Blood Cancer
E4412
Brentuximab Vedotin and Nivolumab with or without Ipilimumab in Treating Patients with Relapsed or Refractory Hodgkin Lymphoma
STATUS: Temporarily Closed to Accrual
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 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
- 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 patient 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 (12-15 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 glomerular filtration rate (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
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Alaska Breast Care and Surgery LLC
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Birmingham
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Aurora
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Durango
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Englewood
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Golden
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Grand Junction
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Greeley
Banner North Colorado Medical Center
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Lakewood
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Littleton
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Lone Tree
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Loveland
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Pueblo
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Thornton
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Wheat Ridge
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DC
Washington
Children's National Medical Center
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Fort Myers
Golisano Children's Hospital of Southwest Florida
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Regional Cancer Center-Lee Memorial Health System
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Saint Petersburg
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Tampa
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Tampa General Hospital
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GA
Atlanta
Children's Healthcare of Atlanta - Egleston
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Emory University Hospital/Winship Cancer Institute
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HI
Honolulu
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IA
Clive
Mercy Cancer Center-West Lakes
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Council Bluffs
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Creston
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Des Moines
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West Des Moines
Mercy Medical Center-West Lakes
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
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Saint Luke's Cancer Institute - Boise
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Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org
Meridian
Idaho Urologic Institute-Meridian
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org
Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org
IL
Alton
Saint Anthony's Health
Contact: Site Public Contact
Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Contact: Site Public Contact
Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Chicago
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu
Rush University Medical Center
Contact: Site Public Contact
Email: clinical_trials@rush.edu
University of Illinois
Contact: Site Public Contact
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact
Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com
Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Contact: Site Public Contact
Joliet
Duly Health and Care Joliet
Contact: Site Public Contact
Email: Karen.Sceniak@dulyhealthandcare.com
Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact
O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Contact: Site Public Contact
Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com
Southern Illinois University School of Medicine
Contact: Site Public Contact
Springfield Clinic
Contact: Site Public Contact
Swansea
Southwest Illinois Health Services LLP
Contact: Site Public Contact
Email: lynns@thecancercenter.com
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com
Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
IN
Evansville
Deaconess Clinic Downtown
Contact: Site Public Contact
Email: Research@Deaconess.com
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Contact: Site Public Contact
Email: iutrials@iu.edu
Newburgh
Chancellor Center for Oncology
Contact: Site Public Contact
Email: Research@Deaconess.com
KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org
KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Lexington
Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu
Paducah
Mercy Health - Paducah Cancer Center
Contact: Site Public Contact
Email: BJWarner@mercy.com
Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: research@ololrmc.com
Louisiana Hematology Oncology Associates LLC
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Mary Bird Perkins Cancer Center
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Our Lady of The Lake
Contact: Site Public Contact
Our Lady of the Lake Physician Group
Contact: Site Public Contact
Email: research@ololrmc.com
Covington
Northshore Oncology Associates-Covington
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Houma
Oncology Center of The South Incorporated
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Terrebonne General Medical Center
Contact: Site Public Contact
Email: ann.hooks@tgmc.com
MA
Boston
Tufts Medical Center
Contact: Site Public Contact
Email: ContactUsCancerCenter@TuftsMedicalCenter.org
MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Contact: Site Public Contact
Email: jhcccro@jhmi.edu
Saint Agnes Hospital
Contact: Site Public Contact
Bethesda
Walter Reed National Military Medical Center
Contact: Site Public Contact
MI
Port Huron
Huron Medical Center PC
Contact: Site Public Contact
Email: research@sncrf.org
Lake Huron Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
MN
Aitkin
Riverwood Healthcare Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Brainerd
Essentia Health Saint Joseph's Medical Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Deer River
Essentia Health - Deer River Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Duluth
Essentia Health Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Essentia Health Saint Mary's Medical Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Miller-Dwan Hospital
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Fosston
Essentia Health - Fosston
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Hibbing
Essentia Health Hibbing Clinic
Contact: Site Public Contact
Park Rapids
Essentia Health - Park Rapids
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
Sandstone
Essentia Health Sandstone
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Virginia
Essentia Health Virginia Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact
Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org
Bonne Terre
Parkland Health Center-Bonne Terre
Contact: Site Public Contact
Branson
Cox Cancer Center Branson
Contact: Site Public Contact
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net
Southeast Cancer Center
Contact: Site Public Contact
Chesterfield
Saint Luke's Hospital
Contact: Site Public Contact
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact
Jefferson City
MU Health Care Goldschmidt Cancer Center
Contact: Site Public Contact
Email: amy.franken@health.missouri.edu
Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net
Kansas City
Children's Mercy Hospitals and Clinics
Contact: Site Public Contact
Email: rryan@cmh.edu
Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact
Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact
Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net
Missouri Baptist Medical Center
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact
Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact
Springfield
CoxHealth South Hospital
Contact: Site Public Contact
Mercy Hospital Springfield
Contact: Site Public Contact
Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact
Sunset Hills
BJC Outpatient Center at Sunset Hills
Contact: Site Public Contact
Washington
Mercy Hospital Washington
Contact: Site Public Contact
MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org
Saint Vincent Frontier Cancer Center
Contact: Site Public Contact
Saint Vincent Healthcare
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Bozeman
Bozeman Health Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Butte
Saint James Community Hospital and Cancer Treatment Center
Contact: Site Public Contact
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Missoula
Community Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org
NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Contact: Site Public Contact
Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Wayne Memorial Hospital
Contact: Site Public Contact
Email: ecooke@cancersmoc.com
Jacksonville
Onslow Memorial Hospital
Contact: Site Public Contact
Email: ecooke@cancersmoc.com
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com
ND
Fargo
Essentia Health Cancer Center-South University Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Jamestown
Essentia Health - Jamestown Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
Contact: Site Public Contact
Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Heartland Hematology and Oncology
Contact: Site Public Contact
Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Hematology and Oncology Consultants PC
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
NJ
Hackensack
Hackensack University Medical Center
Contact: Site Public Contact
Lakewood
Monmouth Medical Center Southern Campus
Contact: Site Public Contact
Email: mary.danish@rwjbh.org
Long Branch
Monmouth Medical Center
Contact: Site Public Contact
Email: mary.danish@rwjbh.org
Morristown
Morristown Medical Center
Contact: Site Public Contact
New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Contact: Site Public Contact
NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu
NV
Carson City
Carson Tahoe Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
Henderson
Cancer and Blood Specialists-Henderson
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Henderson
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Contact: Site Public Contact
Email: research@sncrf.org
GenesisCare USA - Henderson
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Cancer Center-Henderson
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Urology - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Urology - Pebble
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org
Urology Specialists of Nevada - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: research@sncrf.org
Ann M Wierman MD LTD
Contact: Site Public Contact
Email: research@sncrf.org
Cancer and Blood Specialists-Shadow
Contact: Site Public Contact
Email: research@sncrf.org
Cancer and Blood Specialists-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Summerlin
Contact: Site Public Contact
Email: research@sncrf.org
Desert West Surgery
Contact: Site Public Contact
Email: research@sncrf.org
GenesisCare USA - Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org
GenesisCare USA - Las Vegas
Contact: Site Public Contact
Email: research@sncrf.org
GenesisCare USA - Vegas Tenaya
Contact: Site Public Contact
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Contact: Site Public Contact
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Contact: Site Public Contact
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Contact: Site Public Contact
Email: research@sncrf.org
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org
Hope Cancer Care of Nevada
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Cancer Center-Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Prostate Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Urology - Cathedral Rock
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Urology - Pecos
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas Urology - Smoke Ranch
Contact: Site Public Contact
Email: research@smcrf.org
Las Vegas Urology - Sunset
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at MountainView
Contact: Site Public Contact
Email: research@sncrf.org
Radiation Oncology Centers of Nevada Central
Contact: Site Public Contact
Email: research@sncrf.org
Radiation Oncology Centers of Nevada Southeast
Contact: Site Public Contact
Email: research@sncrf.org
Summerlin Hospital Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
Sunrise Hospital and Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
University Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org
University Medical Center of Southern Nevada
Contact: Site Public Contact
Email: research@sncrf.org
Urology Specialists of Nevada - Central
Contact: Site Public Contact
Email: research@sncrf.org
Urology Specialists of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org
Urology Specialists of Nevada - Southwest
Contact: Site Public Contact
Email: research@sncrf.org
Pahrump
Hope Cancer Care of Nevada-Pahrump
Contact: Site Public Contact
Email: research@sncrf.org
Reno
Radiation Oncology Associates
Contact: Site Public Contact
Email: research@sncrf.org
Renown Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
Saint Mary's Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
NY
Albany
Albany Medical Center
Contact: Site Public Contact
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact
Mount Sinai Hospital
Contact: Site Public Contact
Email: CCTO@mssm.edu
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@cumc.columbia.edu
NYP/Weill Cornell Medical Center
Contact: Site Public Contact
Stony Brook
Stony Brook University Medical Center
Contact: Site Public Contact
Syracuse
State University of New York Upstate Medical University
Contact: Site Public Contact
OH
Akron
Children's Hospital Medical Center of Akron
Contact: Site Public Contact
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Cincinnati Children's Hospital Medical Center
Contact: Site Public Contact
Email: cancer@cchmc.org
Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Cleveland
MetroHealth Medical Center
Contact: Site Public Contact
Email: ababal@metrohealth.org
Columbus
Nationwide Children's Hospital
Contact: Site Public Contact
Email: Melinda.Triplet@nationwidechildrens.org
OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Contact: Site Public Contact
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Contact: Site Public Contact
OR
Baker City
Saint Alphonsus Cancer Care Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Ontario
Saint Alphonsus Cancer Care Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact
PA
Hershey
Penn State Milton S Hershey Medical Center
Contact: Site Public Contact
Email: CTO@hmc.psu.edu
Philadelphia
Children's Hospital of Philadelphia
Contact: Site Public Contact
Email: CancerTrials@email.chop.edu
Fox Chase Cancer Center
Contact: Site Public Contact
University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact
Email: PennCancerTrials@careboxhealth.com
SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact
Columbia
Prisma Health Richland Hospital
Contact: Site Public Contact
Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org
Greenville
BI-LO Charities Children's Cancer Center
Contact: Site Public Contact
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact
Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact
Prisma Health Cancer Institute - Faris
Contact: Site Public Contact
Prisma Health Greenville Memorial Hospital
Contact: Site Public Contact
Saint Francis Cancer Center
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org
Saint Francis Hospital
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org
Greer
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact
Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact
TN
Chattanooga
Memorial Hospital
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Knoxville
East Tennessee Childrens Hospital
Contact: Site Public Contact
Memphis
Saint Jude Children's Research Hospital
Contact: Site Public Contact
Email: referralinfo@stjude.org
Nashville
The Children's Hospital at TriStar Centennial
Contact: Site Public Contact
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact
Ooltewah
Memorial GYN Plus
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
TX
Austin
Dell Children's Medical Center of Central Texas
Contact: Site Public Contact
Email: TXAUS-DL-SFCHemonc.research@ascension.org
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Corpus Christi
Driscoll Children's Hospital
Contact: Site Public Contact
Email: Crystal.DeLosSantos@dchstx.org
El Paso
El Paso Children's Hospital
Contact: Site Public Contact
Email: ranjan.bista@ttuhsc.edu
Fort Worth
Cook Children's Medical Center
Contact: Site Public Contact
Email: CookChildrensResearch@cookchildrens.org
San Antonio
Children's Hospital of San Antonio
Contact: Site Public Contact
Email: bridget.medina@christushealth.org
UT
American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Contact: Site Public Contact
Email: officeofresearch@imail.org
Cedar City
Sandra L Maxwell Cancer Center
Contact: Site Public Contact
Email: officeofresearch@imail.org
Logan
Logan Regional Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org
Murray
Intermountain Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org
Ogden
McKay-Dee Hospital Center
Contact: Site Public Contact
Email: officeofresearch@imail.org
Riverton
Riverton Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org
Saint George
Saint George Regional Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org
Salt Lake City
LDS Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org
Utah Cancer Specialists-Salt Lake City
Contact: Site Public Contact
Email: officeofresearch@imail.org
VA
Norfolk
Children's Hospital of The King's Daughters
Contact: Site Public Contact
Email: CCBDCresearch@chkd.org
WA
Aberdeen
Providence Regional Cancer System-Aberdeen
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Auburn
MultiCare Auburn Medical Center
Contact: Site Public Contact
Email: research@multicare.org
Bellevue
Overlake Medical Center
Contact: Site Public Contact
Email: OHMCResearch@overlakehospital.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Contact: Site Public Contact
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Centralia
Providence Regional Cancer System-Centralia
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Enumclaw
Saint Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Everett
Providence Regional Cancer Partnership
Contact: Site Public Contact
Email: marilyn.birchman@providence.org
Federal Way
Saint Francis Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Gig Harbor
MultiCare Gig Harbor Medical Park
Contact: Site Public Contact
Email: research@multicare.org
Issaquah
Swedish Cancer Institute-Issaquah
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Contact: Site Public Contact
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Lakewood
Saint Clare Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Longview
PeaceHealth Saint John Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Port Townsend
Jefferson Healthcare
Contact: Site Public Contact
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Puyallup
MultiCare Good Samaritan Hospital
Contact: Site Public Contact
Email: research@multicare.org
Renton
Valley Medical Center
Contact: Site Public Contact
Email: research@valleymed.org
Seattle
Kaiser Permanente Washington
Contact: Site Public Contact
Email: KPWAoncologytrials@kp.org
Pacific Gynecology Specialists
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Seattle Children's Hospital
Contact: Site Public Contact
Swedish Medical Center-Ballard Campus
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Sedro-Woolley
PeaceHealth United General Medical Center
Contact: Site Public Contact
Email: lkey@peacehealth.org
Shelton
Providence Regional Cancer System-Shelton
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Silverdale
Saint Michael Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Contact: Site Public Contact
Email: research@multicare.org
MultiCare Deaconess Cancer and Blood Specialty Center - North
Contact: Site Public Contact
Email: research@multicare.org
Providence Sacred Heart Medical Center and Children's Hospital
Contact: Site Public Contact
Email: HopeBeginsHere@providence.org
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Contact: Site Public Contact
Email: research@multicare.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Madigan Army Medical Center
Contact: Site Public Contact
Email: melissa.a.forouhar.mil@health.mil
Mary Bridge Children's Hospital and Health Center
Contact: Site Public Contact
Email: research@multicare.org
MultiCare Tacoma General Hospital
Contact: Site Public Contact
Email: research@multicare.org
Northwest Medical Specialties PLLC
Contact: Site Public Contact
Email: research@southsoundcare.org
Vancouver
PeaceHealth Southwest Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Contact: Site Public Contact
Email: Cheryl.Dodd@providence.org
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Contact: Site Public Contact
Email: Memorial-ClinicalTrials@yvmh.org
Yelm
Providence Regional Cancer System-Yelm
Contact: Site Public Contact
Email: deidre.dillon@providence.org
WI
Ashland
Duluth Clinic Ashland
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Northwest Wisconsin Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org
Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Contact: Site Public Contact
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org
La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org
Ladysmith
Marshfield Medical Center - Ladysmith
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org
Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Medical College of Wisconsin
Contact: Site Public Contact
Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org
Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org
Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
WV
Bridgeport
United Hospital Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
Martinsburg
WVUH-Berkely Medical Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
Parkersburg
Camden Clark Medical Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org
Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
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 of cycles 1-16 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. All patients also undergo computed tomography (CT) or positron emission tomography (PET) scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study. 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 10 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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