sygdomsprogression efter afslutning af undersøgelsesbehandling følges hver 3. måned i op til 3 år.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Alaska
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Anchorage, Alaska, Forenede Stater, 98508
- Anchorage Associates in Radiation Medicine
-
Anchorage, Alaska, Forenede Stater, 99508
- Alaska Breast Care and Surgery LLC
-
Anchorage, Alaska, Forenede Stater, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, Forenede Stater, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Forenede Stater, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, Forenede Stater, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Forenede Stater, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Hospital in Arizona
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Phoenix, Arizona, Forenede Stater, 85004
- Cancer Center at Saint Joseph's
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic in Arizona
-
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Arkansas
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Fort Smith, Arkansas, Forenede Stater, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Forenede Stater, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Forenede Stater, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Carmichael, California, Forenede Stater, 95608
- Mercy San Juan Medical Center
-
Carmichael, California, Forenede Stater, 95608
- Mercy Cancer Center - Carmichael
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Elk Grove, California, Forenede Stater, 95758
- Mercy Cancer Center - Elk Grove
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La Jolla, California, Forenede Stater, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
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Rocklin, California, Forenede Stater, 95765
- Mercy Cancer Center - Rocklin
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Comprehensive Cancer Center
-
Sacramento, California, Forenede Stater, 95816
- Mercy Cancer Center - Sacramento
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San Luis Obispo, California, Forenede Stater, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Forenede Stater, 93444
- Mission Hope Medical Oncology - Santa Maria
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Torrance, California, Forenede Stater, 90509
- Torrance Memorial Medical Center
-
Torrance, California, Forenede Stater, 90505
- Torrance Memorial Physician Network - Cancer Care
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Woodland, California, Forenede Stater, 95695
- Woodland Memorial Hospital
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- UCHealth University of Colorado Hospital
-
Boulder, Colorado, Forenede Stater, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Forenede Stater, 80210
- AdventHealth Porter
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Durango, Colorado, Forenede Stater, 81301
- Mercy Medical Center
-
Durango, Colorado, Forenede Stater, 81301
- CommonSpirit Cancer Center Mercy
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Lakewood, Colorado, Forenede Stater, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Forenede Stater, 80122
- AdventHealth Littleton
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Longmont, Colorado, Forenede Stater, 80501
- Longmont United Hospital
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Longmont, Colorado, Forenede Stater, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Forenede Stater, 80138
- AdventHealth Parker
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Pueblo, Colorado, Forenede Stater, 81004
- Saint Mary Corwin Medical Center
-
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Delaware
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Lewes, Delaware, Forenede Stater, 19958
- Beebe Medical Center
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Millville, Delaware, Forenede Stater, 19967
- Beebe South Coastal Health Campus
-
Newark, Delaware, Forenede Stater, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Forenede Stater, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, Forenede Stater, 19713
- Medical Oncology Hematology Consultants PA
-
Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach, Delaware, Forenede Stater, 19971
- Beebe Health Campus
-
Seaford, Delaware, Forenede Stater, 19973
- TidalHealth Nanticoke / Allen Cancer Center
-
Wilmington, Delaware, Forenede Stater, 19801
- Christiana Care Health System-Wilmington Hospital
-
-
Florida
-
Fort Lauderdale, Florida, Forenede Stater, 33308
- Holy Cross Hospital
-
Jacksonville, Florida, Forenede Stater, 32224-9980
- Mayo Clinic in Florida
-
-
Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital/Winship Cancer Institute
-
Savannah, Georgia, Forenede Stater, 31404
- Memorial Health University Medical Center
-
Savannah, Georgia, Forenede Stater, 31404
- Low Country Cancer Care
-
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Idaho
-
Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
-
Caldwell, Idaho, Forenede Stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Health - Coeur d'Alene
-
Emmett, Idaho, Forenede Stater, 83617
- Walter Knox Memorial Hospital
-
Fruitland, Idaho, Forenede Stater, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, Forenede Stater, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, Forenede Stater, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa, Idaho, Forenede Stater, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, Forenede Stater, 83864
- Kootenai Clinic Cancer Services - Sandpoint
-
Twin Falls, Idaho, Forenede Stater, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
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Illinois
-
Alton, Illinois, Forenede Stater, 62002
- OSF Saint Anthony's Health Center
-
Aurora, Illinois, Forenede Stater, 60504
- Rush-Copley Medical Center
-
Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, Forenede Stater, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, Forenede Stater, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Forenede Stater, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
-
Danville, Illinois, Forenede Stater, 61832
- Carle at The Riverfront
-
Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Forenede Stater, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, Forenede Stater, 62401
- Carle Physician Group-Effingham
-
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
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
-
Glenview, Illinois, Forenede Stater, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
-
Highland Park, Illinois, Forenede Stater, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, Forenede Stater, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, Forenede Stater, 62864
- SSM Health Good Samaritan
-
O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, Forenede Stater, 61554
- OSF Saint Francis Radiation Oncology at Pekin
-
Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Forenede Stater, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Forenede Stater, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
-
Skokie, Illinois, Forenede Stater, 60076
- North Shore Medical Center
-
Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
-
Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
-
Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center
-
Urbana, Illinois, Forenede Stater, 61801
- The Carle Foundation Hospital
-
Washington, Illinois, Forenede Stater, 61571
- Illinois CancerCare - Washington
-
Yorkville, Illinois, Forenede Stater, 60560
- Rush-Copley Healthcare Center
-
-
Indiana
-
New Albany, Indiana, Forenede Stater, 47150
- Baptist Health Floyd
-
-
Iowa
-
Ames, Iowa, Forenede Stater, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic - Ames
-
Boone, Iowa, Forenede Stater, 50036
- McFarland Clinic - Boone
-
Carroll, Iowa, Forenede Stater, 51401
- Saint Anthony Regional Hospital
-
Clive, Iowa, Forenede Stater, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Alegent Health Mercy Hospital
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Heartland Oncology and Hematology LLP
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Methodist Jennie Edmundson Hospital
-
Creston, Iowa, Forenede Stater, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forenede Stater, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, Forenede Stater, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Forenede Stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge, Iowa, Forenede Stater, 50501
- McFarland Clinic - Trinity Cancer Center
-
Fort Dodge, Iowa, Forenede Stater, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
-
Jefferson, Iowa, Forenede Stater, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Forenede Stater, 50158
- McFarland Clinic - Marshalltown
-
West Des Moines, Iowa, Forenede Stater, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, Forenede Stater, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas - Chanute
-
Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas - El Dorado
-
Garden City, Kansas, Forenede Stater, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, Forenede Stater, 67530
- Central Care Cancer Center - Great Bend
-
Independence, Kansas, Forenede Stater, 67301
- Cancer Center of Kansas-Independence
-
Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas-Kingman
-
Liberal, Kansas, Forenede Stater, 67905
- Cancer Center of Kansas-Liberal
-
Manhattan, Kansas, Forenede Stater, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, Forenede Stater, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas - Newton
-
Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Forenede Stater, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, Forenede Stater, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas - Wichita
-
Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas - Winfield
-
-
Kentucky
-
Bardstown, Kentucky, Forenede Stater, 40004
- Flaget Memorial Hospital
-
Corbin, Kentucky, Forenede Stater, 40701
- Commonwealth Cancer Center-Corbin
-
Lexington, Kentucky, Forenede Stater, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Forenede Stater, 40509
- Saint Joseph Hospital East
-
Lexington, Kentucky, Forenede Stater, 40503
- Baptist Health Lexington
-
London, Kentucky, Forenede Stater, 40741
- Saint Joseph London
-
Louisville, Kentucky, Forenede Stater, 40202
- Jewish Hospital
-
Louisville, Kentucky, Forenede Stater, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, Forenede Stater, 40207
- Baptist Health Louisville
-
Louisville, Kentucky, Forenede Stater, 40215
- Saints Mary and Elizabeth Hospital
-
Shepherdsville, Kentucky, Forenede Stater, 40165
- Jewish Hospital Medical Center South
-
-
Louisiana
-
Monroe, Louisiana, Forenede Stater, 71202
- Ochsner LSU Health Monroe Medical Center
-
Shreveport, Louisiana, Forenede Stater, 71103
- LSU Health Sciences Center at Shreveport
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek, Michigan, Forenede Stater, 49017
- Bronson Battle Creek
-
Brighton, Michigan, Forenede Stater, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brighton, Michigan, Forenede Stater, 48114
- Trinity Health Medical Center - Brighton
-
Canton, Michigan, Forenede Stater, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Canton, Michigan, Forenede Stater, 48188
- Trinity Health Medical Center - Canton
-
Caro, Michigan, Forenede Stater, 48723
- Caro Cancer Center
-
Chelsea, Michigan, Forenede Stater, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Chelsea, Michigan, Forenede Stater, 48118
- Chelsea Hospital
-
Clarkston, Michigan, Forenede Stater, 48346
- Hematology Oncology Consultants-Clarkston
-
Clarkston, Michigan, Forenede Stater, 48346
- Newland Medical Associates-Clarkston
-
Detroit, Michigan, Forenede Stater, 48236
- Henry Ford Health Saint John Hospital
-
East China Township, Michigan, Forenede Stater, 48054
- Henry Ford River District Hospital
-
Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forenede Stater, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
-
Flint, Michigan, Forenede Stater, 48503
- Cancer Hematology Centers - Flint
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Henry Ford Saint John Hospital - Academic
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Henry Ford Saint John Hospital - Breast
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Henry Ford Saint John Hospital - Van Elslander
-
Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Forenede Stater, 49009
- Beacon Kalamazoo Cancer Center
-
Kalamazoo, Michigan, Forenede Stater, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Forenede Stater, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Forenede Stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Livonia, Michigan, Forenede Stater, 48154
- Hope Cancer Clinic
-
Macomb, Michigan, Forenede Stater, 48044
- Henry Ford Warren Hospital - Breast Macomb
-
Macomb, Michigan, Forenede Stater, 48044
- Henry Ford Saint John Hospital - Macomb Medical
-
Marlette, Michigan, Forenede Stater, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Muskegon, Michigan, Forenede Stater, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Forenede Stater, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores, Michigan, Forenede Stater, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Pontiac, Michigan, Forenede Stater, 48341
- Hope Cancer Center
-
Pontiac, Michigan, Forenede Stater, 48341
- Newland Medical Associates-Pontiac
-
Pontiac, Michigan, Forenede Stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Pontiac, Michigan, Forenede Stater, 48341
- Michigan Healthcare Professionals Pontiac
-
Reed City, Michigan, Forenede Stater, 49677
- Corewell Health Reed City Hospital
-
Rochester Hills, Michigan, Forenede Stater, 48309
- Henry Ford Rochester Hospital
-
Royal Oak, Michigan, Forenede Stater, 48073
- Corewell Health William Beaumont University Hospital
-
Saginaw, Michigan, Forenede Stater, 48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Saginaw, Michigan, Forenede Stater, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Sterling Heights, Michigan, Forenede Stater, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Tawas City, Michigan, Forenede Stater, 48764
- MyMichigan Medical Center Tawas
-
Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
-
Troy, Michigan, Forenede Stater, 48085
- Corewell Health Beaumont Troy Hospital
-
Warren, Michigan, Forenede Stater, 48088
- Advanced Breast Care Center PLLC
-
Warren, Michigan, Forenede Stater, 48093
- Macomb Hematology Oncology PC
-
Warren, Michigan, Forenede Stater, 48093
- Henry Ford Madison Heights Hospital - Breast
-
Warren, Michigan, Forenede Stater, 48093
- Henry Ford Health Warren Hospital
-
Warren, Michigan, Forenede Stater, 48093
- Henry Ford Warren Hospital - GLCMS
-
West Branch, Michigan, Forenede Stater, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Wyoming, Michigan, Forenede Stater, 49519
- University of Michigan Health - West
-
Ypsilanti, Michigan, Forenede Stater, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, Forenede Stater, 48106
- Huron Gastroenterology PC
-
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Minnesota
-
Bemidji, Minnesota, Forenede Stater, 56601
- Sanford Joe Lueken Cancer Center
-
Brainerd, Minnesota, Forenede Stater, 56401
- Essentia Health Saint Joseph's Medical Center
-
Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, Forenede Stater, 55337
- Minnesota Oncology - Burnsville
-
Cambridge, Minnesota, Forenede Stater, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
-
Deer River, Minnesota, Forenede Stater, 56636
- Essentia Health - Deer River Clinic
-
Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Cancer Center
-
Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Forenede Stater, 55432
- Unity Hospital
-
Hibbing, Minnesota, Forenede Stater, 55746
- Essentia Health Hibbing Clinic
-
Maple Grove, Minnesota, Forenede Stater, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Forenede Stater, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Forenede Stater, 55454
- Health Partners Inc
-
Monticello, Minnesota, Forenede Stater, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, Forenede Stater, 56073
- New Ulm Medical Center
-
Princeton, Minnesota, Forenede Stater, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, Forenede Stater, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
-
Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
-
Sandstone, Minnesota, Forenede Stater, 55072
- Essentia Health Sandstone
-
Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Forenede Stater, 55082
- Lakeview Hospital
-
Thief River Falls, Minnesota, Forenede Stater, 56701
- Sanford Thief River Falls Medical Center
-
Virginia, Minnesota, Forenede Stater, 55792
- Essentia Health Virginia Clinic
-
Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Forenede Stater, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Worthington, Minnesota, Forenede Stater, 56187
- Sanford Cancer Center Worthington
-
Wyoming, Minnesota, Forenede Stater, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Ballwin, Missouri, Forenede Stater, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Forenede Stater, 65613
- Central Care Cancer Center - Bolivar
-
Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Forenede Stater, 63703
- Mercy Cancer Center - Cape Girardeau
-
Creve Coeur, Missouri, Forenede Stater, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Forenede Stater, 63640
- Parkland Health Center - Farmington
-
Jefferson City, Missouri, Forenede Stater, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Forenede Stater, 64804
- Freeman Health System
-
Joplin, Missouri, Forenede Stater, 64804
- Mercy Hospital Joplin
-
Rolla, Missouri, Forenede Stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Forenede Stater, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Forenede Stater, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Forenede Stater, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Forenede Stater, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Forenede Stater, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Forenede Stater, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Forenede Stater, 63080
- Missouri Baptist Sullivan Hospital
-
Sunset Hills, Missouri, Forenede Stater, 63127
- BJC Outpatient Center at Sunset Hills
-
Washington, Missouri, Forenede Stater, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, Forenede Stater, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, Forenede Stater, 59901
- Logan Health Medical Center
-
Missoula, Montana, Forenede Stater, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Forenede Stater, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Forenede Stater, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Forenede Stater, 68847
- CHI Health Good Samaritan
-
Lincoln, Nebraska, Forenede Stater, 68510
- Saint Elizabeth Regional Medical Center
-
Lincoln, Nebraska, Forenede Stater, 68516
- Cancer Partners of Nebraska
-
Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Forenede Stater, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Forenede Stater, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Forenede Stater, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Forenede Stater, 68131
- Creighton University Medical Center
-
Omaha, Nebraska, Forenede Stater, 68114
- Oncology Associates PC
-
Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
-
Papillion, Nebraska, Forenede Stater, 68046
- Midlands Community Hospital
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Morristown, New Jersey, Forenede Stater, 07960
- Morristown Medical Center
-
Neptune City, New Jersey, Forenede Stater, 07753
- Jersey Shore Medical Center
-
Pennington, New Jersey, Forenede Stater, 08534
- Capital Health Medical Center-Hopewell
-
Summit, New Jersey, Forenede Stater, 07902
- Overlook Hospital
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
-
North Carolina
-
Asheboro, North Carolina, Forenede Stater, 27203
- Randolph Hospital
-
Asheville, North Carolina, Forenede Stater, 28806
- Messino Cancer Centers
-
Burlington, North Carolina, Forenede Stater, 27215
- Cone Health Cancer Center at Alamance Regional
-
Greensboro, North Carolina, Forenede Stater, 27403
- Cone Health Cancer Center
-
Greensboro, North Carolina, Forenede Stater, 27410
- Cone Health Cancer Center at Drawbridge Parkway
-
Greenville, North Carolina, Forenede Stater, 27834
- ECU Health Medical Center
-
Mebane, North Carolina, Forenede Stater, 27302
- Cone Heath Cancer Center at Mebane
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Sanford Bismarck Medical Center
-
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
-
Fargo, North Dakota, Forenede Stater, 58103
- Sanford South University Medical Center
-
Fargo, North Dakota, Forenede Stater, 58103
- Southpointe-Sanford Medical Center Fargo
-
Fargo, North Dakota, Forenede Stater, 58104
- Sanford Medical Center Fargo
-
-
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
-
Cincinnati, Ohio, Forenede Stater, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Forenede Stater, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Forenede Stater, 45255
- TriHealth Cancer Institute-Anderson
-
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, 45415
- Dayton Physician LLC - Englewood
-
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
-
Kettering, Ohio, Forenede Stater, 45429
- Kettering Medical Center
-
Kettering, Ohio, Forenede Stater, 45409
- Greater Dayton Cancer Center
-
Troy, Ohio, Forenede Stater, 45373
- Upper Valley Medical Center
-
West Chester, Ohio, Forenede Stater, 45069
- University of Cincinnati Cancer Center-West Chester
-
-
Oklahoma
-
Lawton, Oklahoma, Forenede Stater, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forenede Stater, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Baker City, Oregon, Forenede Stater, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Forenede Stater, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Forenede Stater, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Forenede Stater, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Forenede Stater, 97420
- Bay Area Hospital
-
Newberg, Oregon, Forenede Stater, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Forenede Stater, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Forenede Stater, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Forenede Stater, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Chadds Ford, Pennsylvania, Forenede Stater, 19317
- Christiana Care Health System-Concord Health Center
-
East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Medical Center
-
Hazleton, Pennsylvania, Forenede Stater, 18201
- Lehigh Valley Hospital-Hazleton
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
West Reading, Pennsylvania, Forenede Stater, 19611
- Reading Hospital
-
-
South Carolina
-
Greer, South Carolina, Forenede Stater, 29651
- Gibbs Cancer Center-Pelham
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Center
-
-
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
-
-
Texas
-
Bryan, Texas, Forenede Stater, 77802
- Saint Joseph Regional Cancer Center
-
Dallas, Texas, Forenede Stater, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute/University of Utah
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Inova Schar Cancer Institute
-
Falls Church, Virginia, Forenede Stater, 22042
- Inova Fairfax Hospital
-
-
Washington
-
Aberdeen, Washington, Forenede Stater, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellingham, Washington, Forenede Stater, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, Forenede Stater, 98166
- Highline Medical Center-Main Campus
-
Centralia, Washington, Forenede Stater, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Forenede Stater, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, Forenede Stater, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, Forenede Stater, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, Forenede Stater, 98003
- Saint Francis Hospital
-
Issaquah, Washington, Forenede Stater, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Forenede Stater, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Forenede Stater, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, Forenede Stater, 98499
- Saint Clare Hospital
-
Longview, Washington, Forenede Stater, 98632
- PeaceHealth Saint John Medical Center
-
Port Townsend, Washington, Forenede Stater, 98368
- Jefferson Healthcare
-
Poulsbo, Washington, Forenede Stater, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle, Washington, Forenede Stater, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Forenede Stater, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Forenede Stater, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Forenede Stater, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Forenede Stater, 98584
- Providence Regional Cancer System-Shelton
-
Silverdale, Washington, Forenede Stater, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Tacoma, Washington, Forenede Stater, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Forenede Stater, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, Forenede Stater, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Forenede Stater, 99362
- Providence Saint Mary Regional Cancer Center
-
Yelm, Washington, Forenede Stater, 98597
- Providence Regional Cancer System-Yelm
-
-
West Virginia
-
Bridgeport, West Virginia, Forenede Stater, 26330
- United Hospital Center
-
Martinsburg, West Virginia, Forenede Stater, 25401
- WVUH-Berkely Medical Center
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Forenede Stater, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Ashland, Wisconsin, Forenede Stater, 54806
- Duluth Clinic Ashland
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Mayo Clinic Health System-Eau Claire Clinic
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Center
-
Mukwonago, Wisconsin, Forenede Stater, 53149
- ProHealth D N Greenwald Center
-
New Richmond, Wisconsin, Forenede Stater, 54017
- Cancer Center of Western Wisconsin
-
Oconomowoc, Wisconsin, Forenede Stater, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Waukesha, Wisconsin, Forenede Stater, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Forenede Stater, 53188
- ProHealth Waukesha Memorial Hospital
-
-
Wyoming
-
Cody, Wyoming, Forenede Stater, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center
-
-
-
-
-
San Juan, Puerto Rico, 00902
- Pan American Center for Oncology Trials LLC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- KRITERIER FOR KVALIFIKATION AF FORREGISTRERING:
Histologisk bekræftet glioblastom (World Health Organization [WHO] grad IV), der viser sig ved første eller anden recidiv inklusive sekundær glioblastom
Glioblastom IDH-vildtype centralnervesystem (CNS) WHO grad 4
- Diffus, astrocytisk gliom IDH-vildtype med en eller flere af følgende histologiske eller genetiske træk: mikrovaskulær proliferation, nekrose, TERT-promotormutation, EGFR-genamplifikation, +7/-10 ændringer i kromosomkopinummer
Astrocytom, IDH-mutant CNS WHO grad 4
- Diffus astrocytisk gliom IDH-mutant (med hyppig ATRX- og/eller TP53-mutation og fravær af 1p/19q-kodeletion), med nekrose og/eller mikrovaskulær proliferation eller en med histologiske træk af lavere grad, der viser homozygot deletion af CDKN2A og/eller CDKN2B
- BEMÆRK: Berettigelseskriterierne blev ændret til at inkludere det nye diagnostiske sprog fra WHO 2021 patologiklassifikationsændringen. Ovenstående diagnoser afspejler derfor ændringen og inkluderer de enheder, der tidligere var kvalificerede, men som nu har opdateret patologisk klassifikation
- Tilstedeværelse af målbar sygdom, som defineret ved en bidimensionelt målbar læsion på magnetisk resonansbilleddannelse (MRI) med en minimumsdiameter på 10 mm i begge dimensioner, før resektion eller biopsi af tilbagevendende tumor
- Væv tilgængeligt fra kirurgisk resektion eller biopsi af recidiverende tumor =< 28 dage før præregistrering, eller planlagt operation eller biopsi af recidiverende tumor =< 28 dage efter præregistrering
- Kræver ikke > 4 mg dexamethason ud over den perioperative periode defineret som tiden =< 2 uger efter kirurgisk indgreb
Ingen aktiv autoimmun sygdom eller historie med autoimmun sygdom
- Disse omfatter, men er ikke begrænset til, patienter med en historie med immunrelateret neurologisk sygdom, multipel sklerose, autoimmun (demyeliniserende) neuropati, Guillain-Barre syndrom, myasthenia gravis; systemisk autoimmun sygdom, såsom systemisk lupus erythematosus (SLE), bindevævssygdomme, sklerodermi, inflammatorisk tarmsygdom (IBD), Crohns, ulcerøs colitis, hepatitis; og patienter med en historie med toksisk epidermal nekrolyse (TEN), Stevens-Johnsons syndrom eller fosfolipidsyndrom bør udelukkes på grund af risikoen for tilbagefald eller forværring af sygdommen
- Patienter med vitiligo, endokrine mangler inklusive thyroiditis behandlet med erstatningshormoner inklusive fysiologiske kortikosteroider er kvalificerede. Patienter med reumatoid arthritis og andre artropatier, Sjogrens syndrom og psoriasis kontrolleret med topisk medicin og patienter med positiv serologi, såsom antinukleære antistoffer (ANA), anti-thyroid antistoffer bør evalueres for tilstedeværelsen af målorganinvolvering og potentielt behov for systemisk behandling men skulle ellers være berettiget
- Ingen forudgående behandling med checkpoint-blokadebehandlinger (anti-CTLA4, anti-PD1/PD-L1) eller bevacizumab
- Ingen forudgående behandling med laserablation på tidspunktet for tilbagevendende tumorvævsprøvetagning. Patienter, som tidligere har gennemgået laserablation >= 4 måneder før tilbagevendende tumorvævsprøvetagning kan inkluderes
- Alder >= 18 år
- Eastern Cooperative Oncology Group (ECOG) præstationsstatus =< 2
- I stand til at gennemgå hjerne-MR med kontrast
- Absolut neutrofiltal >= 1500/mm^3
- Blodpladetal >= 100.000/mm^3
Total bilirubin =< 1,5 x øvre normalgrænse (ULN)
- Hvis Gilbert syndrom, så total bilirubin =< 3 x ULN
- Alaninaminotransferase (ALT) og aspartataminotransferase (AST) =< 2,0 x ULN
- Kreatinin =< 1,5 x ULN ELLER kreatininclearance (CrCl) >= 50 ml/min (hvis du bruger Cockcroft-Gault-formlen)
- Anamnese med aktiv malignitet (uden for patientens glioblastom), som har krævet behandling inden for de foregående 2 år. Deltagere med tidligere in situ-kræft eller basal- eller planocellulær hudkræft er berettiget
- REGISTRERINGSKRITERIER: Væv opnået fra biopsi eller resektion ved første eller anden recidiv udviser TMB >= 10 ved FoundationOne CDx-test
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Behandling (nivolumab, ipilimumab)
Patienterne får nivolumab IV over 30 minutter og ipilimumab IV over 30 minutter på dag 1.
Behandlingen gentages hver 3. uge i 4 cyklusser i fravær af sygdomsprogression eller uacceptabel toksicitet.
Patienterne får derefter nivolumab IV over 30 minutter på dag 1.
Cykler gentages hver 4. uge i fravær af sygdomsprogression eller uacceptabel toksicitet.
Patienterne gennemgår også MR under hele undersøgelsen.
|
Givet IV
Andre navne:
Gennemgå MR
Andre navne:
Givet IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet svarprocent
Tidsramme: Op til 32 måneder
|
Vurderet ved responsvurderingen i neuro-onkologikriterier (RANO).
Andelen af patienter, der har en bekræftet tumorrespons, beregnes som antallet af patienter med et bekræftet komplet respons eller bekræftet delvis respons som bestemt ved RANO -kriterier divideret med antallet af evaluerbare patienter, som er berettigede patienter, der har målbar sygdom og afsluttet en behandlingscyklus.
Vil blive estimeret med et binomial punktestimat, der beregnes som antallet af svar divideret med antallet af evaluerende patienter.
Eksakte 95% binomiale konfidensintervaller genereres og rapporteres.
|
Op til 32 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse (OS)
Tidsramme: Fra tidspunktet for behandlingens påbegyndelse til døden uanset årsag, vurderet op til 3 år
|
Vil blive opsummeret ved hjælp af Kaplan-Meier (KM) estimatorer.
Overlevelseskurver vil blive genereret fra KM-estimatorerne.
KM-estimater vil blive bestemt for median OS såvel som 12-måneders OS-rater.
Der vil blive angivet konfidensintervaller for medianværdierne såvel som de etårige rater.
|
Fra tidspunktet for behandlingens påbegyndelse til døden uanset årsag, vurderet op til 3 år
|
|
Progressionsfri overlevelse (PFS)
Tidsramme: Fra tidspunktet for behandlingsstart til sygdomsprogression målt ved hjælp af RANO-kriterier eller død, alt efter hvad der indtræffer først, vurderet op til 3 år
|
Vil blive opsummeret ved hjælp af KM-estimatorer.
Overlevelseskurver vil blive genereret fra KM-estimatorerne.
KM-estimater vil blive bestemt for median-PFS samt 12-måneders PFS-rater.
Der vil blive angivet konfidensintervaller for medianværdierne såvel som de etårige rater.
|
Fra tidspunktet for behandlingsstart til sygdomsprogression målt ved hjælp af RANO-kriterier eller død, alt efter hvad der indtræffer først, vurderet op til 3 år
|
|
Forekomst af bivirkninger (AE'er)
Tidsramme: Op til 3 år
|
AE'erne vil blive opsummeret med hyppigheden og den relative frekvens af den maksimale grad, som patienterne oplever for alle registrerede AE'er.
Bivirkningsdata vil blive opsummeret af hver observeret AE med antallet af patienter, der rapporterede AE, samt andelen af patienter med AE.
|
Op til 3 år
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gavin P Dunn, Alliance for Clinical Trials in Oncology
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Astrocytom
- Aminosyrer, peptider og proteiner
- Proteiner
- Undersøgelsesteknikker
- Biologiske faktorer
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Kemiteknikker, analytisk
- Spektrumanalyse
- Receptorer, celleoverflade
- Membranproteiner
- Antigener
- Antigener, overflade
- Biomarkører
- Receptorer, immunologisk
- Antigener, differentiering, T-lymfocyt
- Antigener, differentiering
- Immune kontrolpunktsproteiner
- Costimulerende og inhiberende T-celle-receptorer
- Nivolumab
- Ipilimumab
- Magnetisk resonansspektroskopi
- CTLA-4-antigen
Andre undersøgelses-id-numre
- NCI-2019-07242 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180821 (U.S. NIH-bevilling/kontrakt)
- A071702 (Anden identifikator: CTEP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Diffus Gliom
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UMC UtrechtPrincess Maxima Center for Pediatric OncologyIkke rekrutterer endnuDiffus Midline Glioma, H3 K27-ændretHolland
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Children's Oncology GroupRekrutteringAstrocytom i barndommen | Glioblastom i barndommen | Barndom diffus iboende pontin glioma | Barndom diffus midtlinie glioma | Barndom ondartet gliomForenede Stater
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Memorial Sloan Kettering Cancer CenterNovartis PharmaceuticalsRekrutteringGliom | Glioblastom, IDH-vildtype | Diffus Midline Glioma, H3 K27-ændret | Diffus astrocytom, IDH-vildtype (grad 2-4) | Diffus Hjerneskælvet Gliom, H3 G34-mutant | Diffus pædiatrisk højgradigt gliom, H3-wildtype og IDH-wildtypeForenede Stater
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University College, LondonRekrutteringDiffus Midline Glioma, H3 K27M-MutantDet Forenede Kongerige
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Mayo ClinicNational Cancer Institute (NCI)RekrutteringDiffus Midline Glioma, H3 K27M-MutantForenede Stater
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University of California, San FranciscoParker Institute for Cancer Immunotherapy; The V Foundation; Alliance for...Aktiv, ikke rekrutterendeDiffus Midline Glioma, H3 K27M-MutantForenede Stater
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Sabine Mueller, MD, PhDIkke rekrutterer endnuGlioblastom | Diffus Midline Glioma, H3 K27M-Mutant | Gliom af høj kvalitet | Gliom med høj kvalitet (WHO III-IV) | Diffus Hemisfærisk Gliom, H3G34-mutantForenede Stater
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Children's Hospital Medical Center, CincinnatiThe DIPG CollaborativeRekrutteringDiffus Intrinsic Pontine Gliom | Diffus Midline Glioma, H3 K27M-Mutant | Diffus midtlinjegliomForenede Stater
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Gustave Roussy, Cancer Campus, Grand ParisMinistry of Health, France; Jazz Pharmaceuticals; Innovative Therapies For...RekrutteringDiffus Intrinsic Pontine Gliom | Diffus Midline Glioma, H3 K27M-Mutant | Diffus midtlinjegliom, H3K27-ændretFrankrig, Sverige, Danmark, Spanien
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Petrov, AndreyLytvin,RuslanSuspenderetGlioblastoma Multiforme | Gliosarkom | GBM | Diffus Midline Glioma, H3 K27M-Mutant | KæmpecelleglioblastomGeorgien, Kasakhstan, Ukraine
Kliniske forsøg med Nivolumab
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Universitair Ziekenhuis BrusselRekruttering
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Brown UniversityBristol-Myers Squibb; The Miriam Hospital; Rhode Island Hospital; Women and...AfsluttetLivmoderhalskræftForenede Stater
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Baptist Health South FloridaBristol-Myers Squibb; NovoCure Ltd.AfsluttetTilbagevendende glioblastomForenede Stater
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Blokhin's Russian Cancer Research CenterTilmelding efter invitationMavekræft | Kolorektal cancerRusland
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Bristol-Myers SquibbAktiv, ikke rekrutterendeMelanomSpanien, Grækenland, Italien, Forenede Stater, Chile
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National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... og andre samarbejdspartnereAfsluttetHepatocellulært karcinom (HCC)Taiwan
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HUYABIO International, LLC.Bristol-Myers SquibbAktiv, ikke rekrutterendeUoperabelt eller metastatisk melanom | Progressiv hjernemetastaseNew Zealand, Spanien, Forenede Stater, Belgien, Frankrig, Tyskland, Singapore, Australien, Japan, Sydafrika, Italien, Brasilien, Tjekkiet, Østrig, Det Forenede Kongerige, Sydkorea, Puerto Rico
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Michael B. Atkins, MDBristol-Myers Squibb; Hoosier Cancer Research NetworkAfsluttetAvanceret nyrecellekarcinomForenede Stater
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National Research Center for Hematology, RussiaRekrutteringHodgkins sygdom | Hodgkin lymfom | Avanceret Hodgkin-lymfomRusland
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Jennifer ZhangAlligator Bioscience ABRekrutteringBrystkræftForenede Stater