PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

Who is this study for? Patients with advanced kidney cancer
Status: Active_not_recruiting
Location: See all (864) locations...
Intervention Type: Other, Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• STEP I REGISTRATION CRITERIA

• Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid or rhabdoid features

• Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1

• Measurable disease as defined in the protocol

• Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following): Karnofsky performance status \[KPS\] \< 80, \< 1 year from diagnosis \[including initial nephrectomy\] to systemic treatment for metastatic disease, hemoglobin less than lower limit of normal \[LLN\], corrected calcium concentration greater than upper limit of normal \[ULN\], absolute neutrophil count greater than ULN, platelet count \> ULN)

• Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment

• Karnofsky performance status \>= 70%

• No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as \> 1 year since completion of systemic therapy

• No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 \[\>28 days\]. Prior adjuvant sunitinib \>180 days since completion and prior immunotherapy as above are allowed).

• No systemic cancer therapy less than 28 days prior to registration; no radiation therapy less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy

• Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\< 14 days prior to registration is required

• Age \>= 18 years

• None of the following:

‣ Active autoimmune disease requiring ongoing therapy

⁃ Ongoing acute toxicity \> grade 2 from previous treatment

⁃ History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies

⁃ Active hepatitis B/C, or active tuberculosis (purified protein derivative \[PPD\] response without active tuberculosis \[TB\] is allowed)

⁃ HIV-infected patients with detectable viral load within 6 months prior to registration. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible

⁃ Concurrent use of immunosuppressive medication including prednisone above 10 mg daily

⁃ Uncontrolled adrenal insufficiency

⁃ Uncontrolled hypertension (systolic blood pressure \[BP\] \> 150mmHg or diastolic BP \> 90mmHg)

⁃ Major surgery less than 28 days prior to registration

⁃ Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to registration

⁃ Any arterial thrombotic events within 180 days prior to registration

⁃ Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to registration

⁃ Cavitating pulmonary lesions or known endotracheal or endobronchial disease manifestations

⁃ Lesions encasing or invading any major blood vessels (this does not include tumor thrombus extending into/through renal vein/inferior vena cava \[IVC\]). Patients with tumor thrombus extending into/through renal vein are considered eligible

⁃ Moderate of severe hepatic impairment (child-Pugh B or C)

⁃ Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180 days prior to registration. (Any asymptomatic, treated pulmonary embolism or asymptomatic, treated deep venous thrombosis \> 30 days prior to registration allowed)

⁃ Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms

⁃ Unstable cardiac arrhythmia within 6 months prior to registration

⁃ Any gastrointestinal (GI) bleeding =\< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =\< 90 days prior to registration

⁃ History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration

⁃ Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration

⁃ Untreated hypothyroidism (treated hypothyroidism on thyroid replacement therapy is allowed. Abnormal thyroid-stimulating hormone \[TSH\] is acceptable with normal T3/free T4 if treated on thyroid replacement therapy)

⁃ Evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome

⁃ Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor

⁃ Significant cardiac ischemia events (ST elevation myocardial infarction \[STEMI\] or non-ST-elevation myocardial infarction \[NSTEMI\]) within 6 months or active New York (NY) Heart Association class 3-4 heart failure symptoms

• Absolute neutrophil count (ANC) \>= 1,500/mm\^3

• Platelet count \>= 100,000/mm\^3

• Hemoglobin \>= 8 g/dL

• Calculated (Calc.) creatinine clearance \>= 30 mL/min

• Urine protein =\< 1+ or urine protein to creatinine (UPC) ratio \< 1

• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except for patients with known or likely Gilbert's syndrome, for whom total bilirubin up to 3 mg/dL is allowed with direct bilirubin =\< 20% total bilirubin)

• Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =\< 2.5 x upper limit of normal (ULN) or \< 5 x ULN if hepatic metastases present

• STEP 2 REGISTRATION ELIGIBILITY CRITERIA

• Successful completion of at least 1 cycle of ipilimumab/nivolumab

• Resolution of any treatment-related adverse events to grade 1 or less per dose modification section (this criteria does not include any adverse events \[AEs\] not attributable to treatment which are present due to disease), with prednisone-equivalent dosing at 10 mg daily or less. Exceptions for this criteria include patients receiving replacement hormone treatments (such as levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for adrenal insufficiency). Please contact study chair if further discussion is needed

• No more than 80 days from last dose of ipilimumab/nivolumab

Locations
United States
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Alaska Oncology and Hematology LLC
Anchorage
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Katmai Oncology Group
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Providence Alaska Medical Center
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Fairbanks Memorial Hospital
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Alabama
University of South Alabama Mitchell Cancer Institute
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Arkansas
Highlands Oncology Group - Fayetteville
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Mercy Hospital Fort Smith
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CHI Saint Vincent Cancer Center Hot Springs
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Highlands Oncology Group - Rogers
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Highlands Oncology Group
Springdale
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Kingman Regional Medical Center
Kingman
Cancer Center at Saint Joseph's
Phoenix
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Kaiser Permanente-Anaheim
Anaheim
Mission Hope Medical Oncology - Arroyo Grande
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PCR Oncology
Arroyo Grande
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Kaiser Permanente-Bellflower
Bellflower
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Community Cancer Institute
Clovis
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Clovis
Kaiser Permanente-Fontana
Fontana
Kaiser Permanente South Bay
Harbor City
Kaiser Permanente-Irvine
Irvine
UC San Diego Moores Cancer Center
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Kaiser Permanente Los Angeles Medical Center
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Los Angeles
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Kaiser Permanente - Panorama City
Panorama City
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University of California Davis Comprehensive Cancer Center
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San Diego
UCSF Medical Center-Mission Bay
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Colorado
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UCHealth University of Colorado Hospital
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Colorado Blood Cancer Institute
Denver
Kaiser Permanente-Franklin
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National Jewish Health-Main Campus
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Presbyterian - Saint Lukes Medical Center - Health One
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Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
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Rose Medical Center
Denver
Saint Joseph Hospital - Cancer Centers of Colorado
Denver
The Women's Imaging Center
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UCHealth - Cherry Creek
Denver
Western Surgical Care
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Southwest Oncology PC
Durango
Mountain Blue Cancer Care Center - Swedish
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Rocky Mountain Cancer Centers - Swedish
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Swedish Medical Center
Englewood
The Melanoma and Skin Cancer Institute
Englewood
Cancer Care and Hematology-Fort Collins
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Poudre Valley Hospital
Fort Collins
National Jewish Health-Western Hematology Oncology
Golden
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Grand Junction
Banner North Colorado Medical Center
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Greeley
UCHealth Highlands Ranch Hospital
Highlands Ranch
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette
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Lafayette
Rocky Mountain Cancer Centers-Lakewood
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Littleton Adventist Hospital
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Lone Tree
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Sky Ridge Medical Center
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UCHealth Lone Tree Health Center
Lone Tree
Longmont United Hospital
Longmont
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Longmont
Banner McKee Medical Center
Loveland
Medical Center of the Rockies
Loveland
Parker Adventist Hospital
Parker
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Pueblo
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Thornton
Rocky Mountain Cancer Centers-Thornton
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Intermountain Health Lutheran Hospital
Wheat Ridge
Connecticut
Stamford Hospital/Bennett Cancer Center
Stamford
Washington, D.c.
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Northside Hospital
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Pali Momi Medical Center
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Queen's Cancer Center - Pearlridge
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The Cancer Center of Hawaii-Pali Momi
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Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Mission Cancer and Blood - Ankeny
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McFarland Clinic - Boone
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Saint Anthony Regional Hospital
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Mercy Cancer Center-West Lakes
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Mission Cancer and Blood - West Des Moines
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Alegent Health Mercy Hospital
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Greater Regional Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Fort Dodge
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Fruitland
Idaho Urologic Institute-Meridian
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Illinois CancerCare-Bloomington
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Carbondale
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John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Rush University Medical Center
Chicago
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Carle at The Riverfront
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Cancer Care Specialists of Illinois - Decatur
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Decatur
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Illinois CancerCare-Dixon
Dixon
Carle Physician Group-Effingham
Effingham
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Effingham
Elmhurst Memorial Hospital
Elmhurst
Illinois CancerCare-Eureka
Eureka
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Western Illinois Cancer Treatment Center
Galesburg
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Homer Glen
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Illinois CancerCare-Kewanee Clinic
Kewanee
Northwestern Medicine Lake Forest Hospital
Lake Forest
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Carle Physician Group-Mattoon/Charleston
Mattoon
Loyola University Medical Center
Maywood
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park
SSM Health Good Samaritan
Mount Vernon
Edward Hospital/Cancer Center
Naperville
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Cancer Care Center of O'Fallon
O'fallon
Northwestern Medicine Orland Park
Orland Park
University of Chicago Medicine-Orland Park
Orland Park
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Ottawa
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Pekin
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Peoria
Methodist Medical Center of Illinois
Peoria
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Peru
Valley Radiation Oncology
Peru
Edward Hospital/Cancer Center?Plainfield
Plainfield
Illinois CancerCare-Princeton
Princeton
UW Health Carbone Cancer Center Rockford
Rockford
Memorial Hospital East
Shiloh
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Springfield
Springfield Clinic
Springfield
Springfield Memorial Hospital
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois CancerCare - Washington
Washington
Rush-Copley Healthcare Center
Yorkville
Indiana
Franciscan Health Indianapolis
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Sidney and Lois Eskenazi Hospital
Indianapolis
Woodland Cancer Care Center
Michigan City
Franciscan Health Mooresville
Mooresville
Reid Health
Richmond
Kansas
University of Kansas Clinical Research Center
Fairway
Central Care Cancer Center - Garden City
Garden City
Central Care Cancer Center - Great Bend
Great Bend
HaysMed
Hays
Lawrence Memorial Hospital
Lawrence
Kansas Institute of Medicine Cancer and Blood Center
Lenexa
Minimally Invasive Surgery Hospital
Lenexa
The University of Kansas Cancer Center - Olathe
Olathe
Menorah Medical Center
Overland Park
University of Kansas Cancer Center-Overland Park
Overland Park
Cancer Center of Kansas - Parsons
Parsons
Ascension Via Christi - Pittsburg
Pittsburg
Freeman Physician Group of Pittsburg
Pittsburg
Salina Regional Health Center
Salina
University of Kansas Health System Saint Francis Campus
Topeka
University of Kansas Hospital-Westwood Cancer Center
Westwood
Ascension Via Christi Hospitals Wichita
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Kentucky
Flaget Memorial Hospital
Bardstown
Commonwealth Cancer Center-Corbin
Corbin
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
University of Kentucky/Markey Cancer Center
Lexington
Saint Joseph London
London
Baptist Health Louisville
Louisville
Jewish Hospital
Louisville
Saints Mary and Elizabeth Hospital
Louisville
UofL Health Medical Center Northeast
Louisville
Jewish Hospital Medical Center South
Shepherdsville
Louisiana
Hematology/Oncology Clinic PLLC
Baton Rouge
Louisiana Hematology Oncology Associates LLC
Baton Rouge
LSU Health Baton Rouge-North Clinic
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
Ochsner High Grove
Baton Rouge
Our Lady of The Lake
Baton Rouge
Our Lady of the Lake Physician Group
Baton Rouge
Northshore Oncology Associates-Covington
Covington
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington
Oncology Center of The South Incorporated
Houma
Terrebonne General Medical Center
Houma
East Jefferson General Hospital
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie
Ochsner LSU Health Monroe Medical Center
Monroe
Louisiana State University Health Science Center
New Orleans
Ochsner Medical Center Jefferson
New Orleans
Touro Infirmary
New Orleans
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New Orleans
University Medical Center New Orleans
New Orleans
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Shreveport
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Newton
Mercy Medical Center
Springfield
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Harold Alfond Center for Cancer Care
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Waldo County General Hospital
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Lafayette Family Cancer Center-EMMC
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Sanford
Maine Medical Partners - South Portland
South Portland
Michigan
Hickman Cancer Center
Adrian
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor
Bronson Battle Creek
Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton
Trinity Health Medical Center - Brighton
Brighton
Henry Ford Cancer Institute-Downriver
Brownstown
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton
Trinity Health Medical Center - Canton
Canton
Caro Cancer Center
Caro
Chelsea Hospital
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea
Hematology Oncology Consultants-Clarkston
Clarkston
Newland Medical Associates-Clarkston
Clarkston
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Henry Ford Medical Center-Fairlane
Dearborn
Henry Ford Health Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Henry Ford River District Hospital
East China Township
OSF Saint Francis Hospital and Medical Group
Escanaba
Cancer Hematology Centers - Flint
Flint
Genesee Hematology Oncology PC
Flint
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids
Trinity Health Grand Rapids Hospital
Grand Rapids
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods
Allegiance Health
Jackson
Ascension Borgess Cancer Center
Kalamazoo
Ascension Borgess Hospital
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
University of Michigan Health - Sparrow Lansing
Lansing
Hope Cancer Clinic
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Henry Ford Saint John Hospital - Macomb Medical
Macomb
Henry Ford Warren Hospital - Breast Macomb
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette
Toledo Clinic Cancer Centers-Monroe
Monroe
Trinity Health Muskegon Hospital
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores
Henry Ford Health Providence Novi Hospital
Novi
Henry Ford Medical Center-Columbus
Novi
Hope Cancer Center
Pontiac
Michigan Healthcare Professionals Pontiac
Pontiac
Newland Medical Associates-Pontiac
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac
Huron Medical Center PC
Port Huron
Lake Huron Medical Center
Port Huron
Corewell Health Reed City Hospital
Reed City
Henry Ford Rochester Hospital
Rochester Hills
MyMichigan Medical Center Saginaw
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph
Henry Ford Macomb Health Center - Shelby Township
Shelby
Henry Ford Health Providence Southfield Hospital
Southfield
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights
MyMichigan Medical Center Tawas
Tawas City
Munson Medical Center
Traverse City
Advanced Breast Care Center PLLC
Warren
Henry Ford Health Warren Hospital
Warren
Henry Ford Madison Heights Hospital - Breast
Warren
Henry Ford Warren Hospital - GLCMS
Warren
Macomb Hematology Oncology PC
Warren
Henry Ford West Bloomfield Hospital
West Bloomfield
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
University of Michigan Health - West
Wyoming
Huron Gastroenterology PC
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti
Minnesota
Riverwood Healthcare Center
Aitkin
Sanford Joe Lueken Cancer Center
Bemidji
Essentia Health Saint Joseph's Medical Center
Brainerd
Fairview Ridges Hospital
Burnsville
Minnesota Oncology - Burnsville
Burnsville
Cambridge Medical Center
Cambridge
Mercy Hospital
Coon Rapids
Essentia Health - Deer River Clinic
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes
Essentia Health Cancer Center
Duluth
Essentia Health Saint Mary's Medical Center
Duluth
Miller-Dwan Hospital
Duluth
Fairview Southdale Hospital
Edina
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls
Essentia Health - Fosston
Fosston
Unity Hospital
Fridley
Essentia Health Hibbing Clinic
Hibbing
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
Minneapolis VA Medical Center
Minneapolis
Monticello Cancer Center
Monticello
New Ulm Medical Center
New Ulm
Essentia Health - Park Rapids
Park Rapids
Fairview Northland Medical Center
Princeton
North Memorial Medical Health Center
Robbinsdale
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Essentia Health Sandstone
Sandstone
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Sanford Thief River Falls Medical Center
Thief River Falls
Essentia Health Virginia Clinic
Virginia
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Sanford Cancer Center Worthington
Worthington
Fairview Lakes Medical Center
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Missouri
Saint Louis Cancer and Breast Institute-Ballwin
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Central Care Cancer Center - Bolivar
Bolivar
Parkland Health Center-Bonne Terre
Bonne Terre
Cox Cancer Center Branson
Branson
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Saint Luke's Hospital
Chesterfield
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Parkland Health Center - Farmington
Farmington
Centerpoint Medical Center LLC
Independence
MU Health Care Goldschmidt Cancer Center
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Freeman Health System
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Mercy Hospital Joplin
Joplin
Research Medical Center
Kansas City
University Health Truman Medical Center
Kansas City
University of Kansas Cancer Center - North
Kansas City
University of Kansas Cancer Center - Lee's Summit
Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Heartland Regional Medical Center
Saint Joseph
Mercy Hospital Saint Louis
Saint Louis
Mercy Hospital South
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Siteman Cancer Center at Christian Hospital
Saint Louis
Siteman Cancer Center-South County
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
BJC Outpatient Center at Sunset Hills
Sunset Hills
Mercy Hospital Washington
Washington
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus
Baptist Cancer Center-Grenada
Grenada
Gulfport Memorial Hospital
Gulfport
University of Mississippi Medical Center
Jackson
Baptist Memorial Hospital and Cancer Center-Union County
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Saint Vincent Frontier Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Health Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Logan Health Medical Center
Kalispell
Community Medical Center
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
AdventHealth Infusion Center Asheville
Asheville
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Novant Health Presbyterian Medical Center
Charlotte
Wake Forest University at Clemmons
Clemmons
Southeastern Medical Oncology Center-Clinton
Clinton
AdventHealth Infusion Center Haywood
Clyde
Duke University Medical Center
Durham
Durham VA Medical Center
Durham
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
ECU Health Medical Center
Greenville
AdventHealth Hendersonville
Hendersonville
Margaret R Pardee Memorial Hospital
Hendersonville
Novant Health Cancer Institute - Huntersville
Huntersville
Novant Health Presbyterian Medical Center Huntersville
Huntersville
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
ECU Health Oncology Kenansville
Kenansville
Novant Health Cancer Institute - Kernersville
Kernersville
ECU Health Oncology Kinston
Kinston
Novant Health Cancer Institute - Matthews
Matthews
Novant Health Cancer Institute - Mooresville
Mooresville
Novant Health Cancer Institute - Mount Airy
Mount Airy
Novant Health Cancer Institute - Wilkesboro
North Wilkesboro
ECU Health Oncology Richlands
Richlands
Novant Health Cancer Institute - Statesville
Statesville
Wake Forest Baptist Health - Hematology Oncology - Statesville
Statesville
Novant Health Cancer Institute - Thomasville
Thomasville
AdventHealth Infusion Center Weaverville
Weaverville
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro
Novant Health Forsyth Medical Center
Winston-salem
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Essentia Health Cancer Center-South University Clinic
Fargo
Sanford Broadway Medical Center
Fargo
Sanford Medical Center Fargo
Fargo
Sanford Roger Maris Cancer Center
Fargo
Sanford South University Medical Center
Fargo
Southpointe-Sanford Medical Center Fargo
Fargo
Altru Cancer Center
Grand Forks
Essentia Health - Jamestown Clinic
Jamestown
Trinity Cancer Care Center
Minot
Nebraska
Nebraska Medicine-Bellevue
Bellevue
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island
CHI Health Good Samaritan
Kearney
Cancer Partners of Nebraska
Lincoln
Saint Elizabeth Regional Medical Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha
Nebraska Medicine-Village Pointe
Omaha
Nebraska Methodist Hospital
Omaha
Oncology Associates PC
Omaha
University of Nebraska Medical Center
Omaha
Midlands Community Hospital
Papillion
New Hampshire
New Hampshire Oncology Hematology PA-Concord
Concord
Elliot Hospital
Manchester
Solinsky Center for Cancer Care
Manchester
New Jersey
Ocean University Medical Center
Brick
AtlantiCare Health Park-Cape May Court House
Cape May Court House
AtlantiCare Surgery Center
Egg Harbor Township
Hackensack University Medical Center
Hackensack
Saint Barnabas Medical Center
Livingston
Southern Ocean County Medical Center
Manahawkin
Inspira Medical Center Mullica Hill
Mullica Hill
Jersey Shore Medical Center
Neptune
Rutgers Cancer Institute of New Jersey
New Brunswick
Riverview Medical Center/Booker Cancer Center
Red Bank
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Carson Tahoe Regional Medical Center
Carson City
Cancer and Blood Specialists-Henderson
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson
GenesisCare USA - Henderson
Henderson
Las Vegas Cancer Center-Henderson
Henderson
Las Vegas Urology - Green Valley
Henderson
Las Vegas Urology - Pebble
Henderson
OptumCare Cancer Care at Seven Hills
Henderson
Urology Specialists of Nevada - Green Valley
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Ann M Wierman MD LTD
Las Vegas
Cancer and Blood Specialists-Shadow
Las Vegas
Cancer and Blood Specialists-Tenaya
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
Desert West Surgery
Las Vegas
GenesisCare USA - Fort Apache
Las Vegas
GenesisCare USA - Las Vegas
Las Vegas
GenesisCare USA - Vegas Tenaya
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas
Hope Cancer Care of Nevada
Las Vegas
Las Vegas Cancer Center-Medical Center
Las Vegas
Las Vegas Prostate Cancer Center
Las Vegas
Las Vegas Urology - Cathedral Rock
Las Vegas
Las Vegas Urology - Pecos
Las Vegas
Las Vegas Urology - Smoke Ranch
Las Vegas
Las Vegas Urology - Sunset
Las Vegas
OptumCare Cancer Care at Charleston
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
OptumCare Cancer Care at MountainView
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
Sunrise Hospital and Medical Center
Las Vegas
University Cancer Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
Urology Specialists of Nevada - Central
Las Vegas
Urology Specialists of Nevada - Northwest
Las Vegas
Urology Specialists of Nevada - Southwest
Las Vegas
Hope Cancer Care of Nevada-Pahrump
Pahrump
Radiation Oncology Associates
Reno
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Hematology Oncology Associates of Central New York-Auburn
Auburn
Montefiore Medical Center - Moses Campus
Bronx
Montefiore Medical Center-Einstein Campus
Bronx
Montefiore Medical Center-Weiler Hospital
Bronx
Hematology Oncology Associates of CNY at Camillus
Camillus
Mary Imogene Bassett Hospital
Cooperstown
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse
Glens Falls Hospital
Glens Falls
Northwell Health/Center for Advanced Medicine
Lake Success
NYP/Weill Cornell Medical Center
New York
University of Rochester
Rochester
Stony Brook University Medical Center
Stony Brook
Ohio
Indu and Raj Soin Medical Center
Beavercreek
Strecker Cancer Center-Belpre
Belpre
Saint Elizabeth Boardman Hospital
Boardman
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Adena Regional Medical Center
Chillicothe
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
Oncology Hematology Care Inc-Kenwood
Cincinnati
TriHealth Cancer Institute-Anderson
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
MetroHealth Medical Center
Cleveland
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel East Hospital
Columbus
Mount Carmel Health Center West
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Dayton Physician LLC - Englewood
Dayton
Good Samaritan Hospital - Dayton
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Premier Blood and Cancer Center
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Grady Memorial Hospital
Delaware
Columbus Oncology and Hematology Associates
Dublin
Dublin Methodist Hospital
Dublin
Armes Family Cancer Center
Findlay
Blanchard Valley Hospital
Findlay
Orion Cancer Care
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Dayton Physicians LLC-Atrium
Franklin
Central Ohio Breast and Endocrine Surgery
Gahanna
Dayton Physicians LLC-Wayne
Greenville
Miami Valley Cancer Care and Infusion
Greenville
Wayne Hospital
Greenville
Mount Carmel Grove City Hospital
Grove City
First Dayton Cancer Care
Kettering
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
Saint Rita's Medical Center
Lima
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
OhioHealth Marion General Hospital
Marion
Memorial Hospital
Marysville
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Mercy Health - Perrysburg Hospital
Perrysburg
Southern Ohio Medical Center
Portsmouth
Springfield Regional Cancer Center
Springfield
Springfield Regional Medical Center
Springfield
Mercy Health - Saint Anne Hospital
Toledo
Mercy Health - Saint Vincent Hospital
Toledo
Toledo Clinic Cancer Centers-Toledo
Toledo
Dayton Physicians LLC - Troy
Troy
Upper Valley Medical Center
Troy
Saint Joseph Warren Hospital
Warren
University of Cincinnati Cancer Center-West Chester
West Chester
Saint Ann's Hospital
Westerville
Saint Elizabeth Youngstown Hospital
Youngstown
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Alphonsus Cancer Care Center-Baker City
Baker City
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
Coos Bay
Legacy Mount Hood Medical Center
Gresham
Providence Newberg Medical Center
Newberg
Saint Alphonsus Cancer Care Center-Ontario
Ontario
Providence Willamette Falls Medical Center
Oregon City
Legacy Good Samaritan Hospital and Medical Center
Portland
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Saint Charles Health System-Redmond
Redmond
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Bryn Mawr Hospital
Bryn Mawr
Christiana Care Health System-Concord Health Center
Chadds Ford
Main Line Health Center-Collegeville
Collegeville
Geisinger Medical Center
Danville
Pocono Medical Center
East Stroudsburg
Main Line Health Center-Exton
Exton
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Lehigh Valley Hospital-Hazleton
Hazleton
Penn State Milton S Hershey Medical Center
Hershey
Geisinger Medical Oncology-Lewisburg
Lewisburg
Lewistown Hospital
Lewistown
Riddle Memorial Hospital
Media
Bryn Mawr Health Center
Newtown Square
Paoli Memorial Hospital
Paoli
Jefferson Methodist Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Geisinger Cancer Services-Pottsville
Pottsville
Guthrie Medical Group PC-Robert Packer Hospital
Sayre
Community Medical Center
Scranton
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Geisinger Medical Group
State College
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
Lankenau Medical Center
Wynnewood
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Easley
Easley
Gibbs Cancer Center-Gaffney
Gaffney
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
North Grove Medical Park
Spartanburg
Spartanburg Medical Center
Spartanburg
Spartanburg Medical Center - Mary Black Campus
Spartanburg
MGC Hematology Oncology-Union
Union
South Dakota
Avera Cancer Institute-Aberdeen
Aberdeen
Rapid City Regional Hospital
Rapid City
Avera Cancer Institute
Sioux Falls
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
University Cancer Specialists - Alcoa
Alcoa
Bristol Regional Medical Center
Bristol
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville
Cookeville Regional Medical Center
Cookeville
Ballad Health Cancer Care - Kingsport
Kingsport
Wellmont Holston Valley Hospital and Medical Center
Kingsport
University of Tennessee - Knoxville
Knoxville
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Texas
Dell Seton Medical Center at The University of Texas
Austin
Saint Joseph Regional Cancer Center
Bryan
Parkland Memorial Hospital
Dallas
UT Southwestern Simmons Cancer Center - RedBird
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth
University of Texas Medical Branch
Galveston
Memorial Hermann Texas Medical Center
Houston
Doctor's Hospital of Laredo
Laredo
UT Southwestern Clinical Center at Richardson/Plano
Richardson
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork
Sandra L Maxwell Cancer Center
Cedar City
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center
Provo
Riverton Hospital
Riverton
Saint George Regional Medical Center
Saint George
LDS Hospital
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
Ballad Health Cancer Care - Bristol
Bristol
Augusta Health Center for Cancer and Blood Disorders
Fishersville
Centra Alan B Pearson Regional Cancer Center
Lynchburg
Bon Secours Memorial Regional Medical Center
Mechanicsville
Bon Secours Saint Francis Medical Center
Midlothian
Bon Secours Westchester Emergency Center
Midlothian
Bon Secours DePaul Medical Center
Norfolk
Ballad Health Cancer Care - Norton
Norton
Bon Secours Maryview Medical Center
Portsmouth
Bon Secours Cancer Institute at Reynolds Crossing
Richmond
Bon Secours Saint Mary's Hospital
Richmond
Virginia Commonwealth University/Massey Cancer Center
Richmond
VCU Community Memorial Health Center
South Hill
Bon Secours Health Center at Harbour View
Suffolk
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
MultiCare Auburn Medical Center
Auburn
Overlake Medical Center
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Saint Elizabeth Hospital
Enumclaw
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
MultiCare Gig Harbor Medical Park
Gig Harbor
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Jefferson Healthcare
Port Townsend
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
MultiCare Good Samaritan Hospital
Puyallup
Valley Medical Center
Renton
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Providence Regional Cancer System-Shelton
Shelton
Saint Michael Cancer Center
Silverdale
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley
Franciscan Research Center-Northwest Medical Plaza
Tacoma
Mary Bridge Children's Hospital and Health Center
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver
Legacy Salmon Creek Hospital
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
Langlade Hospital and Cancer Center
Antigo
ThedaCare Regional Cancer Center
Appleton
Duluth Clinic Ashland
Ashland
Northwest Wisconsin Cancer Center
Ashland
HSHS Sacred Heart Hospital
Eau Claire
Marshfield Medical Center-EC Cancer Center
Eau Claire
Bellin Memorial Hospital
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
SSM Health Dean Medical Group - South Madison Campus
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
Holy Family Memorial Hospital
Manitowoc
Marshfield Medical Center-Marshfield
Marshfield
Aspirus Medford Hospital
Medford
Froedtert Menomonee Falls Hospital
Menomonee Falls
Medical College of Wisconsin
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
ProHealth D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander
Marshfield Medical Center-Rice Lake
Rice Lake
HSHS Saint Nicholas Hospital
Sheboygan
Aspirus Cancer Care - Stevens Point
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Aspirus Regional Cancer Center
Wausau
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend
Marshfield Medical Center - Weston
Weston
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids
West Virginia
United Hospital Center
Bridgeport
West Virginia University Charleston Division
Charleston
Edwards Comprehensive Cancer Center
Huntington
WVUH-Berkely Medical Center
Martinsburg
West Virginia University Healthcare
Morgantown
Camden Clark Medical Center
Parkersburg
Wyoming
Cheyenne Regional Medical Center-West
Cheyenne
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Other Locations
Puerto Rico
Pan American Center for Oncology Trials LLC
San Juan
Time Frame
Start Date: 2019-06-07
Completion Date: 2025-09-15
Participants
Target number of participants: 1175
Treatments
Active_comparator: Arm A (nivolumab)
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~TREATMENT:~Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity~Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Patients with non-CR/non-PD with clinical stability receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Patients undergo CT scan, MRI and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.
Experimental: Arm B (nivolumab, cabozantinib)
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~TREATMENT:~Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity.~Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Patients with non-CR/non-PD rwith clinical stability eceive nivolumab IV over 30 minutes on day 1 and cabozantinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Patients undergo CT scan, MRI and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.
Authors
Mei Tang, Kathleen J. Yost, Musharraf Navaid, Leonard J. Seigel, Mei Dong, Stephanie A. Berg, Charles H. Redfern, Robert J. Behrens, Hassan I. Tahsildar, Ralph J. Hauke, Christopher M. George, Joni A. Tilford, Robert S. Alter, Bryan A. Faller, Anthony P. Gulati, Rakesh Gaur, Michael Humeniuk, Preston D. Steen, Philip A. Lowry, Rex B. Mowat, Sindhu Singh, Vijay Chaudhary, Asheesh Shipstone, Grant R. Seeger, Howard M. Gross, Jay W. Carlson, Julio J. Hajdenberg, Harsha V. Poola, Elaine T. Lam, Joseph Sokhn, Jeffrey J. Kirshner, Jeffrey Crawford, Vamsi K. Vasireddy, Mark A. Taylor, Alan Tan, Marc R. Matrana, Namita Sharma, Timothy R. Wassenaar, Howard A. Zaren, James E. Radford, Samer S. Kasbari, Hamid Emamekhoo, Donald J. Jurgens, Sarah J. Sinclair, Brian C. Myre, James M. Heun, Thomas E. Lad, Paul M. Barr, John M. Schallenkamp, John A. Ellerton, Li Zhang, John P. Stoutenburg, Keren Sturtz, John C. Henegan, Ana M. Molina, Suzanne M. Cole, Madhu Unnikrishnan, Joshua Lukenbill, Ryan F. Porter, Catherine E. Moore, Raymond Thertulien, Alexander Menter, Puja Nistala, Lynn J. Howie, Alison K. Conlin, Asit K. Paul, Robert D. Siegel, Misbah U. Qadir, Theodore S. Gourdin, Nicholas DiBella, Donald B. Wender, Taylor M. Ortiz, Ki Y. Chung, Mamta Parikh, Arpita Desai, Nafisa D. Burhani, Debra M. Prow, Benjamin A. Gartrell, Toni K. Choueiri, Anibal Drelichman, Yuanquan Yang, Jacqueline Vuky, Bagi R. Jana, Shaker R. Dakhil, Sharon D. Luikart, Nabil Adra, Douglas J. Weckstein, Pasquale W. Benedetto, Anish B. Parikh, Daniel Landau, David S. Hanson, Praveen Vashist, Benjamin M. Solomon, Timothy S. Collins, Peng Wang, Marcia R. Cruz-Correa, Kelvin B. Raybon, Uzair B. Chaudhary, Preston S. Gable, Joseph I. Clark, Amir Kamran, Boone W. Goodgame, Augusto C. Ochoa, David J. Tamura, Anthony J. Jaslowski, Shenhong Wu, Patrick Mille, Peter Rubin, Benjamin A. Teply, Jennifer L. Heaberlin, Rhonda L. Bitting, Kushal Naha, Louis C. Garrot, Richard L. Deming, Mark F. Kozloff, Walter M. Stadler, Carl J. Minniti, Neha Maithel, David VanderWeele, Albert S. DeNittis, Thomas J. Summers, Eric Bravin, Haythem Y. Ali, Shreya Sinha, Michael M. Goodman, Jonathan A. Chatzkel, Bradley A. McGregor, Jianqing Lin, Matthew I. Milowsky, Monika Joshi, Deepak Kilari, Thomas P. Bradley, William J. Irvin, Shuchi Gulati, Pedro M. Barata, Gregory A. Masters, Samip Master, Eric A. Singer, Abhishek Tripathi, Tracy L. Rose, Harish G. Ahuja, Rajasree P. Chowdry, Seth O. Fagbemi, Shahid S. Ahmed, Saikrishna Gadde
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov