- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811015
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPSCC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of overall survival (OS).
SECONDARY OBJECTIVES:
I. To further assess the efficacy of nivolumab compared with observation in terms of:
Ia. To evaluate treatment effect within the subset of patients tested as PD-L1+ .
Ib. To evaluate the prognostic effect of baseline saliva and/or plasma HPV status .
Ic. To evaluate the prognostic effect of mutation burden among patients on the nivolumab arm.
Id. To evaluate the association of 12-week post therapy fludeoxyglucose F-18 (FDG) positron emission tomography(PET)/computed tomography (CT) OS and progression free survival (PFS).
Ie. To establish the prognostic value of standardized uptake value (SUV) max of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS (and/or PFS).
If. To correlate SUV max of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive versus [vs.] negative).
Ig. To compare the PET based therapy response assessment (Hopkins criteria) to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessment at 12 week post chemoradiation therapy, for patients who have a PET/CT scan at 12 weeks.
II. To assess the efficacy of concurrent definitive therapy followed by nivolumab in terms of progression free survival (PFS).
OUTLINE: Patients are randomized to Arm A or Arm B. Patients in Arm B may cross-over to Arm C with clearly documented disease progression.
ARM A: Patients receive cisplatin intravenously (IV) over 60 minutes weekly and intensity modulated radiation therapy (IMRT) 5 days a week for 7 weeks for a total of 35 fractions. Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation. Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy.
ARM C: Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
All patients undergo computed tomography (CT) or Fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT scans throughout the trial. Patients may undergo echocardiography (ECHO) as clinically indicated. Additionally, patients undergo blood sample collection during screening.
After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually for a total of 10 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Fairhope, Alabama, United States, 36532
- Thomas Hospital
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Mobile, Alabama, United States, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, United States, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, United States, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, United States, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, United States, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, United States, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, United States, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, United States, 99504
- Anchorage Radiation Therapy Center
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Fairbanks, Alaska, United States, 99701
- Fairbanks Memorial Hospital
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Arizona
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Goodyear, Arizona, United States, 85338
- CTCA at Western Regional Medical Center
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Kingman, Arizona, United States, 86401
- Kingman Regional Medical Center
-
Phoenix, Arizona, United States, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, United States, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, United States, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
-
Antioch, California, United States, 94531
- Kaiser Permanente-Deer Valley Medical Center
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Arroyo Grande, California, United States, 93420
- PCR Oncology
-
Arroyo Grande, California, United States, 93420
- Mission Hope Medical Oncology - Arroyo Grande
-
Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
-
Carmichael, California, United States, 95608
- Mercy San Juan Medical Center
-
Carmichael, California, United States, 95608
- Mercy Cancer Center - Carmichael
-
Dublin, California, United States, 94568
- Kaiser Permanente Dublin
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Dublin, California, United States, 94568
- Epic Care-Dublin
-
Elk Grove, California, United States, 95758
- Mercy Cancer Center - Elk Grove
-
Emeryville, California, United States, 94608
- Bay Area Breast Surgeons Inc
-
Emeryville, California, United States, 94608
- Epic Care Partners in Cancer Care
-
Fremont, California, United States, 94538
- Kaiser Permanente-Fremont
-
Fresno, California, United States, 93720
- Kaiser Permanente-Fresno
-
Fresno, California, United States, 93720
- Fresno Cancer Center
-
Long Beach, California, United States, 90822
- Tibor Rubin VA Medical Center
-
Martinez, California, United States, 94553-3156
- Contra Costa Regional Medical Center
-
Merced, California, United States, 95340
- Mercy Cancer Center
-
Modesto, California, United States, 95356
- Kaiser Permanente-Modesto
-
Napa, California, United States, 94558
- Providence Queen of The Valley
-
Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
-
Oakland, California, United States, 94611
- Kaiser Permanente Oakland-Broadway
-
Oakland, California, United States, 94609
- Alta Bates Summit Medical Center - Summit Campus
-
Oakland, California, United States, 94609
- Bay Area Tumor Institute
-
Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
-
Rancho Cordova, California, United States, 95670
- Kaiser Permanente-Rancho Cordova Cancer Center
-
Redwood City, California, United States, 94063
- Kaiser Permanente-Redwood City
-
Richmond, California, United States, 94801
- Kaiser Permanente-Richmond
-
Rocklin, California, United States, 95765
- Mercy Cancer Center - Rocklin
-
Rohnert Park, California, United States, 94928
- Rohnert Park Cancer Center
-
Roseville, California, United States, 95678
- The Permanente Medical Group-Roseville Radiation Oncology
-
Roseville, California, United States, 95661
- Kaiser Permanente-Roseville
-
Sacramento, California, United States, 95814
- Kaiser Permanente Downtown Commons
-
Sacramento, California, United States, 95823
- South Sacramento Cancer Center
-
Sacramento, California, United States, 95816
- Mercy Cancer Center - Sacramento
-
Salinas, California, United States, 93901
- Salinas Valley Memorial
-
San Diego, California, United States, 92134
- Naval Medical Center -San Diego
-
San Diego, California, United States, 92103
- UC San Diego Medical Center - Hillcrest
-
San Francisco, California, United States, 94115
- Kaiser Permanente-San Francisco
-
San Jose, California, United States, 95119
- Kaiser Permanente-Santa Teresa-San Jose
-
San Leandro, California, United States, 94577
- Kaiser Permanente San Leandro
-
San Luis Obispo, California, United States, 93401
- Pacific Central Coast Health Center-San Luis Obispo
-
San Rafael, California, United States, 94903
- Kaiser San Rafael-Gallinas
-
Santa Clara, California, United States, 95051
- Kaiser Permanente Medical Center - Santa Clara
-
Santa Maria, California, United States, 93444
- Mission Hope Medical Oncology - Santa Maria
-
Santa Rosa, California, United States, 95403
- Kaiser Permanente-Santa Rosa
-
Santa Rosa, California, United States, 95403
- Providence Medical Foundation - Santa Rosa
-
South San Francisco, California, United States, 94080
- Kaiser Permanente Cancer Treatment Center
-
South San Francisco, California, United States, 94080
- Kaiser Permanente-South San Francisco
-
Stockton, California, United States, 95210
- Kaiser Permanente-Stockton
-
Vacaville, California, United States, 95688
- Kaiser Permanente Medical Center-Vacaville
-
Vallejo, California, United States, 94589
- Kaiser Permanente-Vallejo
-
Walnut Creek, California, United States, 94596
- Kaiser Permanente-Walnut Creek
-
Walnut Creek, California, United States, 94597
- Epic Care Cyberknife Center
-
Woodland, California, United States, 95695
- Woodland Memorial Hospital
-
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Colorado
-
Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers-Aurora
-
Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
-
Aurora, Colorado, United States, 80045
- UCHealth University of Colorado Hospital
-
Boulder, Colorado, United States, 80303
- Boulder Community Foothills Hospital
-
Boulder, Colorado, United States, 80304
- Rocky Mountain Cancer Centers-Boulder
-
Centennial, Colorado, United States, 80112
- Rocky Mountain Cancer Centers - Centennial
-
Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, United States, 80909
- UCHealth Memorial Hospital Central
-
Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers-Penrose
-
Colorado Springs, Colorado, United States, 80920
- Memorial Hospital North
-
Colorado Springs, Colorado, United States, 80923
- Saint Francis Cancer Center
-
Denver, Colorado, United States, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, United States, 80220
- Rose Medical Center
-
Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers-Rose
-
Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, United States, 80204
- Cancer Center of Colorado at Sloan's Lake
-
Denver, Colorado, United States, 80209
- The Women's Imaging Center
-
Denver, Colorado, United States, 80206
- National Jewish Health-Main Campus
-
Denver, Colorado, United States, 80220
- Western Surgical Care
-
Denver, Colorado, United States, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
-
Denver, Colorado, United States, 80210
- AdventHealth Porter
-
Durango, Colorado, United States, 81301
- Mercy Medical Center
-
Durango, Colorado, United States, 81301
- CommonSpirit Cancer Center Mercy
-
Englewood, Colorado, United States, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, United States, 80113
- Swedish Medical Center
-
Englewood, Colorado, United States, 80113
- Rocky Mountain Cancer Centers - Swedish
-
Englewood, Colorado, United States, 80113
- The Melanoma and Skin Cancer Institute
-
Fort Collins, Colorado, United States, 80524
- Poudre Valley Hospital
-
Fort Collins, Colorado, United States, 80528
- Cancer Care and Hematology-Fort Collins
-
Golden, Colorado, United States, 80401
- National Jewish Health-Western Hematology Oncology
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Grand Junction, Colorado, United States, 81501
- Saint Mary's Hospital and Regional Medical Center
-
Greeley, Colorado, United States, 80631
- UCHealth Greeley Hospital
-
Greeley, Colorado, United States, 80631
- Banner North Colorado Medical Center
-
Lafayette, Colorado, United States, 80026
- Good Samaritan Hospital - Cancer Centers of Colorado
-
Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, United States, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Centers-Littleton
-
Littleton, Colorado, United States, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, United States, 80501
- Longmont United Hospital
-
Longmont, Colorado, United States, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, United States, 80538
- Medical Center of the Rockies
-
Loveland, Colorado, United States, 80539
- Banner North Colorado Medical Center - Loveland Campus
-
Parker, Colorado, United States, 80138
- AdventHealth Parker
-
Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
-
Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers-Thornton
-
Thornton, Colorado, United States, 80260
- National Jewish Health-Northern Hematology Oncology
-
Wheat Ridge, Colorado, United States, 80401
- Intermountain Health Lutheran Hospital
-
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Connecticut
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Greenwich, Connecticut, United States, 06830
- Smilow Cancer Hospital Care Center at Greenwich
-
Guilford, Connecticut, United States, 06437
- Smilow Cancer Hospital Care Center - Guilford
-
New Haven, Connecticut, United States, 06520
- Yale University
-
New Haven, Connecticut, United States, 06510
- Smilow Cancer Center/Yale-New Haven Hospital
-
North Haven, Connecticut, United States, 06473
- Yale-New Haven Hospital North Haven Medical Center
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Orange, Connecticut, United States, 06477
- Smilow Cancer Hospital-Orange Care Center
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Trumbull, Connecticut, United States, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Waterford, Connecticut, United States, 06385
- Smilow Cancer Hospital Care Center - Waterford
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Delaware
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Lewes, Delaware, United States, 19958
- Beebe Medical Center
-
Millville, Delaware, United States, 19967
- Beebe South Coastal Health Campus
-
Newark, Delaware, United States, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, United States, 19713
- Delaware Clinical and Laboratory Physicians PA
-
Newark, Delaware, United States, 19713
- Medical Oncology Hematology Consultants PA
-
Newark, Delaware, United States, 19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach, Delaware, United States, 19971
- Beebe Health Campus
-
-
District of Columbia
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Washington D.C., District of Columbia, United States, 20037
- George Washington University Medical Center
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-
Florida
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Deerfield Beach, Florida, United States, 33064
- Broward Health North
-
Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
-
Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
-
Lakeland, Florida, United States, 33805
- The Watson Clinic
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
Tampa, Florida, United States, 33607
- Moffitt Cancer Center-International Plaza
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center - McKinley Campus
-
Wesley Chapel, Florida, United States, 33544
- Moffitt Cancer Center at Wesley Chapel
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
-
Decatur, Georgia, United States, 30033
- Atlanta VA Medical Center
-
Savannah, Georgia, United States, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
Valdosta, Georgia, United States, 31602
- South Georgia Medical Center/Pearlman Cancer Center
-
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, United States, 96817
- The Cancer Center of Hawaii-Liliha
-
Honolulu, Hawaii, United States, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
-
Honolulu, Hawaii, United States, 96813
- Queen's Cancer Cenrer - POB I
-
Honolulu, Hawaii, United States, 96813
- Straub Clinic and Hospital
-
Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
-
Honolulu, Hawaii, United States, 96817
- Kuakini Medical Center
-
Honolulu, Hawaii, United States, 96817
- Queen's Cancer Center - Kuakini
-
Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
-
Honolulu, Hawaii, United States, 96819
- Kaiser Permanente Moanalua Medical Center
-
Lihue, Hawaii, United States, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
-
‘Aiea, Hawaii, United States, 96701
- Hawaii Cancer Care - Westridge
-
‘Aiea, Hawaii, United States, 96701
- Pali Momi Medical Center
-
‘Aiea, Hawaii, United States, 96701
- Queen's Cancer Center - Pearlridge
-
‘Aiea, Hawaii, United States, 96701
- The Cancer Center of Hawaii-Pali Momi
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise, Idaho, United States, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, United States, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene, Idaho, United States, 83814
- Kootenai Health - Coeur d'Alene
-
Emmett, Idaho, United States, 83617
- Walter Knox Memorial Hospital
-
Fruitland, Idaho, United States, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, United States, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, United States, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, United States, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa, Idaho, United States, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, United States, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, United States, 83864
- Kootenai Clinic Cancer Services - Sandpoint
-
Twin Falls, Idaho, United States, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Alton, Illinois, United States, 62002
- OSF Saint Anthony's Health Center
-
Aurora, Illinois, United States, 60504
- Rush-Copley Medical Center
-
Barrington, Illinois, United States, 60010
- Advocate Good Shepherd Hospital
-
Bloomington, Illinois, United States, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, United States, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, United States, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, United States, 62918
- SIH Cancer Institute
-
Carthage, Illinois, United States, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, United States, 62801
- Centralia Oncology Clinic
-
Centralia, Illinois, United States, 62801
- Saint Mary's Hospital
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
Chicago, Illinois, United States, 60612
- University of Illinois
-
Chicago, Illinois, United States, 60612
- John H Stroger Jr Hospital of Cook County
-
Chicago, Illinois, United States, 60657
- Advocate Illinois Masonic Medical Center
-
Crystal Lake, Illinois, United States, 60014
- AMG Crystal Lake - Oncology
-
Danville, Illinois, United States, 61832
- Carle at The Riverfront
-
Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, United States, 61021
- Illinois CancerCare-Dixon
-
Downers Grove, Illinois, United States, 60515
- Advocate Good Samaritan Hospital
-
Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, United States, 62401
- Carle Physician Group-Effingham
-
Elgin, Illinois, United States, 60123
- Advocate Sherman Hospital
-
Eureka, Illinois, United States, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, United States, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, United States, 61401
- Illinois CancerCare-Galesburg
-
Hazel Crest, Illinois, United States, 60429
- Advocate South Suburban Hospital
-
Hinsdale, Illinois, United States, 60521
- UChicago Medicine AdventHealth Cancer Institute Hinsdale
-
Kewanee, Illinois, United States, 61443
- Illinois CancerCare-Kewanee Clinic
-
Lake Forest, Illinois, United States, 60045
- Northwestern Medicine Lake Forest Hospital
-
Libertyville, Illinois, United States, 60048
- Condell Memorial Hospital
-
Libertyville, Illinois, United States, 60048
- AMG Libertyville - Oncology
-
Macomb, Illinois, United States, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, United States, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, United States, 62864
- SSM Health Good Samaritan
-
O'Fallon, Illinois, United States, 62269
- Cancer Care Center of O'Fallon
-
O'Fallon, Illinois, United States, 62269
- HSHS Saint Elizabeth's Hospital
-
Oak Lawn, Illinois, United States, 60453-2699
- Advocate Christ Medical Center
-
Ottawa, Illinois, United States, 61350
- Illinois CancerCare-Ottawa Clinic
-
Palos Heights, Illinois, United States, 60463
- Advocate High Tech Medical Park
-
Park Ridge, Illinois, United States, 60068
- Advocate Lutheran General Hospital
-
Pekin, Illinois, United States, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, United States, 61554
- OSF Saint Francis Radiation Oncology at Pekin
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, United States, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, United States, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, United States, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, United States, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, United States, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, United States, 62702
- Springfield Clinic
-
Springfield, Illinois, United States, 62781
- Springfield Memorial Hospital
-
Swansea, Illinois, United States, 62226
- Southwest Illinois Health Services LLP
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center
-
Urbana, Illinois, United States, 61801
- The Carle Foundation Hospital
-
Washington, Illinois, United States, 61571
- Illinois CancerCare - Washington
-
Yorkville, Illinois, United States, 60560
- Rush-Copley Healthcare Center
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46845
- Parkview Regional Medical Center
-
Indianapolis, Indiana, United States, 46237
- Franciscan Health Indianapolis
-
Indianapolis, Indiana, United States, 46219
- Community Cancer Center East
-
Indianapolis, Indiana, United States, 46227
- Community Cancer Center South
-
Indianapolis, Indiana, United States, 46256
- Community Cancer Center North
-
Kokomo, Indiana, United States, 46904
- Community Howard Regional Health
-
Michigan City, Indiana, United States, 46360
- Woodland Cancer Care Center
-
Mooresville, Indiana, United States, 46158
- Franciscan Health Mooresville
-
Terre Haute, Indiana, United States, 47804
- Union Hospital
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, United States, 50010
- McFarland Clinic - Ames
-
Ankeny, Iowa, United States, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
-
Boone, Iowa, United States, 50036
- McFarland Clinic - Boone
-
Carroll, Iowa, United States, 51401
- Saint Anthony Regional Hospital
-
Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, United States, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Council Bluffs, Iowa, United States, 51503
- Alegent Health Mercy Hospital
-
Creston, Iowa, United States, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, United States, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge, Iowa, United States, 50501
- McFarland Clinic - Trinity Cancer Center
-
Fort Dodge, Iowa, United States, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
-
Jefferson, Iowa, United States, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, United States, 50158
- McFarland Clinic - Marshalltown
-
West Des Moines, Iowa, United States, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Garden City, Kansas, United States, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, United States, 67530
- Central Care Cancer Center - Great Bend
-
-
Kentucky
-
Bardstown, Kentucky, United States, 40004
- Flaget Memorial Hospital
-
Corbin, Kentucky, United States, 40701
- Commonwealth Cancer Center-Corbin
-
Lexington, Kentucky, United States, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, United States, 40509
- Saint Joseph Hospital East
-
Lexington, Kentucky, United States, 40504
- Saint Joseph Hospital
-
London, Kentucky, United States, 40741
- Saint Joseph London
-
Louisville, Kentucky, United States, 40202
- The James Graham Brown Cancer Center at University of Louisville
-
Louisville, Kentucky, United States, 40202
- Jewish Hospital
-
Louisville, Kentucky, United States, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, United States, 40215
- Saints Mary and Elizabeth Hospital
-
Shepherdsville, Kentucky, United States, 40165
- Jewish Hospital Medical Center South
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70805
- LSU Health Baton Rouge-North Clinic
-
Baton Rouge, Louisiana, United States, 70809
- Louisiana Hematology Oncology Associates LLC
-
Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
-
Baton Rouge, Louisiana, United States, 70808
- Our Lady of The Lake
-
Baton Rouge, Louisiana, United States, 70808
- Our Lady of the Lake Physician Group
-
New Orleans, Louisiana, United States, 70112
- University Medical Center New Orleans
-
New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Science Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center
-
Baltimore, Maryland, United States, 21201
- University of Maryland/Greenebaum Cancer Center
-
Bel Air, Maryland, United States, 21014
- UM Upper Chesapeake Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
Lowell, Massachusetts, United States, 01854
- Lowell General Hospital
-
Springfield, Massachusetts, United States, 01104
- Mercy Medical Center
-
Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center - University Campus
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Bay City, Michigan, United States, 48706
- McLaren Cancer Institute-Bay City
-
Brighton, Michigan, United States, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brighton, Michigan, United States, 48114
- Trinity Health Medical Center - Brighton
-
Canton, Michigan, United States, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Canton, Michigan, United States, 48188
- Trinity Health Medical Center - Canton
-
Caro, Michigan, United States, 48723
- Caro Cancer Center
-
Chelsea, Michigan, United States, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Chelsea, Michigan, United States, 48118
- Chelsea Hospital
-
Clarkston, Michigan, United States, 48346
- McLaren Cancer Institute-Clarkston
-
Clarkston, Michigan, United States, 48346
- Hematology Oncology Consultants-Clarkston
-
Clarkston, Michigan, United States, 48346
- Newland Medical Associates-Clarkston
-
Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48236
- Henry Ford Health Saint John Hospital
-
East China Township, Michigan, United States, 48054
- Henry Ford River District Hospital
-
Farmington Hills, Michigan, United States, 48334
- Weisberg Cancer Treatment Center
-
Flint, Michigan, United States, 48532
- McLaren Cancer Institute-Flint
-
Flint, Michigan, United States, 48532
- Singh and Arora Hematology Oncology PC
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
-
Flint, Michigan, United States, 48503
- Cancer Hematology Centers - Flint
-
Grand Rapids, Michigan, United States, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, United States, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids, Michigan, United States, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Grosse Pointe Woods, Michigan, United States, 48236
- Henry Ford Saint John Hospital - Academic
-
Grosse Pointe Woods, Michigan, United States, 48236
- Henry Ford Saint John Hospital - Breast
-
Grosse Pointe Woods, Michigan, United States, 48236
- Henry Ford Saint John Hospital - Van Elslander
-
Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, United States, 49009
- Beacon Kalamazoo Cancer Center
-
Kalamazoo, Michigan, United States, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, United States, 48912
- Mid-Michigan Physicians-Lansing
-
Lansing, Michigan, United States, 48910
- Karmanos Cancer Institute at McLaren Greater Lansing
-
Lansing, Michigan, United States, 48912
- University of Michigan Health - Sparrow Lansing
-
Lapeer, Michigan, United States, 48446
- McLaren Cancer Institute-Lapeer Region
-
Livonia, Michigan, United States, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Livonia, Michigan, United States, 48154
- Hope Cancer Clinic
-
Macomb, Michigan, United States, 48044
- Henry Ford Warren Hospital - Breast Macomb
-
Macomb, Michigan, United States, 48044
- Henry Ford Saint John Hospital - Macomb Medical
-
Marlette, Michigan, United States, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Mount Clemens, Michigan, United States, 48043
- McLaren Cancer Institute-Macomb
-
Mount Pleasant, Michigan, United States, 48858
- McLaren Cancer Institute-Central Michigan
-
Muskegon, Michigan, United States, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, United States, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores, Michigan, United States, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Petoskey, Michigan, United States, 49770
- McLaren Cancer Institute-Northern Michigan
-
Pontiac, Michigan, United States, 48341
- Hope Cancer Center
-
Pontiac, Michigan, United States, 48341
- Newland Medical Associates-Pontiac
-
Pontiac, Michigan, United States, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Pontiac, Michigan, United States, 48341
- Michigan Healthcare Professionals Pontiac
-
Port Huron, Michigan, United States, 48060
- McLaren-Port Huron
-
Reed City, Michigan, United States, 49677
- Corewell Health Reed City Hospital
-
Rochester Hills, Michigan, United States, 48309
- Henry Ford Rochester Hospital
-
Saginaw, Michigan, United States, 48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Saginaw, Michigan, United States, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, United States, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, United States, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Sterling Heights, Michigan, United States, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Tawas City, Michigan, United States, 48764
- MyMichigan Medical Center Tawas
-
Traverse City, Michigan, United States, 49684
- Munson Medical Center
-
Warren, Michigan, United States, 48088
- Advanced Breast Care Center PLLC
-
Warren, Michigan, United States, 48093
- Macomb Hematology Oncology PC
-
Warren, Michigan, United States, 48093
- Henry Ford Madison Heights Hospital - Breast
-
Warren, Michigan, United States, 48093
- Henry Ford Health Warren Hospital
-
Warren, Michigan, United States, 48093
- Henry Ford Warren Hospital - GLCMS
-
West Branch, Michigan, United States, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Wyoming, Michigan, United States, 49519
- University of Michigan Health - West
-
Ypsilanti, Michigan, United States, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, United States, 48106
- Huron Gastroenterology PC
-
-
Minnesota
-
Bemidji, Minnesota, United States, 56601
- Sanford Joe Lueken Cancer Center
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, United States, 55337
- Minnesota Oncology - Burnsville
-
Cambridge, Minnesota, United States, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
-
Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, United States, 55432
- Unity Hospital
-
Maple Grove, Minnesota, United States, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55454
- Health Partners Inc
-
Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Medical Center
-
Monticello, Minnesota, United States, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, United States, 56073
- New Ulm Medical Center
-
Princeton, Minnesota, United States, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, United States, 55101
- Regions Hospital
-
Saint Paul, Minnesota, United States, 55102
- United Hospital
-
Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, United States, 55082
- Lakeview Hospital
-
Thief River Falls, Minnesota, United States, 56701
- Sanford Thief River Falls Medical Center
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Worthington, Minnesota, United States, 56187
- Sanford Cancer Center Worthington
-
Wyoming, Minnesota, United States, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Ballwin, Missouri, United States, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, United States, 65613
- Central Care Cancer Center - Bolivar
-
Bonne Terre, Missouri, United States, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, United States, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, United States, 63703
- Mercy Cancer Center - Cape Girardeau
-
Jefferson City, Missouri, United States, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, United States, 64804
- Freeman Health System
-
Joplin, Missouri, United States, 64804
- Mercy Hospital Joplin
-
Rolla, Missouri, United States, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, United States, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, United States, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, United States, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, United States, 63128
- Mercy Hospital South
-
Sullivan, Missouri, United States, 63080
- Missouri Baptist Sullivan Hospital
-
Sunset Hills, Missouri, United States, 63127
- BJC Outpatient Center at Sunset Hills
-
Washington, Missouri, United States, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, United States, 59711
- Community Hospital of Anaconda
-
Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, United States, 59101
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, United States, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, United States, 59405
- Great Falls Clinic
-
Great Falls, Montana, United States, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, United States, 59901
- Logan Health Medical Center
-
Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, United States, 59804
- Community Medical Center
-
-
Nebraska
-
Bellevue, Nebraska, United States, 68123
- Nebraska Medicine-Bellevue
-
Grand Island, Nebraska, United States, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, United States, 68847
- CHI Health Good Samaritan
-
Lincoln, Nebraska, United States, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, United States, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, United States, 68118
- Nebraska Medicine-Village Pointe
-
Omaha, Nebraska, United States, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, United States, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
-
Papillion, Nebraska, United States, 68046
- Midlands Community Hospital
-
-
Nevada
-
Carson City, Nevada, United States, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, United States, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, United States, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, United States, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, United States, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, United States, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, United States, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, United States, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, United States, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, United States, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, United States, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, United States, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, United States, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, United States, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, United States, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, United States, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, United States, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, United States, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, United States, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, United States, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, United States, 89102
- Desert West Surgery
-
Las Vegas, Nevada, United States, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, United States, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, United States, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89169
- University Cancer Center
-
Las Vegas, Nevada, United States, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, United States, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, United States, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, United States, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, United States, 89502
- Renown Regional Medical Center
-
Reno, Nevada, United States, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, United States, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Cape May Court House, New Jersey, United States, 08210
- AtlantiCare Health Park-Cape May Court House
-
Egg Harbor, New Jersey, United States, 08234
- AtlantiCare Surgery Center
-
Hamilton, New Jersey, United States, 08690
- The Cancer Institute of New Jersey Hamilton
-
Jersey City, New Jersey, United States, 07302
- Jersey City Medical Center
-
Livingston, New Jersey, United States, 07039
- Saint Barnabas Medical Center
-
Moorestown, New Jersey, United States, 08057
- Virtua Samson Cancer Center
-
Morristown, New Jersey, United States, 07960
- Morristown Medical Center
-
Mount Holly, New Jersey, United States, 08060
- Virtua Memorial
-
New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, United States, 07101
- Rutgers New Jersey Medical School
-
Summit, New Jersey, United States, 07902
- Overlook Hospital
-
Voorhees Township, New Jersey, United States, 08043
- Virtua Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- University of New Mexico Cancer Center
-
-
New York
-
Brooklyn, New York, United States, 11215
- New York-Presbyterian/Brooklyn Methodist Hospital
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
New York, New York, United States, 10065
- NYP/Weill Cornell Medical Center
-
Rochester, New York, United States, 14642
- University of Rochester
-
Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
-
Syracuse, New York, United States, 13215
- SUNY Upstate Medical Center-Community Campus
-
The Bronx, New York, United States, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, United States, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, United States, 10461
- Montefiore Medical Center-Weiler Hospital
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- AdventHealth Infusion Center Asheville
-
Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
-
Clyde, North Carolina, United States, 28721
- AdventHealth Infusion Center Haywood
-
Gastonia, North Carolina, United States, 28054
- CaroMont Regional Medical Center
-
Greenville, North Carolina, United States, 27834
- East Carolina University
-
Hendersonville, North Carolina, United States, 28792
- AdventHealth Hendersonville
-
Huntersville, North Carolina, United States, 28078
- Novant Health Cancer Institute - Huntersville
-
Huntersville, North Carolina, United States, 28078
- Novant Health Presbyterian Medical Center Huntersville
-
Kernersville, North Carolina, United States, 27284
- Novant Health Cancer Institute - Kernersville
-
Matthews, North Carolina, United States, 28105
- Novant Health Cancer Institute - Matthews
-
Mooresville, North Carolina, United States, 28117
- Novant Health Cancer Institute - Mooresville
-
Mount Airy, North Carolina, United States, 27030
- Novant Health Cancer Institute - Mount Airy
-
New Bern, North Carolina, United States, 28561
- CarolinaEast Medical Center
-
North Wilkesboro, North Carolina, United States, 28659
- Novant Health Cancer Institute - Wilkesboro
-
Statesville, North Carolina, United States, 28625
- Novant Health Cancer Institute - Statesville
-
Thomasville, North Carolina, United States, 27360
- Novant Health Cancer Institute - Thomasville
-
Weaverville, North Carolina, United States, 28787
- AdventHealth Infusion Center Weaverville
-
Winston-Salem, North Carolina, United States, 27103
- Novant Health Forsyth Medical Center
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, United States, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, United States, 58122
- Sanford Broadway Medical Center
-
Fargo, North Dakota, United States, 58103
- Sanford South University Medical Center
-
Fargo, North Dakota, United States, 58103
- Southpointe-Sanford Medical Center Fargo
-
Fargo, North Dakota, United States, 58104
- Sanford Medical Center Fargo
-
-
Ohio
-
Akron, Ohio, United States, 44304
- Summa Health System - Akron Campus
-
Avon, Ohio, United States, 44011
- UH Seidman Cancer Center at UH Avon Health Center
-
Barberton, Ohio, United States, 44203
- Summa Health System - Barberton Campus
-
Beachwood, Ohio, United States, 44122
- UHHS-Chagrin Highlands Medical Center
-
Canton, Ohio, United States, 44708
- Cleveland Clinic Mercy Hospital
-
Centerville, Ohio, United States, 45459
- Miami Valley Hospital South
-
Chardon, Ohio, United States, 44024
- Geauga Hospital
-
Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, United States, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, United States, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, United States, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, United States, 45409
- Premier Blood and Cancer Center
-
Elyria, Ohio, United States, 44035
- Mercy Cancer Center-Elyria
-
Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, United States, 45331
- Miami Valley Cancer Care and Infusion
-
Mansfield, Ohio, United States, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, United States, 44124
- Hillcrest Hospital Cancer Center
-
Medina, Ohio, United States, 44256
- Summa Health Medina Medical Center
-
Mentor, Ohio, United States, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Middleburg Heights, Ohio, United States, 44130
- UH Seidman Cancer Center at Southwest General Hospital
-
Parma, Ohio, United States, 44129
- University Hospitals Parma Medical Center
-
Ravenna, Ohio, United States, 44266
- University Hospitals Portage Medical Center
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care
-
Strongsville, Ohio, United States, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Troy, Ohio, United States, 45373
- Upper Valley Medical Center
-
Westlake, Ohio, United States, 44145
- UH Seidman Cancer Center at Saint John Medical Center
-
Westlake, Ohio, United States, 44145
- UHHS-Westlake Medical Center
-
-
Oklahoma
-
Lawton, Oklahoma, United States, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, United States, 73120
- Mercy Hospital Oklahoma City
-
Tulsa, Oklahoma, United States, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Baker City, Oregon, United States, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, United States, 97701
- Saint Charles Health System
-
Clackamas, Oregon, United States, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, United States, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, United States, 97420
- Bay Area Hospital
-
Newberg, Oregon, United States, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, United States, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City, Oregon, United States, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, United States, 97213
- Providence Portland Medical Center
-
Portland, Oregon, United States, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, United States, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, United States, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Chadds Ford, Pennsylvania, United States, 19317
- Christiana Care Health System-Concord Health Center
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
East Stroudsburg, Pennsylvania, United States, 18301
- Pocono Medical Center
-
Erie, Pennsylvania, United States, 16505
- UPMC Hillman Cancer Center Erie
-
Farrell, Pennsylvania, United States, 16121
- UPMC Cancer Center at UPMC Horizon
-
Hazleton, Pennsylvania, United States, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hazleton, Pennsylvania, United States, 18201
- Lehigh Valley Hospital-Hazleton
-
Hershey, Pennsylvania, United States, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Lewisburg, Pennsylvania, United States, 17837
- Geisinger Medical Oncology-Lewisburg
-
Lewistown, Pennsylvania, United States, 17044
- Lewistown Hospital
-
Monroeville, Pennsylvania, United States, 15146
- UPMC Hillman Cancer Center - Monroeville
-
Monroeville, Pennsylvania, United States, 15146
- UPMC Cancer Center - Monroeville
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, United States, 19114
- Jefferson Torresdale Hospital
-
Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
Pittsburgh, Pennsylvania, United States, 15232
- UPMC-Shadyside Hospital
-
Pittsburgh, Pennsylvania, United States, 15237
- UPMC-Passavant Hospital
-
Pittsburgh, Pennsylvania, United States, 15243
- UPMC-Saint Clair Hospital Cancer Center
-
Pottsville, Pennsylvania, United States, 17901
- Geisinger Cancer Services-Pottsville
-
Scranton, Pennsylvania, United States, 18510
- Community Medical Center
-
West Reading, Pennsylvania, United States, 19611
- Reading Hospital
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Willow Grove, Pennsylvania, United States, 19090
- Asplundh Cancer Pavilion
-
-
South Carolina
-
Boiling Springs, South Carolina, United States, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
Easley, South Carolina, United States, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, United States, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, United States, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, United States, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, United States, 29601
- Saint Francis Hospital
-
Greer, South Carolina, United States, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, United States, 29651
- Gibbs Cancer Center-Pelham
-
Seneca, South Carolina, United States, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
-
Union, South Carolina, United States, 29379
- SMC Center for Hematology Oncology Union
-
-
South Dakota
-
Aberdeen, South Dakota, United States, 57401
- Avera Cancer Institute-Aberdeen
-
Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, United States, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, United States, 79106
- The Don and Sybil Harrington Cancer Center
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
Austin, Texas, United States, 78701
- Dell Seton Medical Center at The University of Texas
-
Bryan, Texas, United States, 77802
- Saint Joseph Regional Cancer Center
-
Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Houston, Texas, United States, 77030
- Memorial Hermann Texas Medical Center
-
Humble, Texas, United States, 77338
- Memorial Hermann Northeast Hospital
-
-
Utah
-
American Fork, Utah, United States, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, United States, 84720
- Sandra L Maxwell Cancer Center
-
Logan, Utah, United States, 84321
- Logan Regional Hospital
-
Murray, Utah, United States, 84107
- Intermountain Medical Center
-
Ogden, Utah, United States, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, United States, 84604
- Utah Valley Regional Medical Center
-
Riverton, Utah, United States, 84065
- Riverton Hospital
-
Salt Lake City, Utah, United States, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, United States, 84143
- LDS Hospital
-
St. George, Utah, United States, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Saint Johnsbury, Vermont, United States, 05819
- Dartmouth Cancer Center - North
-
-
Virginia
-
Richmond, Virginia, United States, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, United States, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Aberdeen, Washington, United States, 98520
- Providence Regional Cancer System-Aberdeen
-
Auburn, Washington, United States, 98001
- MultiCare Auburn Medical Center
-
Bellevue, Washington, United States, 98004
- Overlake Medical Center
-
Bellingham, Washington, United States, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, United States, 98166
- Highline Medical Center-Main Campus
-
Centralia, Washington, United States, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, United States, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, United States, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, United States, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, United States, 98003
- Saint Francis Hospital
-
Gig Harbor, Washington, United States, 98335
- MultiCare Gig Harbor Medical Park
-
Issaquah, Washington, United States, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, United States, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, United States, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, United States, 98499
- Saint Clare Hospital
-
Longview, Washington, United States, 98632
- PeaceHealth Saint John Medical Center
-
Mount Vernon, Washington, United States, 98274
- Skagit Regional Health Cancer Care Center
-
Port Townsend, Washington, United States, 98368
- Jefferson Healthcare
-
Poulsbo, Washington, United States, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Puyallup, Washington, United States, 98372
- MultiCare Good Samaritan Hospital
-
Renton, Washington, United States, 98055
- Valley Medical Center
-
Seattle, Washington, United States, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, United States, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, United States, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, United States, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, United States, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, United States, 98584
- Providence Regional Cancer System-Shelton
-
Silverdale, Washington, United States, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Spokane, Washington, United States, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, United States, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, United States, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, United States, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, United States, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, United States, 98405
- MultiCare Tacoma General Hospital
-
Tacoma, Washington, United States, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, United States, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, United States, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, United States, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, United States, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Appleton, Wisconsin, United States, 54911
- ThedaCare Regional Cancer Center
-
Burlington, Wisconsin, United States, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Eau Claire, Wisconsin, United States, 54701
- Marshfield Medical Center-EC Cancer Center
-
Eau Claire, Wisconsin, United States, 54701
- HSHS Sacred Heart Hospital
-
Germantown, Wisconsin, United States, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, United States, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, United States, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, United States, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Kenosha, Wisconsin, United States, 53142
- Aurora Cancer Care-Kenosha South
-
La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
-
Manitowoc, Wisconsin, United States, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, United States, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, United States, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, United States, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, United States, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, United States, 53233
- Aurora Sinai Medical Center
-
Minocqua, Wisconsin, United States, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, United States, 53149
- ProHealth D N Greenwald Center
-
New Richmond, Wisconsin, United States, 54017
- Cancer Center of Western Wisconsin
-
Oak Creek, Wisconsin, United States, 53154
- Drexel Town Square Health Center
-
Oconomowoc, Wisconsin, United States, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, United States, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, United States, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, United States, 53406
- Aurora Cancer Care-Racine
-
Rice Lake, Wisconsin, United States, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, United States, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sheboygan, Wisconsin, United States, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, United States, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Sturgeon Bay, Wisconsin, United States, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, United States, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, United States, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, United States, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, United States, 53188
- ProHealth Waukesha Memorial Hospital
-
Wauwatosa, Wisconsin, United States, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, United States, 53227
- Aurora West Allis Medical Center
-
West Bend, Wisconsin, United States, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Weston, Wisconsin, United States, 54476
- Marshfield Medical Center - Weston
-
-
Wyoming
-
Cheyenne, Wyoming, United States, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, United States, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- STEP 1: Age >= 18 years
- STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- STEP 1: Patients must have oropharynx cancer (American Joint Committee on Cancer [AJCC] 8) that is p16-positive by immunohistochemistry OR p16 equivocal by IHC and HPV positive by in situ hybridization with the following criteria: >= 10 pack-years, stage T1-2N2-N3 or T3-4N0-3 (less than 10 pack-years is considered a non-smoker) OR < 10 pack-years, stage T4N0-N3 or T1-3N2-3
- STEP 1: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.
- STEP 1: Patients with a history of allergic reactions attributed to platinum-based chemotherapy agents are excluded.
STEP 1: Patients must not have had prior systemic therapy, radiation treatment or surgery for p16 positive oropharyngeal squamous cell carcinoma (OPSCC).
- NOTE: Patients who had resection of T1 or T2 carcinoma with no radiation or chemotherapy are eligible if surgery was done 5 years prior to enrollment
- STEP 1: Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors.
- STEP 1: Patients must not receive investigational agents within 4 weeks of enrollment or at any time while on study.
- STEP 1: Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded.
- STEP 1: Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded.
- STEP 1: Patients with a history of prior or second malignancy are excluded, with the exception of curatively treated non-melanoma skin cancer, or curatively treated cervical cancer; additionally, patients curatively treated for malignancy who remain disease-free at > 2 years of follow up, are not excluded.
- STEP 1: Absolute neutrophil count (ANC) >= 1500/mm^3 (must be obtained =< 2 weeks prior to randomization).
- STEP 1: Hemoglobin (Hgb) >= 8.0 g/dL (must be obtained =< 2 weeks prior to randomization).
- STEP 1: Platelet count >= 100,000/mm^3 (must be obtained =< 2 weeks prior to randomization).
- STEP 1: Creatinine clearance of >= 60 ml/min (must be obtained =< 2 weeks prior to randomization). Creatinine clearance may be measured or calculated. If calculating, creatinine clearance, use the Cockcroft-Gault formula.
- STEP 1: Total bilirubin within 1.5 times the normal limits (must be obtained =< 2 weeks prior to randomization).
- STEP 1: Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) within 2.0 times the normal limits (must be obtained =< 2 weeks prior to randomization).
- STEP 1: Alkaline phosphatase within 2.0 times the normal limits (must be obtained =< 2 weeks prior to randomization).
- STEP 1: Patients must not be pregnant or breast-feeding as chemotherapy, radiation, and immunotherapy may have possible teratogenicity effects; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A patient of childbearing potential is any patient, regardless of 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 (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- STEP 1: Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period.
- STEP 1: Patients must have measurable disease
- STEP 1: Patients must have tumor measurements with CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) within 4 weeks prior to Step 1 randomization.
- STEP 1: 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, should 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 should 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 should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
- STEP 1: 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: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications which are expected to continue during nivolumab 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: Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- STEP 1: 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 antiviral regimen
- STEP 1: Patients must not be receiving any other investigational agents.
- STEP 1: Patient must not have a baseline clinically significant hearing loss, which in the opinion of the investigator would preclude the use of cisplatin
- STEP 2: Patients must have progression per RECIST criteria AND tissue-proven progression on Arm B treatment within 12 months after completion of radiation therapy.
- STEP 2: ECOG performance status of 0 or 1.
- STEP 2: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.
- STEP 2: Patients must not have received non-protocol anti-cancer therapy after completion of radiation and chemotherapy.
- STEP 2: ANC >= 1500/mm^3 (must be obtained =< 2 weeks prior to registration).
- STEP 2: Hgb >= 8.0 g/dL (must be obtained =< 2 weeks prior to registration).
- STEP 2: Platelet count >= 100,000/mm^3 (must be obtained =< 2 weeks prior to registration).
- STEP 2: Creatinine within institutional limits of normal (must be obtained =< 2 weeks prior to registration)
- STEP 2: Total bilirubin within 1.5 times the normal limits (must be obtained =< 2 weeks prior to registration).
- STEP 2: SGOT (AST) or SGPT (ALT) within 2.0 times the normal limits (must be obtained =< 2 weeks prior to registration).
- STEP 2: Alkaline phosphatase within 1.5 times the normal limits (must be obtained =< 2 weeks prior to registration).
- STEP 2: Patients must not be pregnant or breast-feeding as chemotherapy, radiation, and immunotherapy may have possible teratogenicity effects; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A patient of childbearing potential is any patient, regardless of 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 (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- STEP 2: Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period.
STEP 2: Patients must have measurable disease at the time of documented progression
- NOTE: For patients that have undergone salvage surgery for disease recurrence, measurable disease is not required at the time of registration to Step 2
STEP 2: Patients must have tumor measurements with CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) within 4 weeks prior to Step 2 registration
- NOTE: Patients that have undergone salvage surgery for disease recurrence prior to Step 2 are not required to have measurable disease post-resection, but must have CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) after salvage surgery and within 4 weeks prior to step 2 registration to establish a baseline prior to nivolumab
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A (cisplatin, IMRT, nivolumab)
Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions.
Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
Patients undergo CT or FDG PET/CT scans throughout the trial.
Patients may undergo ECHO as clinically indicated.
Additionally, patients undergo blood sample collection during screening.
|
Given IV
Other Names:
Given IV
Other Names:
Undergo blood sample collection
Other Names:
Undergo IMRT
Other Names:
Undergo PET/CT
Other Names:
Undergo CT or PET/CT
Other Names:
Receive FDG
Other Names:
Undergo ECHO
Other Names:
|
|
Active Comparator: Arm B (cisplatin, IMRT, observation)
Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation. Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening. |
Given IV
Other Names:
Undergo blood sample collection
Other Names:
Undergo IMRT
Other Names:
Undergo observation
Other Names:
Undergo PET/CT
Other Names:
Undergo CT or PET/CT
Other Names:
Receive FDG
Other Names:
Undergo ECHO
Other Names:
|
|
Experimental: Arm C (nivolumab)
Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
Patients undergo CT or FDG PET/CT scans throughout the trial.
Patients may undergo ECHO as clinically indicated.
Additionally, patients undergo blood sample collection during screening.
|
Given IV
Other Names:
Undergo blood sample collection
Other Names:
Undergo PET/CT
Other Names:
Undergo CT or PET/CT
Other Names:
Receive FDG
Other Names:
Undergo ECHO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: From randomization to death, assessed up to 10 years
|
Log rank test will be used to compare OS.
As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et.
al, 2000) will also be considered.
Kaplan-Meier method and Cox regression will be used for the survival outcome analyses.
|
From randomization to death, assessed up to 10 years
|
|
Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT
Time Frame: At 12 weeks post therapy
|
Logrank tests and input hazard rates will be used.
|
At 12 weeks post therapy
|
|
Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT
Time Frame: At 12 weeks post therapy
|
Logrank tests and input hazard rates will be used.
|
At 12 weeks post therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years
|
Progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
The comparison of PFS will use stratified log rank test and will be intent-to-treat analyses.
|
From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years
|
|
Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS
Time Frame: Baseline up to 10 years
|
Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
|
Baseline up to 10 years
|
|
Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS
Time Frame: Baseline up to 10 years
|
Saliva and plasma HPV status at 12 weeks and 9 months following completion of concurrent therapy will also be analyzed regarding effect on outcome.
Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
|
Baseline up to 10 years
|
|
Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS
Time Frame: Baseline up to 10 years
|
Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
|
Baseline up to 10 years
|
|
Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS
Time Frame: Baseline up to 10 years
|
Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
|
Baseline up to 10 years
|
|
SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative)
Time Frame: Baseline up to 10 years
|
Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
|
Baseline up to 10 years
|
|
Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA)
Time Frame: Up to 9 months post-therapy
|
Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses.
|
Up to 9 months post-therapy
|
|
PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks
Time Frame: At 12 weeks post chemoradiation therapy
|
Kappa statistics will be applied to evaluate the agreement between PET based therapy response assessment (Hopkins criteria) and RECIST 1.1 assessment at 12 weeks post chemoradiation therapy.
|
At 12 weeks post chemoradiation therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nabil F Saba, ECOG-ACRIN Cancer Research Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Neoplasms by Site
- Neoplasms
- Head and Neck Neoplasms
- Otorhinolaryngologic Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Pharyngeal Diseases
- Oropharyngeal Neoplasms
- Health Services Administration
- Amino Acids, Peptides, and Proteins
- Proteins
- Investigative Techniques
- Methods
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Quality of Health Care
- Carbohydrates
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Inorganic Chemicals
- Chlorine Compounds
- Nitrogen Compounds
- Elements
- Metals
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Metals, Heavy
- Platinum Compounds
- Radiotherapy
- Deoxyglucose
- Deoxy Sugars
- Outcome Assessment, Health Care
- Outcome and Process Assessment, Health Care
- Transition Elements
- Radiotherapy, Conformal
- Radiotherapy, Computer-Assisted
- Nivolumab
- Fluorodeoxyglucose F18
- Cisplatin
- 1,2-diaminocyclohexaneplatinum II citrate
- Observation
- Specimen Handling
- Magnetic Resonance Spectroscopy
- Watchful Waiting
- Platinum
- Radiotherapy, Intensity-Modulated
Other Study ID Numbers
- NCI-2019-00179 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180820 (U.S. NIH Grant/Contract)
- EA3161 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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Jonathan Schoenfeld, MD, MPHNaverisRecruitingHPV Positive Oropharyngeal Squamous Cell Carcinoma | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC... and other conditionsUnited States
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Jonsson Comprehensive Cancer CenterAstraZenecaTerminatedOropharyngeal Squamous Cell Carcinoma | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic... and other conditionsUnited States
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Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma... and other conditionsUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage I HPV-Mediated (p16-Positive)... and other conditionsUnited States
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Mayo ClinicRecruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma... and other conditionsUnited States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI)Active, not recruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Oropharyngeal Human Papillomavirus-Positive Squamous...United States
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Northwestern UniversityNational Cancer Institute (NCI)RecruitingClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8United States
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NRG OncologyNot yet recruitingHead and Neck Squamous Cell Carcinoma | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Hypopharyngeal Carcinoma AJCC v8 | Stage III Laryngeal Cancer AJCC v8 | Stage III Lip and Oral Cavity Cancer AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma... and other conditions
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Hypopharyngeal Carcinoma AJCC v8 | Stage III Laryngeal Cancer AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Stage IV Hypopharyngeal Carcinoma AJCC v8 | Stage IV Laryngeal Cancer... and other conditionsUnited States
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Jonsson Comprehensive Cancer CenterEli Lilly and CompanyTerminatedClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage IV HPV-Mediated (p16-Positive)... and other conditionsUnited States
Clinical Trials on Nivolumab
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Universitair Ziekenhuis BrusselRecruiting
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Brown UniversityBristol-Myers Squibb; The Miriam Hospital; Rhode Island Hospital; Women and Infants...Terminated
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Baptist Health South FloridaBristol-Myers Squibb; NovoCure Ltd.TerminatedRecurrent GlioblastomaUnited States
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Michael B. Atkins, MDBristol-Myers Squibb; Hoosier Cancer Research NetworkCompletedAdvanced Renal Cell CarcinomaUnited States
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Bristol-Myers SquibbActive, not recruitingMelanomaSpain, Greece, Italy, United States, Chile
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Jennifer ZhangAlligator Bioscience ABRecruitingBreast CancerUnited States
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Bristol-Myers SquibbCompletedLung CancerItaly, United States, France, Russian Federation, Spain, Argentina, Belgium, Brazil, Canada, Chile, Czechia, Germany, Greece, Hungary, Mexico, Netherlands, Poland, Romania, Switzerland, Turkey, United Kingdom
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IRCCS San RaffaeleBristol-Myers SquibbRecruiting
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Guliz OzgunBritish Columbia Cancer AgencyNot yet recruiting
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National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsCompletedHepatocellular Carcinoma (HCC)Taiwan