Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial
Purpose
This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.
Conditions
- Metastatic Renal Cell Carcinoma
- Stage III Renal Cell Cancer AJCC v8
- Stage IV Renal Cell Cancer AJCC v8
- Unresectable Renal Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration - Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup: - History/physical examination within 45 days prior to registration - CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration - Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>= 3 factors) - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor - Patient not recommended for or refused immediate cytoreductive nephrectomy - Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen - Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging - Age >= 18 - Karnofsky performance status >= 60 within 45 days prior to registration - Hemoglobin >= 8 g/dL (transfusions are allowed) (within 45 days prior to registration) - Platelet count >= 50,000/mm^3 (within 45 days prior to registration) - Absolute neutrophil count (ANC) >= 1500/mm^3 (within 45 days prior to registration) - Calculated (Calc.) creatinine clearance >= 30 mL/min (within 45 days prior to registration) - Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault Equation - For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate - Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) (within 45 days prior to registration) - Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 3 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present (within 45 days prior to registration) - Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load - The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria
- Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment - Patients with untreated or unstable brain metastases or cranial epidural disease - Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator - Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor - Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration) - Severe, active comorbidity defined as follows: - Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease - History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies - Active tuberculosis (purified protein derivative [PPD] response without active tuberculosis [TB] is allowed) - Uncontrolled hypertension (systolic blood pressure [BP] >= 190 mmHg or diastolic BP > 110 mmHg) - Major surgery requiring hospital admission =< 28 days prior to registration - Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration - Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial infarction [NSTEMI], cerebrovascular accident [CVA], etc) events within 180 days prior to registration - Active New York (NY) Heart Association class 3-4 heart failure symptoms - Moderate or severe hepatic impairment (Child-Pugh B or C) - Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis > 30 days prior to registration is allowed) - Unstable cardiac arrhythmia within 180 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 - History of or active inflammatory bowel disease - Malabsorption syndrome within 45 days prior to registration - Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =< 45 days prior to registration
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (standard of care immunotherapy) |
Patients receive one of the following immunotherapy regimens per physician discretion: nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes every 3 weeks for 4 doses followed by nivolumab IV over 30 minutes every 2 or 4 weeks; pembrolizumab IV over 30 minutes every 3 or 6 weeks and axitinib PO BID; avelumab IV over 60 minutes every 2 weeks and axitinib PO BID; nivolumab IV over 30 minutes every 2 or 4 weeks and cabozantinib PO QD; OR pembrolizumab IV over 30 minutes every 3 or 6 weeks and lenvatinib PO QD. Treatment with immunotherapy continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial. |
|
|
Experimental Arm II (SABR, standard of care immunotherapy) |
Patients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial. |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
PCR Oncology
Arroyo Grande 5324802, California 5332921 93420
Arroyo Grande 5324802, California 5332921 93420
Mills-Peninsula Medical Center
Burlingame 5331920, California 5332921 94010
Burlingame 5331920, California 5332921 94010
UC San Diego Health System - Encinitas
Encinitas 5346646, California 5332921 92024
Encinitas 5346646, California 5332921 92024
Contact:
Site Public Contact
760-536-7700
Site Public Contact
760-536-7700
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine 5359777, California 5332921 92612
Irvine 5359777, California 5332921 92612
UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
La Jolla 5363943, California 5332921 92093
Memorial Medical Center
Modesto 5373900, California 5332921 95355
Modesto 5373900, California 5332921 95355
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville 5388881, California 5332921 95661
Roseville 5388881, California 5332921 95661
Sutter Roseville Medical Center
Roseville 5388881, California 5332921 95661
Roseville 5388881, California 5332921 95661
Sutter Medical Center Sacramento
Sacramento 5389489, California 5332921 95816
Sacramento 5389489, California 5332921 95816
UC San Diego Medical Center - Hillcrest
San Diego 5391811, California 5332921 92103
San Diego 5391811, California 5332921 92103
UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Mills Health Center
San Mateo 5392423, California 5332921 94401
San Mateo 5392423, California 5332921 94401
Ridley-Tree Cancer Center
Santa Barbara 5392952, California 5332921 93105
Santa Barbara 5392952, California 5332921 93105
Sutter Pacific Medical Foundation
Santa Rosa 5393287, California 5332921 95403
Santa Rosa 5393287, California 5332921 95403
UCHealth University of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
UCHealth - Cherry Creek
Denver 5419384, Colorado 5417618 80206
Denver 5419384, Colorado 5417618 80206
Poudre Valley Hospital
Fort Collins 5577147, Colorado 5417618 80524
Fort Collins 5577147, Colorado 5417618 80524
Contact:
Site Public Contact
970-297-6150
Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins 5577147, Colorado 5417618 80528
Fort Collins 5577147, Colorado 5417618 80528
UCHealth Greeley Hospital
Greeley 5577592, Colorado 5417618 80631
Greeley 5577592, Colorado 5417618 80631
UCHealth Highlands Ranch Hospital
Highlands Ranch 5425043, Colorado 5417618 80129
Highlands Ranch 5425043, Colorado 5417618 80129
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
UCHealth Lone Tree Health Center
Lone Tree 5429208, Colorado 5417618 80124
Lone Tree 5429208, Colorado 5417618 80124
Medical Center of the Rockies
Loveland 5579368, Colorado 5417618 80538
Loveland 5579368, Colorado 5417618 80538
Contact:
Site Public Contact
970-203-7083
Site Public Contact
970-203-7083
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura 4146429, Florida 4155751 33180
Aventura 4146429, Florida 4155751 33180
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood 4158928, Florida 4155751 33021
Hollywood 4158928, Florida 4155751 33021
Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224-9980
Jacksonville 4160021, Florida 4155751 32224-9980
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Miami Cancer Institute
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
Contact:
Site Public Contact
786-596-2000
Site Public Contact
786-596-2000
Mount Sinai Medical Center
Miami Beach 4164143, Florida 4155751 33140
Miami Beach 4164143, Florida 4155751 33140
Memorial Hospital West
Pembroke Pines 4168139, Florida 4155751 33028
Pembroke Pines 4168139, Florida 4155751 33028
Contact:
Site Public Contact
954-265-4325
Site Public Contact
954-265-4325
Alton Memorial Hospital
Alton 4232679, Illinois 4896861 62002
Alton 4232679, Illinois 4896861 62002
Contact:
Site Public Contact
618-463-7323
Site Public Contact
618-463-7323
Centralia Oncology Clinic
Centralia 4235587, Illinois 4896861 62801
Centralia 4235587, Illinois 4896861 62801
Northwestern University
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Danville 4889426, Illinois 4896861 61832
Cancer Care Specialists of Illinois - Decatur
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
DeKalb 4889553, Illinois 4896861 60115
Carle Physician Group-Effingham
Effingham 4237727, Illinois 4896861 62401
Effingham 4237727, Illinois 4896861 62401
Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Effingham 4237727, Illinois 4896861 62401
Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Geneva 4893591, Illinois 4896861 60134
Northwestern Medicine Glenview Outpatient Center
Glenview 4893886, Illinois 4896861 60026
Glenview 4893886, Illinois 4896861 60026
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake 4894465, Illinois 4896861 60030
Grayslake 4894465, Illinois 4896861 60030
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Lake Forest Hospital
Lake Forest 4899012, Illinois 4896861 60045
Lake Forest 4899012, Illinois 4896861 60045
Carle Physician Group-Mattoon/Charleston
Mattoon 4244099, Illinois 4896861 61938
Mattoon 4244099, Illinois 4896861 61938
Cancer Care Center of O'Fallon
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
HSHS Saint Elizabeth's Hospital
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
UW Health Carbone Cancer Center Rockford
Rockford 4907959, Illinois 4896861 61114
Rockford 4907959, Illinois 4896861 61114
Memorial Hospital East
Shiloh 4249910, Illinois 4896861 62269
Shiloh 4249910, Illinois 4896861 62269
Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Springfield Memorial Hospital
Springfield 4250542, Illinois 4896861 62781
Springfield 4250542, Illinois 4896861 62781
Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
The Carle Foundation Hospital
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Warrenville 4915525, Illinois 4896861 60555
Mary Greeley Medical Center
Ames 4846834, Iowa 4862182 50010
Ames 4846834, Iowa 4862182 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames 4846834, Iowa 4862182 50010
Ames 4846834, Iowa 4862182 50010
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny 4846960, Iowa 4862182 50023
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive 4852065, Iowa 4862182 50325
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Iowa Methodist Medical Center
Des Moines 4853828, Iowa 4862182 50309
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines 4853828, Iowa 4862182 50309
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee 4880981, Iowa 4862182 50263
Waukee 4880981, Iowa 4862182 50263
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Louisiana Hematology Oncology Associates LLC
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Mary Bird Perkins Cancer Center - Metairie
Metairie 4333177, Louisiana 4331987 70002
Metairie 4333177, Louisiana 4331987 70002
Contact:
Site Public Contact
504-584-6990
Site Public Contact
504-584-6990
Beverly Hospital
Beverly 4930505, Massachusetts 6254926 01915
Beverly 4930505, Massachusetts 6254926 01915
Contact:
Site Public Contact
978-922-3000
Site Public Contact
978-922-3000
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Contact:
Site Public Contact
877-726-5130
Site Public Contact
877-726-5130
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
Contact:
Site Public Contact
617-724-5200
Site Public Contact
617-724-5200
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Contact:
Site Public Contact
877-442-3324
Site Public Contact
877-442-3324
Lahey Hospital and Medical Center
Burlington 4931737, Massachusetts 6254926 01805
Burlington 4931737, Massachusetts 6254926 01805
Addison Gilbert Hospital
Gloucester 4937829, Massachusetts 6254926 01930
Gloucester 4937829, Massachusetts 6254926 01930
Contact:
Site Public Contact
978-283-4000
Site Public Contact
978-283-4000
Lahey Medical Center-Peabody
Peabody 4946863, Massachusetts 6254926 01960
Peabody 4946863, Massachusetts 6254926 01960
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48106
Ann Arbor 4984247, Michigan 5001836 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Trinity Health Medical Center - Brighton
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Trinity Health Medical Center - Canton
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Corewell Health Dearborn Hospital
Dearborn 4990510, Michigan 5001836 48124
Dearborn 4990510, Michigan 5001836 48124
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Corewell Health Farmington Hills Hospital
Farmington Hills 4992523, Michigan 5001836 48336
Farmington Hills 4992523, Michigan 5001836 48336
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
University of Michigan Health - Sparrow Lansing
Lansing 4998830, Michigan 5001836 48912
Lansing 4998830, Michigan 5001836 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia 4999837, Michigan 5001836 48154
Livonia 4999837, Michigan 5001836 48154
Corewell Health William Beaumont University Hospital
Royal Oak 5007804, Michigan 5001836 48073
Royal Oak 5007804, Michigan 5001836 48073
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Corewell Health Beaumont Troy Hospital
Troy 5012639, Michigan 5001836 48085
Troy 5012639, Michigan 5001836 48085
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti 5015688, Michigan 5001836 48197
Ypsilanti 5015688, Michigan 5001836 48197
Sanford Joe Lueken Cancer Center
Bemidji 5017822, Minnesota 5037779 56601
Bemidji 5017822, Minnesota 5037779 56601
Essentia Health Saint Joseph's Medical Center
Brainerd 5019116, Minnesota 5037779 56401
Brainerd 5019116, Minnesota 5037779 56401
Essentia Health - Deer River Clinic
Deer River 5024099, Minnesota 5037779 56636
Deer River 5024099, Minnesota 5037779 56636
Essentia Health Cancer Center
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Essentia Health Saint Mary's Medical Center
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Miller-Dwan Hospital
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Fairview Southdale Hospital
Edina 5025264, Minnesota 5037779 55435
Edina 5025264, Minnesota 5037779 55435
Essentia Health Hibbing Clinic
Hibbing 5030005, Minnesota 5037779 55746
Hibbing 5030005, Minnesota 5037779 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Hennepin County Medical Center
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55415
Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Regions Hospital
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55101
Essentia Health Sandstone
Sandstone 5045908, Minnesota 5037779 55072
Sandstone 5045908, Minnesota 5037779 55072
Lakeview Hospital
Stillwater 5048814, Minnesota 5037779 55082
Stillwater 5048814, Minnesota 5037779 55082
Essentia Health Virginia Clinic
Virginia 5051468, Minnesota 5037779 55792
Virginia 5051468, Minnesota 5037779 55792
Saint Francis Medical Center
Cape Girardeau 4379966, Missouri 4398678 63703
Cape Girardeau 4379966, Missouri 4398678 63703
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters 4407237, Missouri 4398678 63376
City of Saint Peters 4407237, Missouri 4398678 63376
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia 4381982, Missouri 4398678 65212
Columbia 4381982, Missouri 4398678 65212
Contact:
Site Public Contact
573-882-7440
Site Public Contact
573-882-7440
Siteman Cancer Center at West County Hospital
Creve Coeur 4382837, Missouri 4398678 63141
Creve Coeur 4382837, Missouri 4398678 63141
Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63128
Siteman Cancer Center-South County
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63129
Siteman Cancer Center at Christian Hospital
St Louis 4407066, Missouri 4398678 63136
St Louis 4407066, Missouri 4398678 63136
Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Nebraska Medicine-Bellevue
Bellevue 5063805, Nebraska 5073708 68123
Bellevue 5063805, Nebraska 5073708 68123
Nebraska Medicine-Village Pointe
Omaha 5074472, Nebraska 5073708 68118
Omaha 5074472, Nebraska 5073708 68118
Contact:
Site Public Contact
402-559-5600
Site Public Contact
402-559-5600
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Omaha 5074472, Nebraska 5073708 68198
Memorial Sloan Kettering Basking Ridge
Basking Ridge 5095409, New Jersey 5101760 07920
Basking Ridge 5095409, New Jersey 5101760 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Cooper Hospital University Medical Center
Camden 4501018, New Jersey 5101760 08103
Camden 4501018, New Jersey 5101760 08103
Contact:
Site Public Contact
856-325-6757
Site Public Contact
856-325-6757
Monmouth Medical Center Southern Campus
Lakewood 5100280, New Jersey 5101760 08701
Lakewood 5100280, New Jersey 5101760 08701
Monmouth Medical Center
Long Branch 5100619, New Jersey 5101760 07740
Long Branch 5100619, New Jersey 5101760 07740
Memorial Sloan Kettering Monmouth
Middletown 5101170, New Jersey 5101760 07748
Middletown 5101170, New Jersey 5101760 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale 5101361, New Jersey 5101760 07645
Montvale 5101361, New Jersey 5101760 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Cooper CyberKnife Center
Mount Laurel 4503136, New Jersey 5101760 08054
Mount Laurel 4503136, New Jersey 5101760 08054
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08903
New Brunswick 5101717, New Jersey 5101760 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Rutgers New Jersey Medical School
Newark 5101798, New Jersey 5101760 07101
Newark 5101798, New Jersey 5101760 07101
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Community Medical Center
Toms River 4504476, New Jersey 5101760 08755
Toms River 4504476, New Jersey 5101760 08755
Lovelace Medical Center-Saint Joseph Square
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87102
Lovelace Radiation Oncology
Albuquerque 5454711, New Mexico 5481136 87109
Albuquerque 5454711, New Mexico 5481136 87109
Memorial Sloan Kettering Commack
Commack 5113412, New York 5128638 11725
Commack 5113412, New York 5128638 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Glens Falls Hospital
Glens Falls 5118693, New York 5128638 12801
Glens Falls 5118693, New York 5128638 12801
Contact:
Site Public Contact
518-926-6700
Site Public Contact
518-926-6700
Memorial Sloan Kettering Westchester
Harrison 5120095, New York 5128638 10604
Harrison 5120095, New York 5128638 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Nassau
Uniondale 5141927, New York 5128638 11553
Uniondale 5141927, New York 5128638 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27599
Chapel Hill 4460162, North Carolina 4482348 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28203
Charlotte 4460243, North Carolina 4482348 28203
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Atrium Health Pineville/LCI-Pineville
Charlotte 4460243, North Carolina 4482348 28210
Charlotte 4460243, North Carolina 4482348 28210
Contact:
Site Public Contact
980-442-2000
Site Public Contact
980-442-2000
Atrium Health University City/LCI-University
Charlotte 4460243, North Carolina 4482348 28262
Charlotte 4460243, North Carolina 4482348 28262
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Levine Cancer Institute-Ballantyne
Charlotte 4460243, North Carolina 4482348 28277
Charlotte 4460243, North Carolina 4482348 28277
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Wake Forest University at Clemmons
Clemmons 4461015, North Carolina 4482348 27012
Clemmons 4461015, North Carolina 4482348 27012
Contact:
Site Public Contact
888-716-9259
Site Public Contact
888-716-9259
Atrium Health Cabarrus/LCI-Concord
Concord 4461574, North Carolina 4482348 28025
Concord 4461574, North Carolina 4482348 28025
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
Levine Cancer Institute-Gaston
Gastonia 4467732, North Carolina 4482348 28054
Gastonia 4467732, North Carolina 4482348 28054
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Hayworth Cancer Center
High Point 4471025, North Carolina 4482348 27262
High Point 4471025, North Carolina 4482348 27262
Contact:
Site Public Contact
336-802-2500
Site Public Contact
336-802-2500
Atrium Health Union/LCI-Union
Monroe 4479946, North Carolina 4482348 28112
Monroe 4479946, North Carolina 4482348 28112
Contact:
Site Public Contact
980-442-2000
Site Public Contact
980-442-2000
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro 4499138, North Carolina 4482348 28659
Wilkesboro 4499138, North Carolina 4482348 28659
Contact:
Site Public Contact
888-716-9253
Site Public Contact
888-716-9253
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Sanford Bismarck Medical Center
Bismarck 5688025, North Dakota 5690763 58501
Bismarck 5688025, North Dakota 5690763 58501
Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Sanford Roger Maris Cancer Center
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
UH Seidman Cancer Center at UH Avon Health Center
Avon 5146277, Ohio 5165418 44011
Avon 5146277, Ohio 5165418 44011
Contact:
Site Public Contact
800-641-2422
Site Public Contact
800-641-2422
UHHS-Chagrin Highlands Medical Center
Beachwood 5146711, Ohio 5165418 44122
Beachwood 5146711, Ohio 5165418 44122
Dayton Physicians LLC-Miami Valley South
Centerville 4508204, Ohio 5165418 45459
Centerville 4508204, Ohio 5165418 45459
Miami Valley Hospital South
Centerville 4508204, Ohio 5165418 45459
Centerville 4508204, Ohio 5165418 45459
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Case Western Reserve University
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
Miami Valley Hospital
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Premier Blood and Cancer Center
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-276-8320
Site Public Contact
937-276-8320
Dayton Physician LLC - Englewood
Dayton 4509884, Ohio 5165418 45415
Dayton 4509884, Ohio 5165418 45415
Miami Valley Hospital North
Dayton 4509884, Ohio 5165418 45415
Dayton 4509884, Ohio 5165418 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin 4512203, Ohio 5165418 45005-1066
Franklin 4512203, Ohio 5165418 45005-1066
Dayton Physicians LLC-Atrium
Franklin 4512203, Ohio 5165418 45005
Franklin 4512203, Ohio 5165418 45005
Miami Valley Cancer Care and Infusion
Greenville 5156493, Ohio 5165418 45331
Greenville 5156493, Ohio 5165418 45331
Contact:
Site Public Contact
937-569-7515
Site Public Contact
937-569-7515
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor 5162645, Ohio 5165418 44060
Mentor 5162645, Ohio 5165418 44060
University Hospitals Parma Medical Center
Parma 5166177, Ohio 5165418 44129
Parma 5166177, Ohio 5165418 44129
University Hospitals Portage Medical Center
Ravenna 5167737, Ohio 5165418 44266
Ravenna 5167737, Ohio 5165418 44266
Upper Valley Medical Center
Troy 5174358, Ohio 5165418 45373
Troy 5174358, Ohio 5165418 45373
University of Cincinnati Cancer Center-West Chester
West Chester 4520522, Ohio 5165418 45069
West Chester 4520522, Ohio 5165418 45069
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa 4553433, Oklahoma 4544379 74146
Tulsa 4553433, Oklahoma 4544379 74146
Contact:
Site Public Contact
918-505-3200
Site Public Contact
918-505-3200
Lehigh Valley Hospital-Cedar Crest
Allentown 5178127, Pennsylvania 6254927 18103
Allentown 5178127, Pennsylvania 6254927 18103
UPMC-Heritage Valley Health System Beaver
Beaver 5179446, Pennsylvania 6254927 15009
Beaver 5179446, Pennsylvania 6254927 15009
Lehigh Valley Hospital - Muhlenberg
Bethlehem 5180225, Pennsylvania 6254927 18017
Bethlehem 5180225, Pennsylvania 6254927 18017
Carlisle Regional Cancer Center
Carlisle 5183234, Pennsylvania 6254927 17015
Carlisle 5183234, Pennsylvania 6254927 17015
UPMC Hillman Cancer Center Erie
Erie 5188843, Pennsylvania 6254927 16505
Erie 5188843, Pennsylvania 6254927 16505
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg 5192029, Pennsylvania 6254927 15601
Greensburg 5192029, Pennsylvania 6254927 15601
Contact:
Site Public Contact
724-838-1900
Site Public Contact
724-838-1900
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg 5192726, Pennsylvania 6254927 17109
Harrisburg 5192726, Pennsylvania 6254927 17109
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Mechanicsburg 5200657, Pennsylvania 6254927 17050
UPMC Hillman Cancer Center - New Castle
New Castle 5203127, Pennsylvania 6254927 16105
New Castle 5203127, Pennsylvania 6254927 16105
UPMC-Magee Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Site Public Contact
412-647-2811
Site Public Contact
412-647-2811
UPMC-Saint Margaret
Pittsburgh 5206379, Pennsylvania 6254927 15215
Pittsburgh 5206379, Pennsylvania 6254927 15215
Contact:
Site Public Contact
412-784-4900
Site Public Contact
412-784-4900
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh 5206379, Pennsylvania 6254927 15232
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
UPMC-Shadyside Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15232
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Site Public Contact
412-621-2334
Site Public Contact
412-621-2334
UPMC-Passavant Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15237
Pittsburgh 5206379, Pennsylvania 6254927 15237
Contact:
Site Public Contact
412-367-6454
Site Public Contact
412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15243
Pittsburgh 5206379, Pennsylvania 6254927 15243
Contact:
Site Public Contact
412-502-3920
Site Public Contact
412-502-3920
Reading Hospital
West Reading 5218867, Pennsylvania 6254927 19611
West Reading 5218867, Pennsylvania 6254927 19611
Contact:
Site Public Contact
610-988-9323
Site Public Contact
610-988-9323
Divine Providence Hospital
Williamsport 5219585, Pennsylvania 6254927 17754
Williamsport 5219585, Pennsylvania 6254927 17754
UPMC Memorial
York 4562407, Pennsylvania 6254927 17408
York 4562407, Pennsylvania 6254927 17408
Contact:
Site Public Contact
717-724-6760
Site Public Contact
717-724-6760
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
Self Regional Healthcare
Greenwood 4580569, South Carolina 4597040 29646
Greenwood 4580569, South Carolina 4597040 29646
Sanford Cancer Center Oncology Clinic
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Parkland Memorial Hospital
Dallas 4684888, Texas 4736286 75235
Dallas 4684888, Texas 4736286 75235
UT Southwestern Simmons Cancer Center - RedBird
Dallas 4684888, Texas 4736286 75237
Dallas 4684888, Texas 4736286 75237
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286 75390
Dallas 4684888, Texas 4736286 75390
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
UT Southwestern Clinical Center at Richardson/Plano
Richardson 4722625, Texas 4736286 75080
Richardson 4722625, Texas 4736286 75080
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners 5233780, Vermont 5242283 05602
Berlin Corners 5233780, Vermont 5242283 05602
Contact:
Site Public Contact
802-225-5400
Site Public Contact
802-225-5400
University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
Burlington 5234372, Vermont 5242283 05401
University of Vermont and State Agricultural College
Burlington 5234372, Vermont 5242283 05405
Burlington 5234372, Vermont 5242283 05405
Bon Secours Saint Francis Medical Center
Midlothian 4772943, Virginia 6254928 23114
Midlothian 4772943, Virginia 6254928 23114
Bon Secours Cancer Institute at Reynolds Crossing
Richmond 4781708, Virginia 6254928 23230
Richmond 4781708, Virginia 6254928 23230
Virginia Mason Medical Center
Seattle 5809844, Washington 5815135 98101
Seattle 5809844, Washington 5815135 98101
West Virginia University Charleston Division
Charleston 4801859, West Virginia 4826850 25304
Charleston 4801859, West Virginia 4826850 25304
Contact:
Site Public Contact
304-388-9944
Site Public Contact
304-388-9944
Edwards Comprehensive Cancer Center
Huntington 4809537, West Virginia 4826850 25701
Huntington 4809537, West Virginia 4826850 25701
Langlade Hospital and Cancer Center
Antigo 5244010, Wisconsin 5279468 54409
Antigo 5244010, Wisconsin 5279468 54409
Duluth Clinic Ashland
Ashland 5244247, Wisconsin 5279468 54806
Ashland 5244247, Wisconsin 5279468 54806
Northwest Wisconsin Cancer Center
Ashland 5244247, Wisconsin 5279468 54806
Ashland 5244247, Wisconsin 5279468 54806
Marshfield Medical Center-EC Cancer Center
Eau Claire 5251436, Wisconsin 5279468 54701
Eau Claire 5251436, Wisconsin 5279468 54701
Essentia Health-Hayward Clinic
Hayward 5255882, Wisconsin 5279468 54843
Hayward 5255882, Wisconsin 5279468 54843
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison 5261457, Wisconsin 5279468 53718
Madison 5261457, Wisconsin 5279468 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468 53792
Madison 5261457, Wisconsin 5279468 53792
Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468 54449
Marshfield 5261969, Wisconsin 5279468 54449
Froedtert Menomonee Falls Hospital
Menomonee Falls 5262630, Wisconsin 5279468 53051
Menomonee Falls 5262630, Wisconsin 5279468 53051
Contact:
Site Public Contact
262-257-5100
Site Public Contact
262-257-5100
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
Marshfield Medical Center - Minocqua
Minocqua 5263156, Wisconsin 5279468 54548
Minocqua 5263156, Wisconsin 5279468 54548
ProHealth D N Greenwald Center
Mukwonago 5263965, Wisconsin 5279468 53149
Mukwonago 5263965, Wisconsin 5279468 53149
Cancer Center of Western Wisconsin
New Richmond 5264475, Wisconsin 5279468 54017
New Richmond 5264475, Wisconsin 5279468 54017
Drexel Town Square Health Center
Oak Creek 5265228, Wisconsin 5279468 53154
Oak Creek 5265228, Wisconsin 5279468 53154
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
ProHealth Oconomowoc Memorial Hospital
Oconomowoc 5265499, Wisconsin 5279468 53066
Oconomowoc 5265499, Wisconsin 5279468 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander 5268720, Wisconsin 5279468 54501
Rhinelander 5268720, Wisconsin 5279468 54501
Marshfield Medical Center-Rice Lake
Rice Lake 5268798, Wisconsin 5279468 54868
Rice Lake 5268798, Wisconsin 5279468 54868
Essentia Health-Spooner Clinic
Spooner 5274034, Wisconsin 5279468 54801
Spooner 5274034, Wisconsin 5279468 54801
Aspirus Cancer Care - Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54481
Stevens Point 5274644, Wisconsin 5279468 54481
Marshfield Medical Center-River Region at Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54482
Stevens Point 5274644, Wisconsin 5279468 54482
Essentia Health Saint Mary's Hospital - Superior
Superior 5275191, Wisconsin 5279468 54880
Superior 5275191, Wisconsin 5279468 54880
Contact:
Site Public Contact
701-364-6272
Site Public Contact
701-364-6272
UW Cancer Center at ProHealth Care
Waukesha 5278052, Wisconsin 5279468 53188
Waukesha 5278052, Wisconsin 5279468 53188
Aspirus Regional Cancer Center
Wausau 5278120, Wisconsin 5279468 54401
Wausau 5278120, Wisconsin 5279468 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend 5278422, Wisconsin 5279468 53095
West Bend 5278422, Wisconsin 5279468 53095
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
Marshfield Medical Center - Weston
Weston 5278693, Wisconsin 5279468 54476
Weston 5278693, Wisconsin 5279468 54476
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Contact:
Site Public Contact
715-422-7718
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT05327686
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria. SECONDARY OBJECTIVES: I. To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5 in each treatment arm. II. To assess the objective response rate (ORR) by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in each treatment arm. III. Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified indications (nephrectomy and radiographic progression-free survival [nrPFS]2). IV. Radiographic progression-free survival (rPFS). V. To assess overall survival (OS) in each treatment arm. VI. To assess the time to subsequent second-line therapy or death in each treatment arm. VII. To assess the rate of cytoreductive nephrectomy in each treatment arm. VIII. To assess treatment-free survival in patients who discontinue therapy for reason other than radiographic disease progression. IX. To assess the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST in the primary renal mass. EXPLORATORY OBJECTIVES: I. To assess composite nrPFS in the predefined histological subgroups below: Ia. Clear cell versus non-clear cell histology; Ib. International Metastatic RCC database consortium (IMDC) intermediate versus poor risk group; Ic. Systemic treatment with immunotherapy-immunotherapy combination versus immunotherapy-vascular endothelial growth factor (VEGF) targeted therapy combination; Id. Sarcomatoid versus non sarcomatoid variant. II. To identify prognostic and predictive biomarkers of response to SABR in the context of immunotherapy based treatment via assessment of tissue and blood based biomarkers. III. To evaluate the abscopal effect of SABR with systemic therapy. IIIa. Compare ORR in non-irradiated target lesions in the control arm patients undergoing immunotherapy alone to the experimental arm undergoing SABR + immunotherapy. IV. To evaluate the impact of treatment on level of inferior vena cava (IVC) thrombus. V. To compare accruing center identified iRECIST progression and centrally identified iRECIST progression events on computed tomography (CT). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive one of the following immunotherapy regimens per physician discretion: nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes every 3 weeks for 4 doses followed by nivolumab IV over 30 minutes every 2 or 4 weeks; pembrolizumab IV over 30 minutes every 3 or 6 weeks and axitinib orally (PO) twice daily (BID); avelumab IV over 60 minutes every 2 weeks and axitinib PO BID; nivolumab IV over 30 minutes every 2 or 4 weeks and cabozantinib PO once daily (QD); OR pembrolizumab IV over 30 minutes every 3 or 6 weeks and lenvatinib PO QD. Treatment with immunotherapy continues in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial. ARM II: Patients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial. After completion of study treatment, patients are followed up every 6 months for 5 years, and then annually for 3 years.