- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03944941
Avelumab med eller uden cetuximab til behandling af patienter med avanceret pladecellekræft
Fase II randomiseret forsøg med Avelumab Plus Cetuximab versus Avelumab alene i avanceret kutan pladecellecarcinom i huden (cSCC)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMÆRE MÅL:
I. At evaluere om behandling med avelumab plus cetuximab forlænger progressionsfri overlevelse (PFS) sammenlignet med avelumab alene.
SEKUNDÆRE MÅL:
I. At evaluere den bekræftede objektive responsrate for hver behandlingsarm. II. At evaluere den kliniske fordelsrate for hver behandlingsarm. III. At evaluere PFS af cetuximab plus avelumab hos patienter, der har udviklet sig på enkeltmiddel avelumab.
IV. At evaluere den samlede overlevelse (OS) for hver behandlingsarm. V. At evaluere toksicitet på tværs af behandlingsarme af avelumab plus cetuximab og avelumab alene.
OVERSIGT: Patienterne randomiseres til 1 af 2 arme.
ARM I: Patienter får avelumab intravenøst (IV) over 60 minutter på dag 1 og 15. Behandlingen gentages hver 28. dag i op til 24 cyklusser i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienter med avelumabsvigt vil gå over til arm II.
ARM II: Patienter får cetuximab IV over 1-2 timer på dag 1, 8, 15 og 22 og avelumab IV over 60 minutter på dag 1 og 15. Behandlingen gentages hver 28. dag i op til 12 cyklusser for cetuximab og 24 cyklusser for avelumab i fravær af sygdomsprogression eller uacceptabel toksicitet.
Efter afslutning af undersøgelsesbehandlingen følges patienterne op hver 3. måned indtil sygdomsprogression, derefter hver 6. måned i op til 2 år.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham Cancer Center
-
-
Alaska
-
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
-
Anchorage, Alaska, Forenede Stater, 99504
- Anchorage Radiation Therapy Center
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Fairbanks, Alaska, Forenede Stater, 99701
- Fairbanks Memorial Hospital
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Arizona
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Kingman, Arizona, Forenede Stater, 86401
- Kingman Regional Medical Center
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Tucson, Arizona, Forenede Stater, 85704
- University of Arizona Cancer Center-Orange Grove Campus
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Tucson, Arizona, Forenede Stater, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, Forenede Stater, 85719
- University of Arizona Cancer Center-North Campus
-
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Arkansas
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Fort Smith, Arkansas, Forenede Stater, 72903
- Mercy Hospital Fort Smith
-
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California
-
Arroyo Grande, California, Forenede Stater, 93420
- PCR Oncology
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Dublin, California, Forenede Stater, 94568
- Epic Care-Dublin
-
Emeryville, California, Forenede Stater, 94608
- Bay Area Breast Surgeons Inc
-
Emeryville, California, Forenede Stater, 94608
- Epic Care Partners in Cancer Care
-
Los Angeles, California, Forenede Stater, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, Forenede Stater, 90033
- Los Angeles General Medical Center
-
Martinez, California, Forenede Stater, 94553-3156
- Contra Costa Regional Medical Center
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Newport Beach, California, Forenede Stater, 92663
- USC Norris Oncology/Hematology-Newport Beach
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Oakland, California, Forenede Stater, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Forenede Stater, 94609
- Bay Area Tumor Institute
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Pasadena, California, Forenede Stater, 91105
- Keck Medical Center of USC Pasadena
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Walnut Creek, California, Forenede Stater, 94597
- Epic Care Cyberknife Center
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Forenede Stater, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Forenede Stater, 80303
- Boulder Community Foothills Hospital
-
Boulder, Colorado, Forenede Stater, 80304
- Rocky Mountain Cancer Centers-Boulder
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Centennial, Colorado, Forenede Stater, 80112
- Rocky Mountain Cancer Centers - Centennial
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, Forenede Stater, 80220
- Rose Medical Center
-
Denver, Colorado, Forenede Stater, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, Forenede Stater, 80220
- Rocky Mountain Cancer Centers-Rose
-
Denver, Colorado, Forenede Stater, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, Forenede Stater, 80209
- The Women's Imaging Center
-
Denver, Colorado, Forenede Stater, 80220
- Western Surgical Care
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Englewood, Colorado, Forenede Stater, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, Forenede Stater, 80113
- Swedish Medical Center
-
Englewood, Colorado, Forenede Stater, 80113
- Rocky Mountain Cancer Centers - Swedish
-
Englewood, Colorado, Forenede Stater, 80113
- The Melanoma and Skin Cancer Institute
-
Greeley, Colorado, Forenede Stater, 80631
- North Colorado Medical Center
-
Lakewood, Colorado, Forenede Stater, 80228
- Rocky Mountain Cancer Centers-Lakewood
-
Littleton, Colorado, Forenede Stater, 80120
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, Forenede Stater, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Loveland, Colorado, Forenede Stater, 80539
- McKee Medical Center
-
Thornton, Colorado, Forenede Stater, 80260
- Rocky Mountain Cancer Centers-Thornton
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital/Winship Cancer Institute
-
Savannah, Georgia, Forenede Stater, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
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, 83686
- Saint Luke's Cancer Institute - Nampa
-
Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, Forenede Stater, 83864
- Kootenai Cancer Clinic
-
Twin Falls, Idaho, Forenede Stater, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Alton, Illinois, Forenede Stater, 62002
- Saint Anthony's Health
-
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, 60611
- Northwestern University
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Comprehensive Cancer Center
-
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
-
Galesburg, Illinois, Forenede Stater, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
-
Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
-
Lake Forest, Illinois, Forenede Stater, 60045
- Northwestern Medicine Lake Forest Hospital
-
Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, Forenede Stater, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, Forenede Stater, 62864
- Good Samaritan Regional Health Center
-
New Lenox, Illinois, Forenede Stater, 60451
- UC Comprehensive Cancer Center at Silver Cross
-
O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
-
Orland Park, Illinois, Forenede Stater, 60462
- University of Chicago Medicine-Orland Park
-
Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
-
Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
-
Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Forenede Stater, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, Forenede Stater, 62781
- Memorial Medical Center
-
Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
-
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
-
Richmond, Indiana, Forenede Stater, 47374
- Reid Health
-
-
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
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Heartland Oncology and Hematology LLP
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Methodist Jennie Edmundson Hospital
-
Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, Forenede Stater, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, Forenede Stater, 50316
- Iowa Lutheran Hospital
-
Fort Dodge, Iowa, Forenede Stater, 50501
- Trinity Regional Medical Center
-
Fort Dodge, Iowa, Forenede Stater, 50501
- McFarland Clinic - Trinity Cancer Center
-
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
-
-
Kansas
-
Garden City, Kansas, Forenede Stater, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, Forenede Stater, 67530
- Central Care Cancer Center - Great Bend
-
-
Louisiana
-
Kenner, Louisiana, Forenede Stater, 70065
- Ochsner Medical Center Kenner
-
New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center Jefferson
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Comprehensive Cancer Center
-
Battle Creek, Michigan, Forenede Stater, 49017
- Bronson Battle Creek
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health at Butterworth Campus
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Helen DeVos Children's Hospital at Spectrum Health
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Trinity Health Grand Rapids Hospital
-
Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Forenede Stater, 49048
- Borgess Medical Center
-
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
-
Port Huron, Michigan, Forenede Stater, 48060
- Lake Huron Medical Center
-
Port Huron, Michigan, Forenede Stater, 48060
- Huron Medical Center PC
-
Reed City, Michigan, Forenede Stater, 49677
- Corewell Health Reed City Hospital
-
Saint Joseph, Michigan, Forenede Stater, 49085
- Lakeland Medical Center Saint Joseph
-
Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
-
Wyoming, Michigan, Forenede Stater, 49519
- University of Michigan Health - West
-
-
Minnesota
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Aitkin, Minnesota, Forenede Stater, 56431
- Riverwood Healthcare 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
-
Detroit Lakes, Minnesota, Forenede Stater, 56501
- Essentia Health Saint Mary's - Detroit Lakes Clinic
-
Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Cancer Center
-
Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Saint Mary's Medical Center
-
Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Hospital
-
Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Forenede Stater, 56537
- Lake Region Healthcare Corporation-Cancer Care
-
Fosston, Minnesota, Forenede Stater, 56542
- Essentia Health - Fosston
-
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
-
Park Rapids, Minnesota, Forenede Stater, 56470
- Essentia Health - Park Rapids
-
Princeton, Minnesota, Forenede Stater, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, Forenede Stater, 55422
- North Memorial Medical Health Center
-
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
-
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
-
Wyoming, Minnesota, Forenede Stater, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Ballwin, Missouri, Forenede Stater, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
-
Bolivar, Missouri, Forenede Stater, 65613
- Central Care Cancer Center - Bolivar
-
Branson, Missouri, Forenede Stater, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Forenede Stater, 63703
- Southeast Cancer Center
-
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
- Capital Region Southwest Campus
-
Joplin, Missouri, Forenede Stater, 64804
- Freeman Health System
-
Joplin, Missouri, Forenede Stater, 64804
- Mercy Hospital Joplin
-
Rolla, Missouri, Forenede Stater, 65401
- Delbert Day Cancer Institute at PCRMC
-
Rolla, Missouri, Forenede Stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
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, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
-
St Louis, Missouri, Forenede Stater, 63109
- Saint Louis Cancer and Breast Institute-South City
-
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 Deaconess Hospital
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
- Benefis Healthcare- Sletten Cancer Institute
-
Helena, Montana, Forenede Stater, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
-
Missoula, Montana, Forenede Stater, 59804
- Community Medical Hospital
-
Missoula, Montana, Forenede Stater, 59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Hospital
-
-
Nevada
-
Carson City, Nevada, Forenede Stater, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Forenede Stater, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Forenede Stater, 89052
- OptumCare Cancer Care at Seven Hills
-
Henderson, Nevada, Forenede Stater, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Forenede Stater, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Forenede Stater, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Forenede Stater, 89074
- GenesisCare USA - Henderson
-
Henderson, Nevada, Forenede Stater, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Forenede Stater, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Forenede Stater, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Forenede Stater, 89074
- Urology Specialists of Nevada - Green Valley
-
Las Vegas, Nevada, Forenede Stater, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Forenede Stater, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Forenede Stater, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Forenede Stater, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Forenede Stater, 89109
- GenesisCare USA - Las Vegas
-
Las Vegas, Nevada, Forenede Stater, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Forenede Stater, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Forenede Stater, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Forenede Stater, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Forenede Stater, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Forenede Stater, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Forenede Stater, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89148
- OptumCare Cancer Care at Fort Apache
-
Las Vegas, Nevada, Forenede Stater, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Forenede Stater, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Forenede Stater, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Forenede Stater, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Forenede Stater, 89128
- GenesisCare USA - Vegas Tenaya
-
Las Vegas, Nevada, Forenede Stater, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Forenede Stater, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Forenede Stater, 89148
- GenesisCare USA - Fort Apache
-
Las Vegas, Nevada, Forenede Stater, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Forenede Stater, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Forenede Stater, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Forenede Stater, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Forenede Stater, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Forenede Stater, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Forenede Stater, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Forenede Stater, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Forenede Stater, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Forenede Stater, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Forenede Stater, 89169
- University Cancer Center
-
Las Vegas, Nevada, Forenede Stater, 89113
- Urology Specialists of Nevada - Southwest
-
Pahrump, Nevada, Forenede Stater, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Forenede Stater, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Forenede Stater, 89509
- Radiation Oncology Associates
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87102
- University of New Mexico Cancer Center
-
-
New York
-
New York, New York, Forenede Stater, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
-
North Carolina
-
Clinton, North Carolina, Forenede Stater, 28328
- Southeastern Medical Oncology Center-Clinton
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Jacksonville, North Carolina, Forenede Stater, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
-
North Dakota
-
Fargo, North Dakota, Forenede Stater, 58103
- Essentia Health Cancer Center-South University Clinic
-
Jamestown, North Dakota, Forenede Stater, 58401
- Essentia Health - Jamestown Clinic
-
-
Ohio
-
Beavercreek, Ohio, Forenede Stater, 45431
- Indu and Raj Soin Medical Center
-
Belpre, Ohio, Forenede Stater, 45714
- Strecker Cancer Center-Belpre
-
Boardman, Ohio, Forenede Stater, 44512
- Saint Elizabeth Boardman Hospital
-
Centerville, Ohio, Forenede Stater, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Forenede Stater, 45459
- Dayton Physicians LLC-Miami Valley South
-
Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45236
- Oncology Hematology Care Inc-Kenwood
-
Columbus, Ohio, Forenede Stater, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Forenede Stater, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Forenede Stater, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, Forenede Stater, 43228
- Doctors Hospital
-
Columbus, Ohio, Forenede Stater, 43213
- Mount Carmel East Hospital
-
Columbus, Ohio, Forenede Stater, 43215
- Grant Medical Center
-
Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health Center West
-
Dayton, Ohio, Forenede Stater, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Dayton Physician LLC-Miami Valley Hospital North
-
Dayton, Ohio, Forenede Stater, 45415
- Miami Valley Hospital North
-
Delaware, Ohio, Forenede Stater, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
-
Dublin, Ohio, Forenede Stater, 43016
- Dublin Methodist Hospital
-
Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Forenede Stater, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Forenede Stater, 45840
- Orion Cancer Care
-
Franklin, Ohio, Forenede Stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Forenede Stater, 45005
- Dayton Physicians LLC-Atrium
-
Gahanna, Ohio, Forenede Stater, 43230
- Central Ohio Breast and Endocrine Surgery
-
Greenville, Ohio, Forenede Stater, 45331
- Wayne Hospital
-
Greenville, Ohio, Forenede Stater, 45331
- Dayton Physicians LLC-Wayne
-
Grove City, Ohio, Forenede Stater, 43123
- Mount Carmel Grove City Hospital
-
Kettering, Ohio, Forenede Stater, 45429
- Kettering Medical Center
-
Kettering, Ohio, Forenede Stater, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Forenede Stater, 45420
- First Dayton Cancer Care
-
Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
-
Lima, Ohio, Forenede Stater, 45801
- Saint Rita's Medical Center
-
Mansfield, Ohio, Forenede Stater, 44903
- OhioHealth Mansfield Hospital
-
Marietta, Ohio, Forenede Stater, 45750
- Marietta Memorial Hospital
-
Marion, Ohio, Forenede Stater, 43302
- OhioHealth Marion General Hospital
-
Mount Vernon, Ohio, Forenede Stater, 43050
- Knox Community Hospital
-
Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Hospital
-
Newark, Ohio, Forenede Stater, 43055
- Newark Radiation Oncology
-
Perrysburg, Ohio, Forenede Stater, 43551
- Mercy Health Perrysburg Cancer Center
-
Portsmouth, Ohio, Forenede Stater, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, Forenede Stater, 45505
- Springfield Regional Medical Center
-
Springfield, Ohio, Forenede Stater, 45504
- Springfield Regional Cancer Center
-
Steubenville, Ohio, Forenede Stater, 43952
- Trinity's Tony Teramana Cancer Center
-
Toledo, Ohio, Forenede Stater, 43608
- Saint Vincent Mercy Medical Center
-
Toledo, Ohio, Forenede Stater, 43623
- Mercy Health - Saint Anne Hospital
-
Troy, Ohio, Forenede Stater, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Forenede Stater, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Forenede Stater, 44484
- Saint Joseph Warren Hospital
-
Westerville, Ohio, Forenede Stater, 43081
- Saint Ann's Hospital
-
Youngstown, Ohio, Forenede Stater, 44501
- Saint Elizabeth Youngstown Hospital
-
Zanesville, Ohio, Forenede Stater, 43701
- Genesis Healthcare System Cancer Care Center
-
-
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 Medical 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 Medical 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
-
Altoona, Pennsylvania, Forenede Stater, 16601
- UPMC Altoona
-
Beaver, Pennsylvania, Forenede Stater, 15009
- UPMC-Heritage Valley Health System Beaver
-
Bethel Park, Pennsylvania, Forenede Stater, 15102
- UPMC Cancer Center-Bethel Park
-
Butler, Pennsylvania, Forenede Stater, 16001
- UPMC Hillman Cancer Center at Butler Health System
-
Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
-
Erie, Pennsylvania, Forenede Stater, 16505
- UPMC Hillman Cancer Center Erie
-
Erie, Pennsylvania, Forenede Stater, 16550
- UPMC Hamot
-
Farrell, Pennsylvania, Forenede Stater, 16121
- UPMC Cancer Center at UPMC Horizon
-
Greensburg, Pennsylvania, Forenede Stater, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
-
Greenville, Pennsylvania, Forenede Stater, 16125
- Oncology Hematology Associates
-
Harrisburg, Pennsylvania, Forenede Stater, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Harrisburg, Pennsylvania, Forenede Stater, 17101
- UPMC Pinnacle Harrisburg
-
Hazleton, Pennsylvania, Forenede Stater, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Indiana, Pennsylvania, Forenede Stater, 15701
- IRMC Cancer Center
-
Johnstown, Pennsylvania, Forenede Stater, 15901
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
-
Lewisburg, Pennsylvania, Forenede Stater, 17837
- Geisinger Medical Oncology-Lewisburg
-
Lewistown, Pennsylvania, Forenede Stater, 17044
- Lewistown Hospital
-
McKeesport, Pennsylvania, Forenede Stater, 15132
- UPMC Cancer Center at UPMC McKeesport
-
Mechanicsburg, Pennsylvania, Forenede Stater, 17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
-
Monroeville, Pennsylvania, Forenede Stater, 15146
- UPMC Hillman Cancer Center - Monroeville
-
Monroeville, Pennsylvania, Forenede Stater, 15146
- UPMC Cancer Center - Monroeville
-
Moon Township, Pennsylvania, Forenede Stater, 15108
- UPMC Hillman Cancer Center in Coraopolis
-
Mount Pleasant, Pennsylvania, Forenede Stater, 15666
- UPMC Hillman Cancer Center - Part of Frick Hospital
-
New Castle, Pennsylvania, Forenede Stater, 16105
- UPMC Hillman Cancer Center - New Castle
-
North Huntingdon, Pennsylvania, Forenede Stater, 15642
- Arnold Palmer Cancer Center Medical Oncology Norwin
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC-Shadyside Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15215
- UPMC-Saint Margaret
-
Pittsburgh, Pennsylvania, Forenede Stater, 15237
- UPMC-Passavant Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15243
- UPMC-Saint Clair Hospital Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15215
- Oncology Hematology Association
-
Pottsville, Pennsylvania, Forenede Stater, 17901
- Geisinger Cancer Services-Pottsville
-
Scranton, Pennsylvania, Forenede Stater, 18510
- Community Medical Center
-
Selinsgrove, Pennsylvania, Forenede Stater, 17870
- Geisinger Medical Oncology-Selinsgrove
-
Seneca, Pennsylvania, Forenede Stater, 16346
- UPMC Cancer Center at UPMC Northwest
-
State College, Pennsylvania, Forenede Stater, 16801
- Geisinger Medical Group
-
Uniontown, Pennsylvania, Forenede Stater, 15401
- UPMC Cancer Center-Uniontown
-
Washington, Pennsylvania, Forenede Stater, 15301
- UPMC Cancer Center-Washington
-
West Mifflin, Pennsylvania, Forenede Stater, 15122
- UPMC West Mifflin-Cancer Center Jefferson
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Williamsport, Pennsylvania, Forenede Stater, 17701
- UPMC Susquehanna
-
Williamsport, Pennsylvania, Forenede Stater, 17754
- Divine Providence Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37920
- University of Tennessee - Knoxville
-
-
Virginia
-
Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
-
Washington
-
Aberdeen, Washington, Forenede Stater, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, Forenede Stater, 98004
- Overlake Medical Center
-
Bellingham, Washington, Forenede Stater, 98225
- PeaceHealth Saint Joseph Medical Center
-
Centralia, Washington, Forenede Stater, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Forenede Stater, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, Forenede Stater, 98201
- Providence Regional Cancer Partnership
-
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
-
Longview, Washington, Forenede Stater, 98632
- PeaceHealth Saint John Medical Center
-
Port Townsend, Washington, Forenede Stater, 98368
- Jefferson Healthcare
-
Renton, Washington, Forenede Stater, 98055
- Valley Medical Center
-
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
-
Vancouver, Washington, Forenede Stater, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Forenede Stater, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Forenede Stater, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, Forenede Stater, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Ashland, Wisconsin, Forenede Stater, 54806
- Duluth Clinic Ashland
-
Ashland, Wisconsin, Forenede Stater, 54806
- Northwest Wisconsin Cancer Center
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Medical Center-EC Cancer Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Forenede Stater, 54548
- Marshfield Clinic-Minocqua Center
-
New Richmond, Wisconsin, Forenede Stater, 54017
- Cancer Center of Western Wisconsin
-
Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Medical Center-Rice Lake
-
Stevens Point, Wisconsin, Forenede Stater, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Medical Center - Weston
-
-
Wyoming
-
Cheyenne, Wyoming, Forenede Stater, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, Forenede Stater, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- KRITERIER FOR BERETNING TIL FORHÅNDT REGISTRERING
Sørg for tilstrækkeligt væv til PD-L1-testning
* Frisk væv eller arkivvæv kan bruges. Prøven skal mindst være kernenålebiopsi. Finnålsaspiration er ikke tilstrækkelig. Denne prøveindsendelse er obligatorisk før registrering, da resultaterne vil blive brugt til stratificering
- KRITERIER FOR BERETNING TIL REGISTRERING
- • Biopsi-bevist avanceret kutant pladecellecarcinom. Avanceret sygdom defineres som enten metastatisk kutant planocellulært karcinom eller lokalt fremskredent kutant planocellulært karcinom, der ikke er modtageligt for kurativ kirurgisk resektion, eller patienten afslår kirurgisk resektion
- Patienten skal have mindst én læsion, der er målbar sygdom baseret på responsevalueringskriterier i solide tumorer (RECIST) 1.1
- Hvis patienten har gennemgået en større operation, skal de have restitueret sig tilstrækkeligt efter toksiciteten og/eller komplikationerne fra interventionen før behandlingen påbegyndes
- Denne undersøgelse involverer et forsøgsmiddel, hvis genotoksiske, mutagene og teratogene virkninger på det udviklende foster og nyfødte er ukendte. Kun for kvinder i den fødedygtige alder kræves derfor en negativ urin- eller serumgraviditetstest udført =< 7 dage før registrering.
- Eastern Cooperative Oncology Group (ECOG) præstationsstatus 0-2
- Hvis human immundefektvirus (HIV) er positiv, skal HIV-virusmængden være < 200 kopier/ml og CD4-tal > 200. Hvis en hiv-positiv patient er i højaktiv antiretroviral behandling (HAART), skal patienten have været det i > 4 uger
- Absolut neutrofiltal (ANC) >= 1.500/mm^3
- Blodpladetal >= 100.000/mm^3
- Beregnet kreatininclearance >= 30 ml/min
- Total bilirubin =< 1,5 x øvre normalgrænse (ULN)
- Aspartataminotransferaser (AST) / alaninaminotransferase (ALT) =< 2,5 x øvre normalgrænse (ULN)
Ekskluderingskriterier:
- Patienter, der tidligere har modtaget behandling med cetuximab som palliativ behandling for fremskreden kutant pladecellekarcinom (cSCC), er udelukket. Patienter, der modtog cetuximab-baseret kemoradiation (enten definitiv eller adjuverende) som tidligere behandling for lokalt fremskreden sygdom, er kvalificerede, så længe den sidste dosis blev givet >= 6 måneder før registrering
- Patienter, der tidligere har fået cetuximab og havde en alvorlig infusionsreaktion, der krævede seponering af cetuximab, er udelukket
- Patienter behandlet med tidligere anti-PD-1 eller anti-PD-L1 monoklonale antistoffer (mAbs) er udelukket
- Patienter kan ikke have modtaget behandling med strålebehandling eller kemoterapi inklusive et andet forsøgsmiddel inden for 2 uger efter registrering. Bortset fra som angivet ovenfor for cetuximab er der ingen grænser for antallet af linjer af andre behandlinger givet til avanceret cSCC
- Patienter med en "aktuelt aktiv" anden malignitet vil blive udelukket med undtagelse af andre ikke-melanom hudkræftformer eller cervikal carcinom in situ. Patienter anses ikke for at have en "aktuelt aktiv" malignitet, hvis de har afsluttet behandlingen og er fri for sygdom i 3 år
Ingen historie om følgende:
- Autoimmun sygdom (herunder inflammatorisk tarmsygdom) med undtagelse af patienter med diabetes type I, vitiligo, psoriasis eller hypo- eller hyperthyreoideasygdomme, der ikke kræver immunsuppressiv behandling
- Ikke-infektiøs pneumonitis, der krævede steroider inden for 5 år
- Organtransplantation inklusive tidligere stamcelletransplantation
- Modtagelse af levende vaccine =< 4 uger
- Cerebral vaskulær ulykke/slagtilfælde inden for 6 måneder efter tilmelding
- Myokardieinfarkt inden for 6 måneder efter tilmelding
- Aktiv ustabil angina
- Kongestiv hjertesvigt (>= New York Heart Association Classification class II)
- Alvorlig hjertearytmi, der kræver medicin. Hvorvidt en arytmi betragtes som "alvorlig" er op til efterforskerens skøn
- Aktiv infektion, der kræver systemisk behandling
Brug af immunsuppressiv medicin =< 7 dage efter registrering, UNDTAGET følgende:
- Intranasale, inhalerede, topiske steroider eller lokal steroidinjektion (f.eks. intraartikulær injektion)
- Systemiske kortikosteroider i fysiologiske doser =< 10 mg/dag af prednison eller tilsvarende
- Steroider som præmedicinering til overfølsomhedsreaktioner (f.eks. computertomografi [CT] scanning præmedicinering)"
- Andre alvorlige akutte eller kroniske medicinske tilstande, herunder, men ikke begrænset til, immun colitis, lungefibrose eller psykiatriske tilstande, herunder nylige (inden for det seneste år) eller aktive selvmordstanker eller -adfærd; eller laboratorieabnormiteter, der kan øge risikoen forbundet med undersøgelsesdeltagelse eller administration af undersøgelsesbehandling eller kan interferere med fortolkningen af undersøgelsesresultater og, efter investigators vurdering, ville gøre patienten uegnet til at deltage i denne undersøgelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I (Avelumab)
Patienter får avelumab IV over 60 minutter på dag 1 og 15.
Behandlingen gentages hver 28. dag i op til 24 cyklusser i fravær af sygdomsprogression eller uacceptabel toksicitet.
Patienter med avelumabsvigt vil gå over til arm II.
|
Givet IV
|
|
Eksperimentel: Arm II (Avelumab, cetuximab)
Patienterne får cetuximab IV over 1-2 timer på dag 1, 8, 15 og 22 og avelumab IV over 60 minutter på dag 1 og 15.
Behandlingen gentages hver 28. dag i op til 12 cyklusser for cetuximab og 24 cyklusser for avelumab i fravær af sygdomsprogression eller uacceptabel toksicitet.
|
Givet IV
Givet IV
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prolonging of Progression Free Survival (PFS) on Avelumab and Cetuximab Compared to Avelumab Alone
Tidsramme: Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 years
|
The study will be declared promising if, after the 37th PFS event, the hazard ratio is less than 0.758.
|
Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Confirmed Objective Response Rate (RR)
Tidsramme: Up to 2 years post treatment, up to 4 years
|
A patient will be declared a success for RR if they achieve a partial response (PR) or better on two consecutive evaluations (at least 8 weeks apart).
The number of successes will be divided by the number of evaluable patients to estimate the RR for each treatment arm and exact 95% confidence intervals will be calculated based on the properties of the binomial distribution.
|
Up to 2 years post treatment, up to 4 years
|
|
Clinical Benefit Rate (CBR)
Tidsramme: Up to 2 years post treatment, up to 4 years
|
The CBR will be estimated as the number of successes divided by the total number of evaluable patients.
An exact 95% confidence interval will be constructed around the CBR using the properties of the binomial distribution.
|
Up to 2 years post treatment, up to 4 years
|
|
PFS in Patients Who Have Progressed on Avelumab Alone
Tidsramme: Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 years
|
Will explore the PFS for those patients that crossover to combination therapy (avelumab + cetuximab) after progressing on avelumab alone (baseline time being the time of crossover).
The Kaplan-Meier method will be used to calculate a median PFS as well as a 95% confidence interval.
|
Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment, up to 4 years
|
|
Overall Survival (OS)
Tidsramme: Time between enrollment and or death, assessed up to 2 years post treatment, up to 4 years
|
The Kaplan-Meier method will be used to calculate a median OS as well as a 95% confidence interval.
|
Time between enrollment and or death, assessed up to 2 years post treatment, up to 4 years
|
|
Incidence of Grade 3+ Adverse Events
Tidsramme: Up to 30 days post treatment, up to 4 years
|
Will be described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Maximum grade adverse events will be summarized in a tabular setting by treatment arm.
|
Up to 30 days post treatment, up to 4 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Dan P. Zandberg, MD, University of Pittsburgh Medical Center Hillman Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
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 efter sted
- Neoplasmer
- Hudsygdomme
- Hud- og bindevævssygdomme
- Neoplasmer i huden
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Cetuximab
- avelumab
Andre undersøgelses-id-numre
- A091802
- U10CA180821 (U.S. NIH-bevilling/kontrakt)
- NCI-2018-02652 (Registry Identifier: NCI Clinical Trial Reporting Program)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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 Planocellulært hudkræft
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Mayo ClinicRekrutteringResecerbart hoved- og halspladecellekarcinom | HPV-negativt planocellulært karcinom | Resecerbart hoved- og nakkepladecellekarcinom | Human papillomavirus-negativ nakkepladecellekarcinom | Resektabel human papillomavirus-uafhængig hoved- og halsslimhinde Squamous Cell CarcinomaForenede Stater
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Prof. Dr. Remi A. NoutMerck Sharp & Dohme LLCIkke rekrutterer endnuLivmoderhalskræft af FIGO Stage 2018 | Pladecellecarcinom FIGO 2018 Stadium IIIA, IIIB, IIIC1-IIIC2 | Adenocarcinoma eller Adeno-squamous Carcinoma Stadium IB3-IIIC2Holland
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...Aktiv, ikke rekrutterendeUrothelialt karcinomJapan
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