Blood Cancer

E4412



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

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 (recurrent) or has not responded to previous treatment (refractory). 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 monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
  • PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)

  • Age >= 18 years

  • 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

  • Patient must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a patient of childbearing potential is anyone, 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)

  • Patient of childbearing potential and/or sexually active patients 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 patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patients or their partner is participating in this study, the patient (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): Age >= 12 years * Pediatric patients will include any patients < 18 years of age

  • 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 (out of risk of reactivation of pulmonary graft versus host disease [GVHD])

  • 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): Adult patient (>= 18 years of age) ECOG-ACRIN performance status between 0-2 * Pediatric patients (16-17 years of age) must have a Karnofsky performance level >= 50% * Pediatric patients (12-16 years of age) must have a Lansky performance level >= 50

  • 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): Patient must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • RANDOMIZED PHASE II (ARMS K AND L): Patient of childbearing potential and/or sexually active patient 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 patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patient or their partner is participating in this study, the patient (or the participating partner) should inform the treating physician immediately

  • RANDOMIZED PHASE II (ARMS K AND L): Patients with impaired decision-making capacity are eligible with legally authorized representative

  • 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) for age (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): Adult patients (>= 18 years old) must have a calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)

  • RANDOMIZED PHASE II (ARMS K AND L): Pediatric patients (< 18 years old) must have a creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or serum creatinine based on age/gender as follows: * Age: maximum serum creatinine (mg/dL) ** < 13 years: male (1.2), female (1.2) ** 13 to < 16 years: male (1.5), female (1.4) ** >= 16 years: male (1.7), female (1.4)

  • 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, prior solid organ transplant, 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; vaping is not allowed

  • 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

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Katmai Oncology Group
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Fairbanks
Fairbanks Memorial Hospital
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AL
Birmingham
Children's Hospital of Alabama
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University of Alabama at Birmingham Cancer Center
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AR
Ft. Smith
Mercy Hospital Fort Smith
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Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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AZ
Kingman
Kingman Regional Medical Center
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Phoenix
Cancer Center at Saint Joseph's
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CA
Antioch
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Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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PCR Oncology
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Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
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Dublin
Kaiser Permanente Dublin
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Fremont
Kaiser Permanente-Fremont
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Fresno
Fresno Cancer Center
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Modesto
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Oakland
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Kaiser Permanente-Oakland
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Orange
Children's Hospital of Orange County
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Palo Alto
Stanford Cancer Institute Palo Alto
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Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
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Redwood City
Kaiser Permanente-Redwood City
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Richmond
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Rohnert Park
Rohnert Park Cancer Center
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Roseville
Kaiser Permanente-Roseville
Status: ACTIVE
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The Permanente Medical Group-Roseville Radiation Oncology
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Sacramento
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Kaiser Permanente-South Sacramento
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South Sacramento Cancer Center
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San Francisco
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UCSF Medical Center-Mission Bay
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San Jose
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San Leandro
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San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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San Rafael
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Kaiser San Rafael-Gallinas
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Santa Clara
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Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Santa Rosa
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South San Francisco
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Stockton
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Vacaville
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Vallejo
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Walnut Creek
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CO
Aurora
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The Medical Center of Aurora
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Boulder
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Boulder Community Hospital
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Rocky Mountain Cancer Centers-Boulder
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Centennial
Rocky Mountain Cancer Centers - Centennial
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Colorado Springs
Penrose-Saint Francis Healthcare
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Rocky Mountain Cancer Centers-Penrose
Status: CLOSED_TO_ACCRUAL
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Denver
Cancer Center of Colorado at Sloan's Lake
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Colorado Blood Cancer Institute
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Denver Health Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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National Jewish Health-Main Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Email: glicht@co-cancerresearch.org

Porter Adventist Hospital
Status: CLOSED_TO_ACCRUAL
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Presbyterian - Saint Lukes Medical Center - Health One
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Rocky Mountain Cancer Centers-Midtown
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Rocky Mountain Cancer Centers-Rose
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Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Rose Medical Center
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SCL Health Saint Joseph Hospital
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The Women's Imaging Center
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Western Surgical Care
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Durango
Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
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Southwest Oncology PC
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Englewood
Mountain Blue Cancer Care Center - Swedish
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Rocky Mountain Cancer Centers - Swedish
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Swedish Medical Center
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Golden
Mountain Blue Cancer Care Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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National Jewish Health-Western Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Grand Junction
Saint Mary's Hospital and Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Greeley
North Colorado Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Lafayette
Good Samaritan Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Lakewood
Rocky Mountain Cancer Centers-Lakewood
Status: ACTIVE
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Saint Anthony Hospital
Status: CLOSED_TO_ACCRUAL
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Littleton
Littleton Adventist Hospital
Status: CLOSED_TO_ACCRUAL
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Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
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Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
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Sky Ridge Medical Center
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Longmont
Longmont United Hospital
Status: CLOSED_TO_ACCRUAL
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Rocky Mountain Cancer Centers-Longmont
Status: CLOSED_TO_ACCRUAL
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Loveland
McKee Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Email: info@westernstatesncorp.org

Parker
Parker Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Parker
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Pueblo
Rocky Mountain Cancer Centers - Pueblo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Thornton
National Jewish Health-Northern Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Rocky Mountain Cancer Centers-Thornton
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Wheat Ridge
SCL Health Lutheran Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

DC
Washington
Children's National Medical Center
Status: ACTIVE
Contact: Site Public Contact

FL
Fort Myers
Regional Cancer Center-Lee Memorial Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Saint Petersburg
Johns Hopkins All Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Ashley.Repp@jhmi.edu

Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: ACTIVE
Contact: Site Public Contact
Email: jennifer.manns@baycare.org

Tampa General Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: syapchanyk@tgh.org

GA
Atlanta
Children's Healthcare of Atlanta - Egleston
Status: ACTIVE
Contact: Site Public Contact
Email: Leann.Schilling@choa.org

Emory University Hospital / Winship Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

HI
Honolulu
Kaiser Permanente Moanalua Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: shelley.a.clark@kp.org

IA
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mercy Cancer Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mercy Medical Center - Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

West Des Moines
Mercy Medical Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Status: ACTIVE
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@northwestern.edu

Rush University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical_trials@rush.edu

University of Illinois
Status: ACTIVE
Contact: Site Public Contact

Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact

Joliet
Duly Health and Care Joliet
Status: ACTIVE
Contact: Site Public Contact
Email: Karen.Sceniak@dulyhealthandcare.com

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact

Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Evansville
Deaconess Clinic Downtown
Status: ACTIVE
Contact: Site Public Contact
Email: Research@Deaconess.com

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: iutrials@iu.edu

Newburgh
Chancellor Center for Oncology
Status: ACTIVE
Contact: Site Public Contact
Email: Research@Deaconess.com

KS
Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

KY
Bardstown
Flaget Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital East
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Shepherdsville
Jewish Hospital Medical Center South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: research@ololrmc.com

Louisiana Hematology Oncology Associates LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Our Lady of The Lake
Status: ACTIVE
Contact: Site Public Contact

Our Lady of the Lake Physicians Group - Medical Oncology
Status: ACTIVE
Contact: Site Public Contact
Email: research@ololrmc.com

Covington
Northshore Oncology Associates-Covington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Houma
Oncology Center of The South Incorporated
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Terrebonne General Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ann.hooks@tgmc.com

MA
Boston
Tufts Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

MD
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

Saint Agnes Hospital
Status: ACTIVE
Contact: Site Public Contact

Bethesda
Walter Reed National Military Medical Center
Status: ACTIVE
Contact: Site Public Contact

MI
Port Huron
Huron Medical Center PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

MN
Aitkin
Riverwood Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Brainerd
Essentia Health Saint Joseph's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Deer River
Essentia Health - Deer River Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Duluth
Essentia Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Fosston
Essentia Health - Fosston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Hibbing
Essentia Health Hibbing Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Park Rapids
Essentia Health - Park Rapids
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Rochester
Mayo Clinic in Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Sandstone
Essentia Health Sandstone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Virginia
Essentia Health Virginia Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

Bonne Terre
Parkland Health Center-Bonne Terre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Chesterfield
Saint Luke's Hospital
Status: ACTIVE
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Kansas City
Children's Mercy Hospitals and Clinics
Status: ACTIVE
Contact: Site Public Contact
Email: rryan@cmh.edu

Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact

Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact

Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact

Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@billingsclinic.org

Saint Vincent Frontier Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Vincent Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Butte
Saint James Community Hospital and Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Wayne Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecooke@cancersmoc.com

Jacksonville
Onslow Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecooke@cancersmoc.com

Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Email: jfields@cancersmoc.com

ND
Fargo
Essentia Health Cancer Center-South University Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Jamestown
Essentia Health - Jamestown Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

NE
Grand Island
CHI Health Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Heartland Hematology and Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Lincoln
Saint Elizabeth Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Hematology and Oncology Consultants PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Papillion
Midlands Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NJ
Lakewood
Monmouth Medical Center Southern Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mary.danish@rwjbh.org

Long Branch
Monmouth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mary.danish@rwjbh.org

Morristown
Morristown Medical Center
Status: ACTIVE
Contact: Site Public Contact

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: ACTIVE
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: LByatt@nmcca.org

NV
Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Shadow
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

NY
Bronx
Montefiore Medical Center - Moses Campus
Status: APPROVED
Contact: Site Public Contact
Email: eskwak@montefiore.org

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: askroswell@roswellpark.org

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org

Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Mount Sinai Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: CCTO@mssm.edu

NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: nr2616@cumc.columbia.edu

NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact

Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact

Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact

OH
Akron
Children's Hospital Medical Center of Akron
Status: ACTIVE
Contact: Site Public Contact

Cincinnati
Bethesda North Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Cincinnati Children's Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@cchmc.org

Good Samaritan Hospital - Cincinnati
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Cleveland
MetroHealth Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Columbus
Nationwide Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Melinda.Triplet@nationwidechildrens.org

OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact

PA
Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

Philadelphia
Children's Hospital of Philadelphia
Status: ACTIVE
Contact: Site Public Contact
Email: CancerTrials@email.chop.edu

Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Pennsylvania / Abramson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact

Columbia
Prisma Health Richland Hospital
Status: ACTIVE
Contact: Site Public Contact

Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

Greenville
BI-LO Charities Children's Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Greenville Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact

TN
Chattanooga
Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Knoxville
East Tennessee Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact

Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: referralinfo@stjude.org

Nashville
The Children's Hospital at TriStar Centennial
Status: ACTIVE
Contact: Site Public Contact

Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Ooltewah
Memorial GYN Plus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

TX
Austin
Dell Children's Medical Center of Central Texas
Status: ACTIVE
Contact: Site Public Contact
Email: TXAUS-DL-SFCHemonc.research@ascension.org

Bryan
Saint Joseph Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

El Paso
El Paso Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ranjan.bista@ttuhsc.edu

Fort Worth
Cook Children's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CookChildrensResearch@cookchildrens.org

San Antonio
Children's Hospital of San Antonio
Status: ACTIVE
Contact: Site Public Contact
Email: ctsucontact@westat.com

UT
American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Cedar City
Sandra L Maxwell Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Logan
Logan Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Murray
Intermountain Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Ogden
McKay-Dee Hospital Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Riverton
Riverton Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Saint George
Saint George Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Salt Lake City
LDS Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Utah Cancer Specialists-Salt Lake City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

VA
Norfolk
Children's Hospital of The King's Daughters
Status: ACTIVE
Contact: Site Public Contact
Email: CCBDCresearch@chkd.org

WI
Ashland
Duluth Clinic Ashland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Fond Du Lac
Aurora Health Center-Fond du Lac
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Germantown
Aurora Health Care Germantown Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Kenosha
Aurora Cancer Care-Kenosha South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

La Crosse
Gundersen Lutheran Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Ladysmith
Marshfield Clinic - Ladysmith Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Marinette
Aurora Bay Area Medical Group-Marinette
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Aurora Cancer Care-Milwaukee
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Aurora Cancer Care-Racine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Rice Lake
Marshfield Medical Center-Rice Lake
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Summit
Aurora Medical Center in Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Wausau
Marshfield Clinic-Wausau Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Weston
Marshfield Medical Center - Weston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Bridgeport
United Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Martinsburg
WVUH-Berkely Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Parkersburg
Camden Clark Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

WY
Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

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; adult cohort [aged >= 18 years])
III. To characterize the safety and toxicity of treatment combination in the pediatric population. (Phase II; pediatric cohort [aged 12-17 years])

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)

EXPLORATORY OBJECTIVES:
I. Evaluate outcomes (CR, PFS) between patients with/without prior transplants. (Phase II)
II. Evaluate outcomes (PFS, OS) between the patients who stay on treatment and do not go to transplant in both arms (the post auto and the few others who don't want transplant) vs the patients who go off for transplant. (Phase II)
III. Evaluate outcomes (CR, PFS) in pediatric population (age 12 to < 18 years of age) vs. adult population. (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 30 minutes on day 1 of cycles 1-16 and nivolumab IV over 90 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.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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