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Brentuximab Vedotin and Nivolumab with or without Ipilimumab in Treating Patients with Relapsed or Refractory Hodgkin Lymphoma

Trial Status: Active

This phase I / II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.

Inclusion Criteria

  • PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)
  • Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
  • Patients must have relapsed after first line chemotherapy; may have relapsed after autologous or allogeneic stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; if status post allogeneic stem cell transplant, no active graft versus host disease
  • Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
  • Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
  • Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) performance status between 0-2
  • Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by a diagnostic quality computed tomography (CT) scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
  • Women must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both single barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP); should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
  • Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air
  • Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
  • Absolute neutrophil count (ANC) >= 1500/mcL (1.5 x 10^9/L) (obtained within 2 weeks prior to registration)
  • Platelets >= 75,000/mcL (75 x 10^9/L) (obtained within 2 weeks prior to registration)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (obtained within 2 weeks prior to registration)
  • Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained within 2 weeks prior to registration)
  • Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)
  • No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
  • Patient must have no current or prior history of central nervous system (CNS) involvement
  • All prior therapy must have been completed at least 21 days prior to enrollment; no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
  • No history of Steven’s Johnson’s syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy
  • Human immunodeficiency virus (HIV) positive patients are allowed on this study if they have a CD4 count > 400, and are on a stable antiviral regimen; patients with poorly controlled HIV or other chronic active viral infections will be excluded
  • Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed * Replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to initiation of study treatment are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study * Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
  • Patients must not have grade 2 or greater peripheral sensory neuropathy
  • Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
  • Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
  • Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
  • Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
  • Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
  • Patients registering to Arms D, E, F, G, H, I, X, Y must not currently be smoking tobacco or other substances and must not have smoked within the past 6 months
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must have relapsed after first line chemotherapy; may have relapsed after autologous stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; patient must not have received a prior allogeneic stem cell transplant
  • RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab
  • RANDOMIZED PHASE II (ARMS K AND L): Patients may not have received other prior activating immunotherapies (i.e. checkpoint inhibitor therapies); for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
  • RANDOMIZED PHASE II (ARMS K AND L): ECOG-ACRIN performance status between 0-2
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by a diagnostic quality CT scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
  • RANDOMIZED PHASE II (ARMS K AND L): Women must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all females of childbearing potential must have a blood test or urine study within 24 hours prior to enrollment to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • RANDOMIZED PHASE II (ARMS K AND L): Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP); should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must have FEV1/FVC > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
  • RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L) (obtained within 2 weeks prior to registration)
  • RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L) (obtained within 2 weeks prior to registration)
  • RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN) (obtained within 2 weeks prior to registration)
  • RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained within 2 weeks prior to registration)
  • RANDOMIZED PHASE II (ARMS K AND L): Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)
  • RANDOMIZED PHASE II (ARMS K AND L): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
  • RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement
  • RANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
  • RANDOMIZED PHASE II (ARMS K AND L): No history of Steven’s Johnson’s syndrome, TENs syndrome, or motor neuropathy
  • RANDOMIZED PHASE II (ARMS K AND L): HIV positive patients are eligible provided they meet the other protocol criteria including the following: * Long term survival expected were it not for the cHL * HIV viral loads undetectable by standard clinical HIV testing * Willing to adhere to effective combination antiretroviral therapy
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of steroid medication for at least 2 weeks prior to initiation of therapy are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not have NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
  • RANDOMIZED PHASE II (ARMS K AND L): Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not currently be smoking tobacco or other agents
  • RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a history of or evidence of cardiovascular risks including any of the following: * QT interval corrected for heart rate using the Bazett’s formula QTcB >= 480 msec at baseline * History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration * History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system * Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multigated acquisition scan (MUGA) * Intra-cardiac defibrillator * History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study * History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible * Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy

Alabama

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Colorado

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Denver
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Durango
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Englewood
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Swedish Medical Center
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Golden
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Grand Junction
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Greeley
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Lafayette
Good Samaritan Medical Center
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Lakewood
Rocky Mountain Cancer Centers-Lakewood
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Saint Anthony Hospital
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Littleton
Littleton Adventist Hospital
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Rocky Mountain Cancer Centers-Littleton
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Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
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Sky Ridge Medical Center
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Longmont
Longmont United Hospital
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Rocky Mountain Cancer Centers-Longmont
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Loveland
McKee Medical Center
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Parker
Parker Adventist Hospital
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Rocky Mountain Cancer Centers-Parker
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Pueblo
Rocky Mountain Cancer Centers - Pueblo
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Thornton
National Jewish Health-Northern Hematology Oncology
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Rocky Mountain Cancer Centers-Thornton
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Wheat Ridge
SCL Health Lutheran Medical Center
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Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
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Hawaii

Honolulu
Kaiser Permanente Moanalua Medical Center
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Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
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Saint Luke's Mountain States Tumor Institute
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Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
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Coeur D'Alene
Kootenai Medical Center
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Emmett
Walter Knox Memorial Hospital
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Phone: 734-712-3671
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
Northwestern University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Joliet
Joliet Oncology-Hematology Associates Limited
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-730-3098
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Southwest Illinois Health Services LLP
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-236-1000
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

Evansville
Deaconess Clinic Downtown
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-654-0311
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Newburgh
Chancellor Center for Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-654-0311

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Council Bluffs
Alegent Health Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
West Des Moines
Mercy Medical Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Kentucky

Bardstown
Flaget Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Corbin
Commonwealth Cancer Center-Corbin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lexington
Saint Joseph Hospital East
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
London
Saint Joseph London
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Louisville
Jewish Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Jewish Hospital Medical Center Northeast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saints Mary and Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Shepherdsville
Jewish Hospital Medical Center South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Louisiana

Baton Rouge
LSU Health Baton Rouge-North Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Louisiana Hematology Oncology Associates LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Mary Bird Perkins Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Our Lady of the Lake Physicians Group - Medical Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Covington
Northshore Oncology Associates-Covington
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Houma
Oncology Center of The South Incorporated
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353
Terrebonne General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 985-850-6300

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-955-8804
Saint Agnes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-368-2910

Massachusetts

Boston
Tufts Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 617-636-5000

Michigan

Port Huron
Huron Medical Center PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

Minnesota

Aitkin
Riverwood Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Brainerd
Essentia Health Saint Joseph's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Deer River
Essentia Health - Deer River Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Duluth
Essentia Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Essentia Health Saint Mary's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Miller-Dwan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Fosston
Essentia Health - Fosston
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Hibbing
Essentia Health Hibbing Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Park Rapids
Essentia Health - Park Rapids
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Sandstone
Essentia Health Sandstone
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Virginia
Essentia Health Virginia Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Bonne Terre
Parkland Health Center-Bonne Terre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-651-5550
Chesterfield
Saint Luke's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-205-6936
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Frontier Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-648-6274
Saint Vincent Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Grand Island
CHI Health Saint Francis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Kearney
CHI Health Good Samaritan
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Heartland Hematology and Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lincoln
Saint Elizabeth Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Alegent Health Bergan Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Immanuel Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Lakeside Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Creighton University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Hematology and Oncology Consultants PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Papillion
Midlands Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Henderson
21st Century Oncology-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas
21st Century Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Shadow
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Jersey

Lakewood
Monmouth Medical Center Southern Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-923-6564
Long Branch
Monmouth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-923-7689
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-263-4434
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Wayne Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 919-731-6687
Jacksonville
Onslow Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 910-353-0824
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084

North Dakota

Fargo
Essentia Health Cancer Center-South University Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Jamestown
Essentia Health - Jamestown Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308

Ohio

Cincinnati
Bethesda North Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Anderson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Westside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Cleveland
MetroHealth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-778-8526

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 918-505-3200

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-531-3779
Philadelphia
Fox Chase Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-728-4790
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-474-9892

South Carolina

Greenville
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213

Tennessee

Chattanooga
Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-811-8480
Ooltewah
Memorial GYN Plus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-855-4100
Cedar City
Sandra L Maxwell Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-868-5680
Logan
Logan Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-387-7426
Riverton
Riverton Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-507-3950
Saint George
Dixie Medical Center Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
LDS Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-933-6070

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Auburn
MultiCare Auburn Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-887-9333
Bellevue
Overlake Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-688-5407
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Burien
Highline Medical Center-Main Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Centralia
Providence Regional Cancer System-Centralia
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Enumclaw
Saint Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Federal Way
Saint Francis Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-2394
Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Lakewood
Saint Clare Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Longview
PeaceHealth Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-2016
Port Townsend
Jefferson Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-344-3091
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Puyallup
MultiCare Good Samaritan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-351-7955
Renton
Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Kaiser Permanente Washington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Pacific Gynecology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Shelton
Providence Regional Cancer System-Shelton
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
MultiCare Deaconess Cancer and Blood Specialty Center - North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-402-7249
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mary Bridge Children's Hospital and Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-1461
MultiCare Tacoma General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-3229
Northwest Medical Specialties PLLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Vancouver
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

West Virginia

Bridgeport
United Hospital Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 304-293-7374
Martinsburg
WVUH-Berkely Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Parkersburg
Camden Clark Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Ashland
Duluth Clinic Ashland
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Northwest Wisconsin Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Germantown
Aurora Health Care Germantown Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Grafton
Aurora Cancer Care-Grafton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Kenosha
Aurora Cancer Care-Kenosha South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Marinette
Aurora Bay Area Medical Group-Marinette
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Milwaukee
Aurora Cancer Care-Milwaukee
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Racine
Aurora Cancer Care-Racine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Summit
Aurora Medical Center in Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
West Allis
Aurora West Allis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I)

II. To evaluate the complete response (CR) rate for the regimens of brentuximab vedotin and nivolumab compared to brentuximab vedotin, ipilimumab, and nivolumab. (Phase II)

SECONDARY OBJECTIVES:

I. To evaluate complete response (CR) rate, partial response (PR) rate and overall response rate (ORR), for the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I)

II. To evaluate the duration of remission (DOR) to these combinations and compare with the DOR achieved with the most recent prior systemic therapy. (Phase I)

III. To evaluate the progression-free survival (PFS) and the overall survival (OS) in patients receiving the combination of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I)

IV. To evaluate the ORR, PR, and stable disease (SD) rate for the combinations of brentuximab vedotin and nivolumab and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II)

V. To evaluate the DOR to these combinations and compare with the DOR achieved with the most recent prior systemic therapy. (Phase II)

VI. To evaluate the 5 year PFS and OS in patients receiving the combinations of brentuximab vedotin and nivolumab and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II)

VII. To further evaluate the safety and characterize the toxicity for the combinations of brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II)

CORRELATIVE STUDY OBJECTIVES:

I. To evaluate the ability of these combinations to alter tumor specific T cell immunity. (Phase I)

II. To evaluate the effects of these combinations on systemic immunity. (Phase I)

III. To evaluate a panel of cytokine and T cell specific biomarkers from the peripheral blood as a potential immune signature of treatment response to therapy with these combinations for patients with relapsed/refractory Hodgkin lymphoma (HL). (Phase I)

IV. To evaluate using gene expression profiling (GEP) a signature of response to these novel combinations of an antibody drug conjugate with immunomodulatory therapy. (Phase I)

V. To evaluate the ability of these combinations to alter tumor specific T cell immunity, and circulating T cell phenotypes, in patients as a function of treatment response at multiple timepoints during therapy. (Phase II)

VI. To evaluate peripheral blood cytokine profiles in responding and resistant patients at multiple timepoints during therapy. (Phase II)

VII. To evaluate using GEP a signature of response versus (vs.) resistance to these novel combinations of an antibody drug conjugate with immunomodulatory therapy. (Phase II)

VIII. To evaluate the influence of human gut microbiome dysbiosis on HL lymphomagenesis and the systemic immune response. (Phase II)

IMAGING CORRELATIVE STUDY OBJECTIVES:

I. To evaluate atypical response patterns with currently available response evaluation criteria. (Phase II)

II. To correlate response evaluated using currently available response evaluation criteria with duration of response (PFS, event free survival [EFS], failure free survival [FFS]). (Phase II)

III. To evaluate response patterns in different immunotherapy treatment schemes and correlate with historical data using chemotherapy. (Phase II)

IV. To correlate imaging changes in all treatment schemes quantitatively with PFS. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin, ipilimumab, and nivolumab followed by a phase II study.

PHASE I: Patients are assigned into 1 of 3 arms.

ARM I: Patients receive brentuximab vedotin intravenously (IV) over 90 minutes on day 1 and ipilimumab IV over 30 minutes on day 1 of cycles 1-4, 8, 12, and 16. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-46. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-46, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-34. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-34, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity.

After completion of phase I study treatment, patients are followed up every 3 months for 1 year, then every 6 months for 2 years. After completion of phase II study treatment, patients are followed up for 5 years.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Catherine S. Magid Diefenbach

  • Primary ID E4412
  • Secondary IDs NCI-2013-01275, S14-00011
  • Clinicaltrials.gov ID NCT01896999