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Nivolumab och Ipilimumab vid behandling av patienter med esofageal och gastroesofageal Junction Adenocarcinoma som genomgår operation

11 november 2026 uppdaterad av: National Cancer Institute (NCI)

En fas II/III-studie av perioperativt nivolumab och ipilimumab hos patienter med lokalt esofagus- och gastroesofagealt adenokarcinom

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

Studieöversikt

Status

Upphängd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. To assess the pathologic complete response (pathCR) rate following administration of neoadjuvant carboplatin, paclitaxel and radiation therapy versus neoadjuvant carboplatin, paclitaxel, radiation therapy and nivolumab in patients with a resected locoregionally advanced esophageal or gastroesophageal junction adenocarcinoma.

II. To assess the disease-free survival (DFS) following administration of adjuvant nivolumab and ipilimumab versus adjuvant nivolumab in patients with a resected locoregionally advanced esophageal or gastroesophageal junction adenocarcinoma who received neoadjuvant treatment with carboplatin, paclitaxel and radiation therapy with or without nivolumab.

SECONDARY OBJECTIVES:

I. To assess the overall survival (OS) following administration of adjuvant nivolumab and ipilimumab versus nivolumab in patients with a resected locoregional esophageal or gastroesophageal junctional adenocarcinoma who received neoadjuvant treatment with carboplatin, paclitaxel and radiation therapy with or without nivolumab.

II. To assess the disease free survival (DFS) following administration of neoadjuvant carboplatin, paclitaxel, and radiation therapy with or without nivolumab in patients with a locoregional esophageal or gastroesophageal junction adenocarcinoma.

III. To assess the toxicity associated with the administration of neoadjuvant nivolumab in combination with carboplatin, paclitaxel and radiation therapy in patients with a locoregional esophageal or gastroesophageal junction adenocarcinoma.

IV. To assess the toxicity associated with the administration of adjuvant nivolumab and ipilimumab versus adjuvant nivolumab in patients with a resected locoregional esophageal or gastroesophageal junction adenocarcinoma who received neoadjuvant treatment with carboplatin, paclitaxel and radiation therapy with or without nivolumab.

OUTLINE:

STEP I: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive carboplatin intravenously (IV) and paclitaxel IV once weekly and undergo radiation therapy once daily (QD) (Monday-Friday) beginning on day 1 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a computed tomography (CT) or positron emission tomography (PET) scan during screening and follow-up and undergo collection of blood samples throughout the trial.

ARM B: Patients receive carboplatin, paclitaxel, and radiation therapy as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.

STEP II: Patients are randomized to 1 of 2 arms following standard of care surgery.

ARM C: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.

ARM D: Patients receive nivolumab as in Arm C and receive ipilimumab IV over 90 minutes on day 1 of cycles 1 and 4 and day 15 of cycles 2 and 5. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for up to 5 years.

Studietyp

Interventionell

Inskrivning (Beräknad)

278

Fas

Fas 2
Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- Alaska
  - Anchorage, Alaska, Förenta staterna, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, Förenta staterna, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, Förenta staterna, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, Förenta staterna, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, Förenta staterna, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, Förenta staterna, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, Förenta staterna, 99508
    - Providence Alaska Medical Center
- Arizona
  - Phoenix, Arizona, Förenta staterna, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Fort Smith, Arkansas, Förenta staterna, 72903
    - Mercy Hospital Fort Smith
  - Hot Springs, Arkansas, Förenta staterna, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
  - Jonesboro, Arkansas, Förenta staterna, 72401
    - NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- California
  - Arroyo Grande, California, Förenta staterna, 93420
    - PCR Oncology
  - Burbank, California, Förenta staterna, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Clovis, California, Förenta staterna, 93611
    - Community Cancer Institute
  - Clovis, California, Förenta staterna, 93611
    - University Oncology Associates
  - Los Angeles, California, Förenta staterna, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, Förenta staterna, 90033
    - Los Angeles General Medical Center
  - Palo Alto, California, Förenta staterna, 94304
    - VA Palo Alto Health Care System
  - Palo Alto, California, Förenta staterna, 94304
    - Stanford Cancer Institute Palo Alto
  - Sacramento, California, Förenta staterna, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, Förenta staterna, 95816
    - Mercy Cancer Center - Sacramento
  - San Luis Obispo, California, Förenta staterna, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - Santa Maria, California, Förenta staterna, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - St. Helena, California, Förenta staterna, 94574
    - Saint Helena Hospital
  - Whittier, California, Förenta staterna, 90602
    - Presbyterian Intercommunity Hospital
  - Woodland, California, Förenta staterna, 95695
    - Woodland Memorial Hospital
- Colorado
  - Colorado Springs, Colorado, Förenta staterna, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, Förenta staterna, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Colorado Springs, Colorado, Förenta staterna, 80923
    - Saint Francis Cancer Center
  - Denver, Colorado, Förenta staterna, 80210
    - AdventHealth Porter
  - Lakewood, Colorado, Förenta staterna, 80228
    - CommonSpirit Saint Anthony Hospital Cancer Center
  - Littleton, Colorado, Förenta staterna, 80122
    - AdventHealth Littleton
  - Longmont, Colorado, Förenta staterna, 80501
    - Longmont United Hospital
  - Parker, Colorado, Förenta staterna, 80138
    - AdventHealth Parker
  - Pueblo, Colorado, Förenta staterna, 81004
    - Saint Mary Corwin Medical Center
- Delaware
  - Lewes, Delaware, Förenta staterna, 19958
    - Beebe Medical Center
  - Millville, Delaware, Förenta staterna, 19967
    - Beebe South Coastal Health Campus
  - Newark, Delaware, Förenta staterna, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, Förenta staterna, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, Förenta staterna, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, Förenta staterna, 19718
    - Christiana Care Health System-Christiana Hospital
  - Rehoboth Beach, Delaware, Förenta staterna, 19971
    - Beebe Health Campus
  - Seaford, Delaware, Förenta staterna, 19973
    - TidalHealth Nanticoke / Allen Cancer Center
- District of Columbia
  - Washington D.C., District of Columbia, Förenta staterna, 20007
    - MedStar Georgetown University Hospital
- Florida
  - Altamonte Springs, Florida, Förenta staterna, 32701
    - AdventHealth Altamonte
  - Aventura, Florida, Förenta staterna, 33180
    - Mount Sinai Comprehensive Cancer Center at Aventura
  - Fort Lauderdale, Florida, Förenta staterna, 33308
    - Holy Cross Hospital
  - Fort Myers, Florida, Förenta staterna, 33905
    - Regional Cancer Center-Lee Memorial Health System
  - Gainesville, Florida, Förenta staterna, 32610
    - UF Health Cancer Institute - Gainesville
  - Kissimmee, Florida, Förenta staterna, 34744
    - AdventHealth Kissimmee
  - Miami Beach, Florida, Förenta staterna, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, Förenta staterna, 32803
    - AdventHealth Orlando
  - Orlando, Florida, Förenta staterna, 32822
    - AdventHealth East Orlando
- Georgia
  - Atlanta, Georgia, Förenta staterna, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, Förenta staterna, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, Förenta staterna, 30342
    - Emory Saint Joseph's Hospital
  - Atlanta, Georgia, Förenta staterna, 30308
    - Emory Proton Therapy Center
  - Savannah, Georgia, Förenta staterna, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, Förenta staterna, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, Förenta staterna, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, Förenta staterna, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, Förenta staterna, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, Förenta staterna, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, Förenta staterna, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Island Urology
  - Lihue, Hawaii, Förenta staterna, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - ‘Aiea, Hawaii, Förenta staterna, 96701
    - Hawaii Cancer Care - Westridge
  - ‘Aiea, Hawaii, Förenta staterna, 96701
    - Pali Momi Medical Center
  - ‘Aiea, Hawaii, Förenta staterna, 96701
    - Queen's Cancer Center - Pearlridge
  - ‘Aiea, Hawaii, Förenta staterna, 96701
    - The Cancer Center of Hawaii-Pali Momi
- Idaho
  - Boise, Idaho, Förenta staterna, 83712
    - Saint Luke's Cancer Institute - Boise
  - Fruitland, Idaho, Förenta staterna, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, Förenta staterna, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, Förenta staterna, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Twin Falls, Idaho, Förenta staterna, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Bloomington, Illinois, Förenta staterna, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, Förenta staterna, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, Förenta staterna, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, Förenta staterna, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, Förenta staterna, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, Förenta staterna, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, Förenta staterna, 60611
    - Northwestern University
  - Chicago, Illinois, Förenta staterna, 60612
    - University of Illinois
  - Decatur, Illinois, Förenta staterna, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, Förenta staterna, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, Förenta staterna, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, Förenta staterna, 62401
    - Crossroads Cancer Center
  - Eureka, Illinois, Förenta staterna, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, Förenta staterna, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, Förenta staterna, 61401
    - Illinois CancerCare-Galesburg
  - Hines, Illinois, Förenta staterna, 60141
    - Edward Hines Jr VA Hospital
  - Kewanee, Illinois, Förenta staterna, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, Förenta staterna, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Macomb, Illinois, Förenta staterna, 61455
    - Illinois CancerCare-Macomb
  - Maywood, Illinois, Förenta staterna, 60153
    - Loyola University Medical Center
  - Mount Vernon, Illinois, Förenta staterna, 62864
    - SSM Health Good Samaritan
  - O'Fallon, Illinois, Förenta staterna, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, Förenta staterna, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, Förenta staterna, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, Förenta staterna, 61554
    - OSF Saint Francis Radiation Oncology at Pekin
  - Peoria, Illinois, Förenta staterna, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Förenta staterna, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, Förenta staterna, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, Förenta staterna, 61615
    - OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  - Peru, Illinois, Förenta staterna, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, Förenta staterna, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, Förenta staterna, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, Förenta staterna, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, Förenta staterna, 62702
    - Springfield Clinic
  - Springfield, Illinois, Förenta staterna, 62781
    - Springfield Memorial Hospital
  - Washington, Illinois, Förenta staterna, 61571
    - Illinois CancerCare - Washington
- Indiana
  - Carmel, Indiana, Förenta staterna, 46032
    - IU Health North Hospital
  - Indianapolis, Indiana, Förenta staterna, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Richmond, Indiana, Förenta staterna, 47374
    - Reid Health
- Iowa
  - Clive, Iowa, Förenta staterna, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, Förenta staterna, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Creston, Iowa, Förenta staterna, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, Förenta staterna, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Förenta staterna, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - West Des Moines, Iowa, Förenta staterna, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Garden City, Kansas, Förenta staterna, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, Förenta staterna, 67530
    - Central Care Cancer Center - Great Bend
- Kentucky
  - Lexington, Kentucky, Förenta staterna, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, Förenta staterna, 40509
    - CommonSpirit Saint Joseph Medical Center - East Lexington
  - Lexington, Kentucky, Förenta staterna, 40504
    - CommonSpirit Saint Joseph Hospital - Lexington
  - Louisville, Kentucky, Förenta staterna, 40202
    - Jewish Hospital
  - Louisville, Kentucky, Förenta staterna, 40245
    - UofL Health Medical Center Northeast
- Louisiana
  - Kenner, Louisiana, Förenta staterna, 70065
    - Ochsner Medical Center Kenner
  - New Orleans, Louisiana, Förenta staterna, 70121
    - Ochsner Medical Center Jefferson
- Maine
  - Bangor, Maine, Förenta staterna, 04401
    - Eastern Maine Medical Center
  - Bath, Maine, Förenta staterna, 04530
    - MaineHealth Coastal Cancer Treatment Center
  - Biddeford, Maine, Förenta staterna, 04005
    - MaineHealth Maine Medical Center - Biddeford
  - Brewer, Maine, Förenta staterna, 04412
    - Lafayette Family Cancer Center-EMMC
  - Portland, Maine, Förenta staterna, 04102
    - MaineHealth Maine Medical Center - Portland
  - Sanford, Maine, Förenta staterna, 04073
    - MaineHealth Cancer Care Center of York County
  - Sanford, Maine, Förenta staterna, 04073
    - MaineHealth Cancer Care and IV Therapy - Sanford
  - Scarborough, Maine, Förenta staterna, 04074
    - MaineHealth Maine Medical Center- Scarborough
  - South Portland, Maine, Förenta staterna, 04106
    - MaineHealth Cancer Care and IV Therapy - South Portland
- Massachusetts
  - Boston, Massachusetts, Förenta staterna, 02111
    - Tufts Medical Center
  - Boston, Massachusetts, Förenta staterna, 02118
    - Boston Medical Center
  - Lowell, Massachusetts, Förenta staterna, 01854
    - Lowell General Hospital
- Michigan
  - Ann Arbor, Michigan, Förenta staterna, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Brighton, Michigan, Förenta staterna, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, Förenta staterna, 48114
    - Trinity Health Medical Center - Brighton
  - Canton, Michigan, Förenta staterna, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Canton, Michigan, Förenta staterna, 48188
    - Trinity Health Medical Center - Canton
  - Caro, Michigan, Förenta staterna, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, Förenta staterna, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Chelsea, Michigan, Förenta staterna, 48118
    - Chelsea Hospital
  - Detroit, Michigan, Förenta staterna, 48236
    - Henry Ford Health Saint John Hospital
  - Flint, Michigan, Förenta staterna, 48503
    - Hurley Medical Center
  - Flint, Michigan, Förenta staterna, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, Förenta staterna, 48236
    - Henry Ford Saint John Hospital - Van Elslander
  - Lansing, Michigan, Förenta staterna, 48912
    - University of Michigan Health - Sparrow Lansing
  - Livonia, Michigan, Förenta staterna, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Macomb, Michigan, Förenta staterna, 48044
    - Henry Ford Saint John Hospital - Macomb Medical
  - Marlette, Michigan, Förenta staterna, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Novi, Michigan, Förenta staterna, 48374
    - Henry Ford Health Providence Novi Hospital
  - Pontiac, Michigan, Förenta staterna, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Pontiac, Michigan, Förenta staterna, 48341
    - Michigan Healthcare Professionals Pontiac
  - Saginaw, Michigan, Förenta staterna, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saginaw, Michigan, Förenta staterna, 48601
    - MyMichigan Medical Center Saginaw
  - Southfield, Michigan, Förenta staterna, 48075
    - Henry Ford Health Providence Southfield Hospital
  - Tawas City, Michigan, Förenta staterna, 48764
    - MyMichigan Medical Center Tawas
  - Warren, Michigan, Förenta staterna, 48093
    - Henry Ford Health Warren Hospital
  - West Branch, Michigan, Förenta staterna, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Ypsilanti, Michigan, Förenta staterna, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Bemidji, Minnesota, Förenta staterna, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, Förenta staterna, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, Förenta staterna, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, Förenta staterna, 55337
    - Minnesota Oncology - Burnsville
  - Coon Rapids, Minnesota, Förenta staterna, 55433
    - Mercy Hospital
  - Deer River, Minnesota, Förenta staterna, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, Förenta staterna, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, Förenta staterna, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, Förenta staterna, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, Förenta staterna, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, Förenta staterna, 55435
    - Fairview Southdale Hospital
  - Edina, Minnesota, Förenta staterna, 55435
    - Minnesota Oncology - Edina
  - Fergus Falls, Minnesota, Förenta staterna, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fosston, Minnesota, Förenta staterna, 56542
    - Essentia Health - Fosston
  - Fridley, Minnesota, Förenta staterna, 55432
    - Unity Hospital
  - Hibbing, Minnesota, Förenta staterna, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, Förenta staterna, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, Förenta staterna, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, Förenta staterna, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, Förenta staterna, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, Förenta staterna, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, Förenta staterna, 55454
    - Health Partners Inc
  - Monticello, Minnesota, Förenta staterna, 55362
    - Monticello Cancer Center
  - Park Rapids, Minnesota, Förenta staterna, 56470
    - Essentia Health - Park Rapids
  - Robbinsdale, Minnesota, Förenta staterna, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, Förenta staterna, 55905
    - Mayo Clinic in Rochester
  - Saint Louis Park, Minnesota, Förenta staterna, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, Förenta staterna, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, Förenta staterna, 55102
    - United Hospital
  - Sandstone, Minnesota, Förenta staterna, 55072
    - Essentia Health Sandstone
  - Shakopee, Minnesota, Förenta staterna, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, Förenta staterna, 55082
    - Lakeview Hospital
  - Virginia, Minnesota, Förenta staterna, 55792
    - Essentia Health Virginia Clinic
  - Waconia, Minnesota, Förenta staterna, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Förenta staterna, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, Förenta staterna, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Columbus, Mississippi, Förenta staterna, 39705
    - Baptist Memorial Hospital and Cancer Center-Golden Triangle
  - Grenada, Mississippi, Förenta staterna, 38901
    - Baptist Cancer Center-Grenada
  - New Albany, Mississippi, Förenta staterna, 38652
    - Baptist Memorial Hospital and Cancer Center-Union County
  - Oxford, Mississippi, Förenta staterna, 38655
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southhaven, Mississippi, Förenta staterna, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Ballwin, Missouri, Förenta staterna, 63011
    - Mercy Oncology and Hematology - Clayton-Clarkson
  - Bolivar, Missouri, Förenta staterna, 65613
    - Central Care Cancer Center - Bolivar
  - Cape Girardeau, Missouri, Förenta staterna, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, Förenta staterna, 63703
    - Mercy Cancer Center - Cape Girardeau
  - City of Saint Peters, Missouri, Förenta staterna, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Creve Coeur, Missouri, Förenta staterna, 63141
    - Siteman Cancer Center at West County Hospital
  - Farmington, Missouri, Förenta staterna, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, Förenta staterna, 65109
    - MU Health Care Goldschmidt Cancer Center
  - Joplin, Missouri, Förenta staterna, 64804
    - Freeman Health System
  - Joplin, Missouri, Förenta staterna, 64804
    - Mercy Hospital Joplin
  - Rolla, Missouri, Förenta staterna, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Rolla, Missouri, Förenta staterna, 65401
    - Phelps Health Delbert Day Cancer Institute
  - Saint Joseph, Missouri, Förenta staterna, 64506
    - Heartland Regional Medical Center
  - Sainte Genevieve, Missouri, Förenta staterna, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, Förenta staterna, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, Förenta staterna, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, Förenta staterna, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, Förenta staterna, 63129
    - Siteman Cancer Center-South County
  - St Louis, Missouri, Förenta staterna, 63136
    - Siteman Cancer Center at Christian Hospital
  - St Louis, Missouri, Förenta staterna, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, Förenta staterna, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, Förenta staterna, 63128
    - Mercy Hospital South
  - Sullivan, Missouri, Förenta staterna, 63080
    - Missouri Baptist Sullivan Hospital
- Montana
  - Missoula, Montana, Förenta staterna, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Bellevue, Nebraska, Förenta staterna, 68123
    - Nebraska Medicine-Bellevue
  - Grand Island, Nebraska, Förenta staterna, 68803
    - Nebraska Cancer Specialists/Oncology Hematology West PC
  - Kearney, Nebraska, Förenta staterna, 68847
    - CHI Health Good Samaritan
  - Omaha, Nebraska, Förenta staterna, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, Förenta staterna, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, Förenta staterna, 68118
    - Nebraska Medicine-Village Pointe
  - Omaha, Nebraska, Förenta staterna, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, Förenta staterna, 68130
    - Alegent Health Lakeside Hospital
- Nevada
  - Henderson, Nevada, Förenta staterna, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, Förenta staterna, 89074
    - Oncology Las Vegas - Henderson
  - Las Vegas, Nevada, Förenta staterna, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, Förenta staterna, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, Förenta staterna, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, Förenta staterna, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, Förenta staterna, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, Förenta staterna, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, Förenta staterna, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, Förenta staterna, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, Förenta staterna, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, Förenta staterna, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, Förenta staterna, 89183
    - OptumCare Cancer Care at Fort Apache
  - Reno, Nevada, Förenta staterna, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, Förenta staterna, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, Förenta staterna, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Lebanon, New Hampshire, Förenta staterna, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Jersey
  - Brick, New Jersey, Förenta staterna, 08724
    - Ocean University Medical Center
  - Long Branch, New Jersey, Förenta staterna, 07740
    - Monmouth Medical Center
  - Manahawkin, New Jersey, Förenta staterna, 08050
    - Southern Ocean County Medical Center
  - Neptune City, New Jersey, Förenta staterna, 07753
    - Jersey Shore Medical Center
  - New Brunswick, New Jersey, Förenta staterna, 08903
    - Rutgers Cancer Institute of New Jersey
  - Red Bank, New Jersey, Förenta staterna, 07701
    - Riverview Medical Center/Booker Cancer Center
  - Toms River, New Jersey, Förenta staterna, 08755
    - Community Medical Center
- New Mexico
  - Albuquerque, New Mexico, Förenta staterna, 87102
    - Lovelace Medical Center-Saint Joseph Square
  - Albuquerque, New Mexico, Förenta staterna, 87109
    - New Mexico Oncology Hematology Consultants
  - Albuquerque, New Mexico, Förenta staterna, 87106
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, Förenta staterna, 87110
    - Presbyterian Kaseman Hospital
  - Rio Rancho, New Mexico, Förenta staterna, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
- New York
  - Canandaigua, New York, Förenta staterna, 14424
    - Sands Cancer Center
  - Dansville, New York, Förenta staterna, 14437
    - Noyes Memorial Hospital/Myers Cancer Center
  - Glens Falls, New York, Förenta staterna, 12801
    - Glens Falls Hospital
  - Lake Success, New York, Förenta staterna, 11042
    - Northwell Health/Center for Advanced Medicine
  - Middletown, New York, Förenta staterna, 10940
    - Garnet Health Medical Center
  - New York, New York, Förenta staterna, 10065
    - NYP/Weill Cornell Medical Center
  - New York, New York, Förenta staterna, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, Förenta staterna, 14642
    - University of Rochester
  - Syracuse, New York, Förenta staterna, 13210
    - State University of New York Upstate Medical University
  - The Bronx, New York, Förenta staterna, 10461
    - Montefiore Medical Center-Einstein Campus
  - The Bronx, New York, Förenta staterna, 10467
    - Montefiore Medical Center - Moses Campus
  - The Bronx, New York, Förenta staterna, 10461
    - Montefiore Medical Center-Weiler Hospital
- North Carolina
  - Charlotte, North Carolina, Förenta staterna, 28204
    - Novant Health Presbyterian Medical Center
  - Huntersville, North Carolina, Förenta staterna, 28078
    - Novant Health Cancer Institute - Huntersville
  - Huntersville, North Carolina, Förenta staterna, 28078
    - Novant Health Presbyterian Medical Center Huntersville
  - Kernersville, North Carolina, Förenta staterna, 27284
    - Novant Health Cancer Institute - Kernersville
  - Matthews, North Carolina, Förenta staterna, 28105
    - Matthews Radiation Oncology Center
  - Matthews, North Carolina, Förenta staterna, 28105
    - Novant Health Cancer Institute - Matthews
  - Mooresville, North Carolina, Förenta staterna, 28117
    - Novant Health Cancer Institute - Mooresville
  - Mount Airy, North Carolina, Förenta staterna, 27030
    - Novant Health Cancer Institute - Mount Airy
  - North Wilkesboro, North Carolina, Förenta staterna, 28659
    - Novant Health Cancer Institute - Wilkesboro
  - Salisbury, North Carolina, Förenta staterna, 28144
    - Rowan Regional Medical Center
  - Statesville, North Carolina, Förenta staterna, 28625
    - Novant Health Cancer Institute - Statesville
  - Thomasville, North Carolina, Förenta staterna, 27360
    - Novant Health Cancer Institute - Thomasville
  - Winston-Salem, North Carolina, Förenta staterna, 27103
    - Novant Health Forsyth Medical Center
- North Dakota
  - Bismarck, North Dakota, Förenta staterna, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, Förenta staterna, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, Förenta staterna, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, Förenta staterna, 58122
    - Sanford Broadway Medical Center
  - Jamestown, North Dakota, Förenta staterna, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Beavercreek, Ohio, Förenta staterna, 45431
    - Indu and Raj Soin Medical Center
  - Boardman, Ohio, Förenta staterna, 44512
    - Saint Elizabeth Boardman Hospital
  - Centerville, Ohio, Förenta staterna, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, Förenta staterna, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Cincinnati, Ohio, Förenta staterna, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cincinnati, Ohio, Förenta staterna, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, Förenta staterna, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, Förenta staterna, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cleveland, Ohio, Förenta staterna, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, Förenta staterna, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, Förenta staterna, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, Förenta staterna, 43210
    - Ohio State University Comprehensive Cancer Center
  - Dayton, Ohio, Förenta staterna, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, Förenta staterna, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, Förenta staterna, 45415
    - Dayton Physician LLC - Englewood
  - Findlay, Ohio, Förenta staterna, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, Förenta staterna, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, Förenta staterna, 45840
    - Orion Cancer Care
  - Franklin, Ohio, Förenta staterna, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Franklin, Ohio, Förenta staterna, 45005
    - Dayton Physicians LLC-Atrium
  - Greenville, Ohio, Förenta staterna, 45331
    - Wayne Hospital
  - Greenville, Ohio, Förenta staterna, 45331
    - Dayton Physicians LLC-Wayne
  - Independence, Ohio, Förenta staterna, 44131
    - Cleveland Clinic Cancer Center Independence
  - Kettering, Ohio, Förenta staterna, 45429
    - Kettering Medical Center
  - Kettering, Ohio, Förenta staterna, 45409
    - Greater Dayton Cancer Center
  - Mansfield, Ohio, Förenta staterna, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Mayfield Heights, Ohio, Förenta staterna, 44124
    - Hillcrest Hospital Cancer Center
  - Sandusky, Ohio, Förenta staterna, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, Förenta staterna, 45504
    - Springfield Regional Cancer Center
  - Springfield, Ohio, Förenta staterna, 45504
    - Springfield Regional Medical Center
  - Strongsville, Ohio, Förenta staterna, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Sylvania, Ohio, Förenta staterna, 43560
    - ProMedica Flower Hospital
  - Toledo, Ohio, Förenta staterna, 43606
    - ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  - Troy, Ohio, Förenta staterna, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, Förenta staterna, 45373
    - Dayton Physicians LLC - Troy
  - Warren, Ohio, Förenta staterna, 44484
    - Saint Joseph Warren Hospital
  - Warrensville Heights, Ohio, Förenta staterna, 44122
    - South Pointe Hospital
  - West Chester, Ohio, Förenta staterna, 45069
    - University of Cincinnati Cancer Center-West Chester
  - Wooster, Ohio, Förenta staterna, 44691
    - Cleveland Clinic Wooster Family Health and Surgery Center
  - Youngstown, Ohio, Förenta staterna, 44501
    - Saint Elizabeth Youngstown Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Förenta staterna, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Bend, Oregon, Förenta staterna, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, Förenta staterna, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, Förenta staterna, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, Förenta staterna, 97420
    - Bay Area Hospital
  - Newberg, Oregon, Förenta staterna, 97132
    - Providence Newberg Medical Center
  - Portland, Oregon, Förenta staterna, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, Förenta staterna, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Allentown, Pennsylvania, Förenta staterna, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Allentown, Pennsylvania, Förenta staterna, 18104
    - Saint Luke's Cancer Center - Allentown
  - Altoona, Pennsylvania, Förenta staterna, 16601
    - UPMC Altoona
  - Beaver, Pennsylvania, Förenta staterna, 15009
    - UPMC-Heritage Valley Health System Beaver
  - Bethlehem, Pennsylvania, Förenta staterna, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Bethlehem, Pennsylvania, Förenta staterna, 18015
    - Saint Luke's University Hospital-Bethlehem Campus
  - Butler, Pennsylvania, Förenta staterna, 16001
    - UPMC Hillman Cancer Center at Butler Health System
  - Camp Hill, Pennsylvania, Förenta staterna, 17011
    - UPMC Camp Hill
  - Carlisle, Pennsylvania, Förenta staterna, 17015
    - Carlisle Regional Cancer Center
  - Chadds Ford, Pennsylvania, Förenta staterna, 19317
    - Christiana Care Health System-Concord Health Center
  - Danville, Pennsylvania, Förenta staterna, 17822
    - Geisinger Medical Center
  - East Stroudsburg, Pennsylvania, Förenta staterna, 18301
    - Pocono Medical Center
  - Easton, Pennsylvania, Förenta staterna, 18045
    - Saint Luke's Hospital-Anderson Campus
  - Erie, Pennsylvania, Förenta staterna, 16505
    - UPMC Hillman Cancer Center Erie
  - Farrell, Pennsylvania, Förenta staterna, 16121
    - UPMC Cancer Center at UPMC Horizon
  - Greensburg, Pennsylvania, Förenta staterna, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Harrisburg, Pennsylvania, Förenta staterna, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Hershey, Pennsylvania, Förenta staterna, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Indiana, Pennsylvania, Förenta staterna, 15701
    - IRMC Cancer Center
  - Jefferson Hills, Pennsylvania, Förenta staterna, 15025
    - Jefferson Hospital
  - Johnstown, Pennsylvania, Förenta staterna, 15901
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - Lewisburg, Pennsylvania, Förenta staterna, 17837
    - Geisinger Medical Oncology-Lewisburg
  - McKeesport, Pennsylvania, Förenta staterna, 15132
    - UPMC Cancer Center at UPMC McKeesport
  - Monroeville, Pennsylvania, Förenta staterna, 15146
    - Forbes Hospital
  - Monroeville, Pennsylvania, Förenta staterna, 15146
    - UPMC Hillman Cancer Center - Monroeville
  - Monroeville, Pennsylvania, Förenta staterna, 15146
    - UPMC Cancer Center - Monroeville
  - Moon Township, Pennsylvania, Förenta staterna, 15108
    - UPMC Hillman Cancer Center in Coraopolis
  - Mount Pleasant, Pennsylvania, Förenta staterna, 15666
    - UPMC Hillman Cancer Center - Part of Frick Hospital
  - N. Huntingdon, Pennsylvania, Förenta staterna, 15642
    - Arnold Palmer Cancer Center Medical Oncology Norwin
  - Natrona Heights, Pennsylvania, Förenta staterna, 15065
    - Allegheny Valley Hospital
  - New Castle, Pennsylvania, Förenta staterna, 16105
    - UPMC Hillman Cancer Center - New Castle
  - Philadelphia, Pennsylvania, Förenta staterna, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Pittsburgh, Pennsylvania, Förenta staterna, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15232
    - UPMC Hillman Cancer Center
  - Pittsburgh, Pennsylvania, Förenta staterna, 15213
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15232
    - UPMC-Shadyside Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15215
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, Förenta staterna, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Pottstown, Pennsylvania, Förenta staterna, 19464
    - Pottstown Hospital
  - Seneca, Pennsylvania, Förenta staterna, 16346
    - UPMC Cancer Center at UPMC Northwest
  - Uniontown, Pennsylvania, Förenta staterna, 15401
    - UPMC Uniontown Hospital Radiation Oncology
  - Uniontown, Pennsylvania, Förenta staterna, 15401
    - UPMC Cancer Center-Uniontown
  - Washington, Pennsylvania, Förenta staterna, 15301
    - UPMC Washington Hospital Radiation Oncology
  - Washington, Pennsylvania, Förenta staterna, 15301
    - UPMC Cancer Center-Washington
  - West Mifflin, Pennsylvania, Förenta staterna, 15122
    - UPMC West Mifflin-Cancer Center Jefferson
  - West Reading, Pennsylvania, Förenta staterna, 19611
    - Reading Hospital
  - Wexford, Pennsylvania, Förenta staterna, 15090
    - Wexford Health and Wellness Pavilion
  - York, Pennsylvania, Förenta staterna, 17408
    - UPMC Memorial
- Rhode Island
  - East Greenwich, Rhode Island, Förenta staterna, 02818
    - Rhode Island Hospital at East Greenwich
  - Newport, Rhode Island, Förenta staterna, 02840
    - Newport Hospital
  - Providence, Rhode Island, Förenta staterna, 02903
    - Rhode Island Hospital
- South Carolina
  - Charleston, South Carolina, Förenta staterna, 29425
    - Medical University of South Carolina
  - Greenville, South Carolina, Förenta staterna, 29607
    - Saint Francis Cancer Center
  - Greenville, South Carolina, Förenta staterna, 29601
    - Saint Francis Hospital
- South Dakota
  - Sioux Falls, South Dakota, Förenta staterna, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Förenta staterna, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, Förenta staterna, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Collierville, Tennessee, Förenta staterna, 38017
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Memphis, Tennessee, Förenta staterna, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
  - Nashville, Tennessee, Förenta staterna, 37232
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Bryan, Texas, Förenta staterna, 77802
    - Saint Joseph Regional Cancer Center
  - Dallas, Texas, Förenta staterna, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, Förenta staterna, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Fort Worth, Texas, Förenta staterna, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Richardson, Texas, Förenta staterna, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
- Utah
  - Salt Lake City, Utah, Förenta staterna, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, Förenta staterna, 84106
    - University of Utah Sugarhouse Health Center
- Vermont
  - Berlin Corners, Vermont, Förenta staterna, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, Förenta staterna, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, Förenta staterna, 05405
    - University of Vermont and State Agricultural College
  - Saint Johnsbury, Vermont, Förenta staterna, 05819
    - Dartmouth Cancer Center - North
- Virginia
  - Charlottesville, Virginia, Förenta staterna, 22908
    - University of Virginia Cancer Center
  - Richmond, Virginia, Förenta staterna, 23229
    - Virginia Cancer Institute
  - Richmond, Virginia, Förenta staterna, 23298
    - VCU Massey Comprehensive Cancer Center
  - South Hill, Virginia, Förenta staterna, 23970
    - VCU Community Memorial Health Center
- Washington
  - Aberdeen, Washington, Förenta staterna, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellevue, Washington, Förenta staterna, 98004
    - Overlake Medical Center
  - Bellingham, Washington, Förenta staterna, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Burien, Washington, Förenta staterna, 98166
    - Saint Anne Hospital
  - Centralia, Washington, Förenta staterna, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, Förenta staterna, 98026
    - Swedish Cancer Institute-Edmonds
  - Everett, Washington, Förenta staterna, 98201
    - Providence Regional Cancer Partnership
  - Issaquah, Washington, Förenta staterna, 98029
    - Swedish Cancer Institute-Issaquah
  - Lacey, Washington, Förenta staterna, 98503
    - Providence Regional Cancer System-Lacey
  - Longview, Washington, Förenta staterna, 98632
    - PeaceHealth Saint John Medical Center
  - Renton, Washington, Förenta staterna, 98055
    - Valley Medical Center
  - Seattle, Washington, Förenta staterna, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, Förenta staterna, 98122
    - Swedish Medical Center-First Hill
  - Sedro-Woolley, Washington, Förenta staterna, 98284
    - PeaceHealth United General Medical Center
  - Silverdale, Washington, Förenta staterna, 98383
    - Saint Joseph Medical Center Hematology and Oncology - Silverdale
  - Tacoma, Washington, Förenta staterna, 98405
    - Northwest Medical Specialties PLLC
  - Vancouver, Washington, Förenta staterna, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, Förenta staterna, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yakima, Washington, Förenta staterna, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - Bridgeport, West Virginia, Förenta staterna, 26330
    - United Hospital Center
  - Charleston, West Virginia, Förenta staterna, 25304
    - Vandalia Health/CAMC Institute for Academic Medicine
  - Morgantown, West Virginia, Förenta staterna, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, Förenta staterna, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Appleton, Wisconsin, Förenta staterna, 54911
    - ThedaCare Regional Cancer Center
  - Ashland, Wisconsin, Förenta staterna, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, Förenta staterna, 54806
    - Northwest Wisconsin Cancer Center
  - Burlington, Wisconsin, Förenta staterna, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Eau Claire, Wisconsin, Förenta staterna, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Eau Claire, Wisconsin, Förenta staterna, 54701
    - HSHS Sacred Heart Hospital
  - Fond du Lac, Wisconsin, Förenta staterna, 54937
    - Aurora Health Center-Fond du Lac
  - Germantown, Wisconsin, Förenta staterna, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, Förenta staterna, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, Förenta staterna, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, Förenta staterna, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, Förenta staterna, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, Förenta staterna, 54301
    - Bellin Memorial Hospital
  - Hayward, Wisconsin, Förenta staterna, 54843
    - Essentia Health-Hayward Clinic
  - Johnson Creek, Wisconsin, Förenta staterna, 53038
    - University of Wisconsin Carbone Cancer Center - Johnson Creek
  - Kenosha, Wisconsin, Förenta staterna, 53142
    - Aurora Cancer Care-Kenosha South
  - Madison, Wisconsin, Förenta staterna, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Marinette, Wisconsin, Förenta staterna, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, Förenta staterna, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, Förenta staterna, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, Förenta staterna, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, Förenta staterna, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, Förenta staterna, 54548
    - Marshfield Medical Center - Minocqua
  - New Richmond, Wisconsin, Förenta staterna, 54017
    - Cancer Center of Western Wisconsin
  - Oshkosh, Wisconsin, Förenta staterna, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, Förenta staterna, 53406
    - Aurora Cancer Care-Racine
  - Rice Lake, Wisconsin, Förenta staterna, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, Förenta staterna, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Spooner, Wisconsin, Förenta staterna, 54801
    - Essentia Health-Spooner Clinic
  - Stevens Point, Wisconsin, Förenta staterna, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Sturgeon Bay, Wisconsin, Förenta staterna, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, Förenta staterna, 53066
    - Aurora Medical Center in Summit
  - Superior, Wisconsin, Förenta staterna, 54880
    - Essentia Health Saint Mary's Hospital - Superior
  - Two Rivers, Wisconsin, Förenta staterna, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Wauwatosa, Wisconsin, Förenta staterna, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, Förenta staterna, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, Förenta staterna, 54476
    - Marshfield Medical Center - Weston

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

STEP 1 RANDOMIZATION: Patients must be age >= 18 years
STEP 1 RANDOMIZATION: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)
STEP 1 RANDOMIZATION: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
STEP 1 RANDOMIZATION: Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy
STEP 1 RANDOMIZATION: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Hemoglobin (Hgb) >= 9 g/dL (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Leukocytes >= 3,000/mm^3 (within less than or equal to 14 days prior to randomization)
STEP 1 RANDOMIZATION: Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy
STEP 1 RANDOMIZATION: Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy
STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy
STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving radiation therapy
STEP 1 RANDOMIZATION: Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, must be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome must be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies must be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
STEP 1 RANDOMIZATION: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
STEP 1 RANDOMIZATION: Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:
- Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR
- Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
- Date of last evidence of disease
STEP 1 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
STEP 1 RANDOMIZATION: Patients must have adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs
STEP 1 RANDOMIZATION: For patients with evidence of uncontrolled CHF, myocardial infarction (MI), cardiomyopathy, or myositis, require a cardiac evaluation and clearance including lab tests and cardiology consultation (EKG, creatinine phosphokinase [CPK], troponin, and echocardiogram)
STEP 1 RANDOMIZATION: Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility
STEP 1 RANDOMIZATION: Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen
STEP 1 RANDOMIZATION: Patients must not be receiving any other investigational agents
STEP 1 RANDOMIZATION: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
STEP 1 RANDOMIZATION: Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants from carboplatin, paclitaxel, ipilimumab or nivolumab
- All patients of childbearing potential must have a blood test or urine study done within 2 weeks prior to randomization to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of starting nivolumab to rule out pregnancy
- A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
STEP 1 RANDOMIZATION: Patients of childbearing potential must not expect to conceive children by either abstaining from sexual intercourse for the duration of their participation in the study or by agreeing to use both double barrier contraception and birth control pills or implants for at least one month prior to the start of the study drug and continuing for 5 months after the last dose of study drug. Investigators shall counsel patients of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy
STEP 2 RANDOMIZATION: Patient registration must not exceed 12 weeks from time of esophagectomy
STEP 2 RANDOMIZATION: Patients must have a post-operative ECOG performance status of 0-2
STEP 2 RANDOMIZATION: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
STEP 2 RANDOMIZATION: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
STEP 2 RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
STEP 2 RANDOMIZATION: AST (SGOT)/ ALT (SGPT) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
STEP 2 RANDOMIZATION: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
STEP 2 RANDOMIZATION: Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical CT scan. Patients must also have a negative surgical margin (R0 resection)
STEP 2 RANDOMIZATION: Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
STEP 2 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
STEP 2 RANDOMIZATION: Patients must not be receiving any other investigational agents
STEP 2 RANDOMIZATION: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
STEP 2 RANDOMIZATION: Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risks for adverse events in nursing infants from nivolumab or ipilimumab
- All patients of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to randomization to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy
STEP 2 RANDOMIZATION: Patients of childbearing potential must not expect to conceive children by either abstaining from sexual intercourse for the duration of their participation in the study or by agreeing to use both double barrier contraception and birth control pills or implants for at least one month prior to the start of the study drug and continuing for 5 months after the last dose of study drug. Investigators shall counsel patients of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm Deltagargrupp / Arm En grupp eller undergrupp av deltagare i en klinisk prövning som får en specifik intervention/behandling, eller ingen intervention, enligt prövningens protokoll.	Intervention / Behandling Intervention / Behandling En process eller handling som är i fokus för en klinisk studie. Interventioner inkluderar läkemedel, medicinsk utrustning, procedurer, vacciner och andra produkter som antingen är undersökta eller redan tillgängliga. Interventioner kan också innefatta icke-invasiva tillvägagångssätt, såsom utbildning eller modifiering av kost och träning.
Experimentell: Arm A (carboplatin, paclitaxel, radiation therapy) Patients receive carboplatin IV and paclitaxel IV once weekly and undergo radiation therapy QD (Monday-Friday) beginning on day 1 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.	Läkemedel: Carboplatin Given IV Andra namn: Blastocarb Carboplat Carboplatin Hexal Carboplatino Karboplatina Karbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatina Paraplatin Paraplatin AQ Platinwas Ribocarbo JM8 Läkemedel: Paclitaxel Given IV Andra namn: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Procedur: Computed Tomography Undergo CT scan Andra namn: CT KATT Datortomografi Beräknad axiell tomografi Datoriserad axialtomografi tomografi Datoriserad axiell tomografi (förfarande) Datortomografi (CT) skanning Diagnostisk kattskanning Diagnostisk kattskanningstjänsttyp Procedur: Positron Emission Tomography Undergo PET scan Andra namn: Medicinsk avbildning, Positron Emission Tomografi SÄLLSKAPSDJUR Djur Scan Positron Emission Tomography Scan Positronemissionstomografi PT Positronemissionstomografi (förfarande) Procedur: Biospecimen Collection Undergo collection of blood sample Andra namn: Biologisk provsamling Bioprov insamlat Provsamling Provuppsamling Strålning: Radiation Therapy Undergo radiation therapy Andra namn: Cancer Strålbehandling ENERGY_TYPE Bestråla Bestrålat Bestrålning Strålning Strålterapi, NOS Radioterapeutika Strålbehandling RT Terapi, strålning Energityp
Experimentell: Arm B (carboplatin, paclitaxel, radiation therapy, nivolumab) Patients receive carboplatin, paclitaxel, and radiation therapy as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.	Läkemedel: Carboplatin Given IV Andra namn: Blastocarb Carboplat Carboplatin Hexal Carboplatino Karboplatina Karbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatina Paraplatin Paraplatin AQ Platinwas Ribocarbo JM8 Läkemedel: Paclitaxel Given IV Andra namn: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Biologisk: Nivolumab Given IV Andra namn: BMS-936558 MDX-1106 NIVO ONO-4538 Opdivo CMAB819 Nivolumab Biosimilar CMAB819 MDX 1106 MDX1106 BMS 936558 ABP 206 Nivolumab Biosimilar ABP 206 BCD-263 Nivolumab Biosimilar BCD-263 BMS936558 ONO 4538 ONO4538 Procedur: Computed Tomography Undergo CT scan Andra namn: CT KATT Datortomografi Beräknad axiell tomografi Datoriserad axialtomografi tomografi Datoriserad axiell tomografi (förfarande) Datortomografi (CT) skanning Diagnostisk kattskanning Diagnostisk kattskanningstjänsttyp Procedur: Positron Emission Tomography Undergo PET scan Andra namn: Medicinsk avbildning, Positron Emission Tomografi SÄLLSKAPSDJUR Djur Scan Positron Emission Tomography Scan Positronemissionstomografi PT Positronemissionstomografi (förfarande) Procedur: Biospecimen Collection Undergo collection of blood sample Andra namn: Biologisk provsamling Bioprov insamlat Provsamling Provuppsamling Strålning: Radiation Therapy Undergo radiation therapy Andra namn: Cancer Strålbehandling ENERGY_TYPE Bestråla Bestrålat Bestrålning Strålning Strålterapi, NOS Radioterapeutika Strålbehandling RT Terapi, strålning Energityp
Experimentell: Arm C (nivolumab) Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.	Biologisk: Nivolumab Given IV Andra namn: BMS-936558 MDX-1106 NIVO ONO-4538 Opdivo CMAB819 Nivolumab Biosimilar CMAB819 MDX 1106 MDX1106 BMS 936558 ABP 206 Nivolumab Biosimilar ABP 206 BCD-263 Nivolumab Biosimilar BCD-263 BMS936558 ONO 4538 ONO4538 Procedur: Computed Tomography Undergo CT scan Andra namn: CT KATT Datortomografi Beräknad axiell tomografi Datoriserad axialtomografi tomografi Datoriserad axiell tomografi (förfarande) Datortomografi (CT) skanning Diagnostisk kattskanning Diagnostisk kattskanningstjänsttyp Procedur: Biospecimen Collection Undergo collection of blood sample Andra namn: Biologisk provsamling Bioprov insamlat Provsamling Provuppsamling
Experimentell: Arm D (nivolumab, ipilimumab) Patients receive nivolumab as in Arm C and receive ipilimumab IV over 90 minutes on day 1 of cycles 1 and 4 and day 15 of cycles 2 and 5. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.	Biologisk: Ipilimumab Given IV Andra namn: Anti-cytotoxisk T-lymfocyt-associerad antigen-4 monoklonal antikropp BMS-734016 Ipilimumab Biosimilar CS1002 MDX-010 MDX-CTLA4 Yervoy MDX010 BMS734016 BMS 734016 MDX 010 Biologisk: Nivolumab Given IV Andra namn: BMS-936558 MDX-1106 NIVO ONO-4538 Opdivo CMAB819 Nivolumab Biosimilar CMAB819 MDX 1106 MDX1106 BMS 936558 ABP 206 Nivolumab Biosimilar ABP 206 BCD-263 Nivolumab Biosimilar BCD-263 BMS936558 ONO 4538 ONO4538 Procedur: Computed Tomography Undergo CT scan Andra namn: CT KATT Datortomografi Beräknad axiell tomografi Datoriserad axialtomografi tomografi Datoriserad axiell tomografi (förfarande) Datortomografi (CT) skanning Diagnostisk kattskanning Diagnostisk kattskanningstjänsttyp Procedur: Biospecimen Collection Undergo collection of blood sample Andra namn: Biologisk provsamling Bioprov insamlat Provsamling Provuppsamling

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Pathologic complete response (Step I) Tidsram: Up to 5 weeks	The study with compare the pathologic complete response of Arm A and Arm B using a one-sided 0.10 level chi-squared test for proportions.	Up to 5 weeks
Disease-free survival (DFS) (Step 2) Tidsram: From the adjuvant treatment randomization assessed for up to 7 years	DFS measured from the adjuvant treatment randomization will be the endpoint of the adjuvant portion of the study and to achieve the desired power it is expected that patients will be followed for an additional year post completion of accrual to the adjuvant portion. The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.	From the adjuvant treatment randomization assessed for up to 7 years

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Incidence of adverse events Tidsram: Up to 7 years	Graded according to Common Terminology Criteria for Adverse Events version 5.0. Toxicity will be evaluated among all treated patients regardless of eligibility and interim analyses of toxicity are performed twice yearly. The study will have sufficient precision to provide 95% confidence intervals on toxicity	Up to 7 years
Overall survival Tidsram: From the time of first randomization up to 7 years	Analyses will be descriptive in nature and will not follow any formal interim monitoring.	From the time of first randomization up to 7 years
DFS Tidsram: From the time of first randomization up to 7 years	The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.	From the time of first randomization up to 7 years

Andra resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Percent change in mean volumetric apparent diffusion coefficient (ADC) Tidsram: Baseline to mid-treatment	The study will assess the area under the receiver operating characteristic curve of the changes of ADC value.	Baseline to mid-treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

Huvudutredare: Jennifer R Eads, ECOG-ACRIN Cancer Research Group

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 maj 2019

Primärt slutförande (Beräknad)

31 mars 2027

Avslutad studie (Beräknad)

31 mars 2027

Studieregistreringsdatum

Först inskickad

27 juli 2018

Först inskickad som uppfyllde QC-kriterierna

27 juli 2018

Första postat (Faktisk)

30 juli 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 november 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

NCI-2018-01575
U10CA180820 (U.S.S. NIH-anslag/kontrakt)
NCI-2018-01575 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
EA2174 (Annan identifierare: CTEP)
EA2174 (Annan identifierare: ECOG-ACRIN Cancer Research Group)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

IPD-planbeskrivning

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Nivolumab och Ipilimumab vid behandling av patienter med esofageal och gastroesofageal Junction Adenocarcinoma som genomgår operation

En fas II/III-studie av perioperativt nivolumab och ipilimumab hos patienter med lokalt esofagus- och gastroesofagealt adenokarcinom

Studieöversikt

Status

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Studietyp

Inskrivning (Beräknad)

Fas

Kontakter och platser

Studieorter

Deltagandekriterier

Urvalskriterier

Åldrar som är berättigade till studier

Tar emot friska volontärer

Kön som är behöriga för studier

Beskrivning

Studieplan

Hur är studien utformad?

Designdetaljer

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm

Intervention / Behandling

Vad mäter studien?

Primära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Sekundära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Andra resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Samarbetspartners och utredare

Sponsor

Utredare

Studieavstämningsdatum

Studera stora datum

Studiestart (Faktisk)

Primärt slutförande (Beräknad)

Avslutad studie (Beräknad)

Studieregistreringsdatum

Först inskickad

Först inskickad som uppfyllde QC-kriterierna

Första postat (Faktisk)

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

Senast verifierad

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

IPD-planbeskrivning

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt