Ipilimumab with or without Bevacizumab in Treating Patients with Stage III-IV Melanoma That Cannot Be Removed by Surgery

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overE3612
NCI-2013-01732, ECOG-E3612, NCT01950390

Trial Description

Summary

This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and bevacizumab, block tumor growth in different ways by targeting certain cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To compare overall survival for patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

SECONDARY OBJECTIVES:

I. To evaluate the progression free survival, response rate and safety in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

II. To evaluate the utility of immune related response criteria (irRC) in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A:

INDUCTION THERAPY: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning course 8, patients receive ipilimumab IV over 90 minutes on day 1. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM B:

INDUCTION THERAPY: Patients receive ipilimumab IV over 90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive bevacizumab as in Induction Therapy. Beginning course 8, patients also receive ipilimumab IV over 90 minutes on day 1. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

Untreated or previously received one treatment for measurable unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] 2010) (regardless of v-raf murine sarcoma viral oncogene homolog B [BRAF] mutation status or human leukocyte antigen [HLA] type); this does not include any therapies given in the adjuvant setting

Prior treatment (chemotherapy [chemo], radiation, hormone, and immune therapies) must be completed > 4 weeks prior to randomization (> 6 weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors)

Patients who received prior therapy with anthracyclines should have a baseline multigated acquisition scan (MUGA) or echocardiogram (echo) with a normal ejection fraction within 28 days prior to randomization

Patients must have recovered from any acute toxicity associated with prior therapy by the start of study treatment

Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease

White blood cell (WBC) >= 2000/uL

Absolute neutrophil count (ANC) >= 1000/uL

Platelets >= 75 x 10^3/uL

Hemoglobin >= 9 g/dL

Creatinine =< 2.0 x upper limit of normal (ULN)

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN for patients without liver metastases and =< 5 x ULN for patients with liver metastases

Serum bilirubin =< 2.0 x ULN (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)

Patients BRAF mutation status must be known

No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks prior to randomization

No infection with human immunodeficiency virus (HIV)

No active infection with hepatitis B

No active or chronic infection with hepatitis C

Patients are ineligible if they have any history of central nervous system (CNS) metastases

Patients are ineligible if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix

Patients are ineligible if they have a history of autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy

Patients are ineligible if they have an active infection

Patients are ineligible if they have a history of prior treatment with ipilimumab, bevacizumab, or prior tumor necrosis factor receptor superfamily, member 9 (CD137) agonist or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or agonist; patients may be treatment naïve or have had one prior systemic therapy for metastatic disease as outlined in the eligibility criteria; patients may have received prior anti-programmed cell death (PD)-1 or anti-programmed cell death ligand (PD-L)1 as per current protocol eligibility, although they are not currently commercially approved in the front line setting

Patients are ineligible if they have a history of any underlying medical or psychiatric conditions or require any medications or treatment that in the opinion of the principal investigator may interfere with compliance, make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea

Patients are ineligible if they have any concurrent medical condition requiring the use of systemic steroids; (use of inhaled or topical steroids is acceptable)

Patients are ineligible if they have inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)

Patients are excluded if they have any prior history of hypertensive crisis or hypertensive encephalopathy

Patients are excluded if they have New York Heart Association (NYHA) grade II or greater congestive heart failure

Patients are excluded if they have a history of myocardial infarction or unstable angina within 6 months prior to randomization

Patients are excluded if they have a history of stroke or transient ischemic attack within 6 months prior to randomization

Patients are excluded if they have known significant vascular disease (e.g., aortic aneurysm, aortic dissection)

Patients are excluded if they have symptomatic peripheral vascular disease

Patients are excluded if they have evidence of bleeding diathesis or coagulopathy

Patients are excluded if they have had a surgical procedure or a significant traumatic injury within 28 days prior to randomization

Patients are excluded if they have had a biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to randomization

Patients are excluded if they have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization

Patients are excluded if they have a non-healing wound or ulcer

Patients are excluded if they have proteinuria at screening as demonstrated by either:

Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1 g of protein in 24 hours to be eligible) OR

Urine protein: creatinine (UPC) ratio >= 1.0 at screening; for UPC ratio > 1, a 24 hour urine protein should be obtained and the level should be < 1000mg; NOTE: urine protein should be screened by urine analysis for UPC ratio; a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 g

Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

Patients are excluded if they have a history of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3 months prior to randomization

Patients are excluded if they have current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin); subjects should have not taken full-dose warfarin or equivalent for at least 2 weeks prior to randomization

Patients are excluded if they have current or recent (within 10 days of enrollment) use of aspirin (> 325 mg/day) or chronic use of other non-steroidal anti-inflammatory drugs (NSAID)

Patients are excluded if they use medications that inhibit platelet function (e.g., dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and ibuprofen and related compounds) unless subject has been off treatment for at least 2 weeks prior to randomization

Patients are excluded if they have known involvement of melanoma within the gastrointestinal tract

Patients are excluded for any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)

Women of childbearing potential and sexually active males must agree to practice abstinence or use an accepted and effective method of contraception

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Frank Stephen Hodi, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

University of Alabama at Birmingham Cancer Center

Robert Martin Conry
Ph: 205-978-0250
Email: rconry@uabmc.edu

Robert Martin Conry
Principal Investigator

Mobile

University of South Alabama Mitchell Cancer Institute

Thomas Wayne Butler
Ph: 251-445-9870
Email: pfrancisco@usouthal.edu

Thomas Wayne Butler
Principal Investigator

Delaware
Lewes

Beebe Medical Center

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Newark

Christiana Care Health System-Christiana Hospital

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Christiana Gynecologic Oncology LLC

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Delaware Clinical and Laboratory Physicians PA

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Helen F Graham Cancer Center

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Medical Oncology Hematology Consultants PA

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Regional Hematology and Oncology PA

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Rehoboth Beach

Beebe Health Campus

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Seaford

Nanticoke Memorial Hospital

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Wilmington

Christiana Care Health System-Wilmington Hospital

Gregory Andrew Masters
Ph: 302-733-6227
Email: gmasters@cbg.org

Gregory Andrew Masters
Principal Investigator

Georgia
Savannah

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Howard A. Zaren
Ph: 800-622-6877
Email: drzaren@sjchs.org

Howard A. Zaren
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Illinois
Chicago

Saint Joseph Hospital

Ira Anton Oliff
Ph: 224-534-7580
Email: ira.oliff@orchardhr.com

Ira Anton Oliff
Principal Investigator

Galesburg

Illinois CancerCare-Galesburg Cottage Plaza Office

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Joliet

Joliet Oncology-Hematology Associates Limited

Jason Jung-Gon Suh
Ph: 815-730-3098
Email: maureenc@jolietoncology.com

Jason Jung-Gon Suh
Principal Investigator

Rockford

SwedishAmerican Regional Cancer Center/ACT

Harvey E. Einhorn
Ph: 779-696-9400
Email: cancercare@swedishamerican.org

Harvey E. Einhorn
Principal Investigator

Iowa
Ames

Mary Greeley Medical Center

Joseph James Merchant
Ph: 515-239-4791
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-4791
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

Boone

McFarland Clinic PC-Boone

Joseph James Merchant
Ph: 515-239-4791
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

Fort Dodge

McFarland Clinic PC-Trinity Cancer Center

Joseph James Merchant
Ph: 515-239-4791
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

Jefferson

McFarland Clinic PC-Jefferson

Joseph James Merchant
Ph: 515-239-4791
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

Marshalltown

McFarland Clinic PC-Marshalltown

Joseph James Merchant
Ph: 515-239-4791
Email: jjmerchant@mcfarlandclinic.com

Joseph James Merchant
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088
Email: drednew@msn.com

Donald B. Wender
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Main Office

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-262-4467
Email: shaker.dakhil@cancercenterofkansas.com

Shaker R. Dakhil
Principal Investigator

Kentucky
Louisville

The James Graham Brown Cancer Center at University of Louisville

Donald M. Miller
Ph: 502-562-3462
Email: donaldmi@ulh.org

Donald M. Miller
Principal Investigator

Maine
Augusta

Harold Alfond Center for Cancer Care

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Bangor

Eastern Maine Medical Center

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Brewer

Lafayette Family Cancer Center-EMMC

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Rockport

Penobscot Bay Medical Center

Thomas H. Openshaw
Ph: 207-973-7807
Email: topenshaw@emh.org

Thomas H. Openshaw
Principal Investigator

Massachusetts
Springfield

Baystate Medical Center

John Charles McCann
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

John Charles McCann
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Battle Creek

Bronson Battle Creek

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Dearborn

Oakwood Hospital and Medical Center

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Flint

Genesys Hurley Cancer Institute

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Hurley Medical Center

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Grand Rapids

Mercy Health Saint Mary's

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Spectrum Health at Butterworth Campus

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Jackson

Allegiance Health

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Kalamazoo

Borgess Medical Center

Sunil Nagpal
Ph: 269-373-7458
Email: snagpal@wmcc.org

Sunil Nagpal
Principal Investigator

Bronson Methodist Hospital

Sunil Nagpal
Ph: 269-373-7458
Email: snagpal@wmcc.org

Sunil Nagpal
Principal Investigator

Lansing

Sparrow Hospital

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Muskegon

Mercy Health Mercy Campus

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Niles

Lakeland Community Hospital

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Pontiac

Saint Joseph Mercy Oakland

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Reed City

Spectrum Health Reed City Hospital

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Saginaw

Saint Mary's of Michigan

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Saint Joseph

Marie Yeager Cancer Center

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

St. Joseph

Lakeland Hospital

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Traverse City

Munson Medical Center

Kathleen J. Yost
Ph: 616-391-1230
Email: connie.szczepanek@grcop.org

Kathleen J. Yost
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Tareq Al Baghdadi
Ph: 734-712-1012
Email: tareq_albaghdadi@ihacares.com

Tareq Al Baghdadi
Principal Investigator

Montana
Anaconda

Community Hospital of Anaconda

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Vincent Healthcare

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Butte

Saint James Community Hospital and Cancer Treatment Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Great Falls Clinic

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Saint Patrick Hospital - Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Nebraska
Lincoln

Nebraska Cancer Research Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Nebraska Hematology and Oncology

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Southeast Nebraska Cancer Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Norfolk

Faith Regional Medical Offices West

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

North Platte

Great Plains Regional Medical Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Omaha

Missouri Valley Cancer Consortium

Gamini S. Soori
Ph: 402-991-8070ext202
Email: mwilwerding@mvcc.cc

Gamini S. Soori
Principal Investigator

Oncology Hematology West

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Oncology Hematology West PC

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Scottsbluff

Regional West Medical Center

Gamini S. Soori
Ph: 402-991-8070
Email: gsoori@mvcc.cc

Gamini S. Soori
Principal Investigator

Nevada
Henderson

21st Century Oncology - Henderson

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Henderson

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Henderson

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Southeast Henderson

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Henderson

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Las Vegas

21st Century Oncology

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

21st Century Oncology - Fort Apache

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

21st Century Oncology - Vegas Tenaya

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Fort Apache

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Shadow

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Tenaya

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Cancer Therapy and Integrative Medicine

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Central Valley

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Northwest

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Summerlin

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-San Martin

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Medical Center

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Central

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Southeast

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

University Medical Center of Southern Nevada

John Allan Ellerton
Ph: 702-384-0013
Email: j.ellerton@sncrf.org

John Allan Ellerton
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical CCOP

Donna Trauth McNamara
Ph: 201-996-2879

Donna Trauth McNamara
Principal Investigator

Vineland

Inspira Medical Center Vineland

Benjamin P. Negin
Ph: 856-691-1686
Email: bnegin@gmail.com

Benjamin P. Negin
Principal Investigator

Woodbury

Inspira Medical Center Woodbury

Tami Lee Bach
Ph: 856-423-7508
Email: tami.bach@comcast.net

Tami Lee Bach
Principal Investigator

New York
White Plains

Dickstein Cancer Treatment Center

Dan Costin
Ph: 914-681-2290
Email: dcostin@wphospital.org

Dan Costin
Principal Investigator

North Carolina
Hendersonville

Hendersonville Hematology and Oncology at Pardee

James Earl Radford
Ph: 828-696-4716
Email: james.radford@pardeehospital.org

James Earl Radford
Principal Investigator

Margaret R Pardee Memorial Hospital

James Earl Radford
Ph: 828-696-4716
Email: james.radford@pardeehospital.org

James Earl Radford
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

North Dakota
Grand Forks

Altru Cancer Center

Grant Richard Seeger
Ph: 701-780-6520
Email: gseeger@altru.org

Grant Richard Seeger
Principal Investigator

Ohio
Belpre

Strecker Cancer Center-Belpre

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Chillicothe

Adena Regional Medical Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Columbus

Columbus Oncology and Hematology Associates Inc

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Doctors Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Grant Medical Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Mount Carmel East Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Mount Carmel Health Center West

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Riverside Methodist Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

The Mark H Zangmeister Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Delaware

Delaware Health Center-Grady Cancer Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Marion

OneHealth Marion General Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Mount Vernon

Knox Community Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Portsmouth

Southern Ohio Medical Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Westerville

Saint Ann's Hospital

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Zanesville

Genesis Healthcare System Cancer Care Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Alexandra P. Ikeguchi
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Alexandra P. Ikeguchi
Principal Investigator

Tulsa

Oklahoma Cancer Specialists and Research Institute-Tulsa

Alexandra P. Ikeguchi
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Alexandra P. Ikeguchi
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Willard G. Andrews
Ph: 215-481-2402
Email: wandrews@amh.org

Willard G. Andrews
Principal Investigator

Danville

Geisinger Medical Center

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

Hershey

Penn State Hershey Cancer Institute-Clinical Trials Office

Joseph John Drabick
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

Joseph John Drabick
Principal Investigator

Lewisburg

Geisinger Medical Oncology-Lewisburg

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

Lewistown

Lewistown Hospital

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

Pittsburgh

University of Pittsburgh Cancer Institute (UPCI)

Ahmad A. Tarhini
Ph: 412-647-8073
Email: tarhiniaa@upmc.edu

Ahmad A. Tarhini
Principal Investigator

Pottsville

Geisinger Medical Oncology-Pottsville

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

Scranton

Scranton Hematology Oncology

Martin Hyzinski
Ph: 570-558-3020
Email: martin_hyzinski@chs.net

Martin Hyzinski
Principal Investigator

State College

Geisinger Medical Group

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

West Reading

Reading Hospital

Terrence Paul Cescon
Ph: 484-628-0901
Email: terrence.cescon@readinghealth.org

Terrence Paul Cescon
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Christian S. Adonizio
Ph: 570-271-5251
Email: csadonizio@geisinger.edu

Christian S. Adonizio
Principal Investigator

South Carolina
Easley

Greenville Health System Cancer Institute-Easley

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Butternut

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Greenville Health System Cancer Institute-Eastside

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Greenville Health System Cancer Institute-Faris

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Greenville Memorial Hospital

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

Jeffrey K. Giguere
Ph: 864-241-6251
Email: jgiguere@ghs.org

Jeffrey K. Giguere
Principal Investigator

South Dakota
Rapid City

Rapid City Regional Hospital

Joshua Cole Lukenbill
Ph: 605-716-3982
Email: research@rcrh.org

Joshua Cole Lukenbill
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

Inderjit Mehmi
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Inderjit Mehmi
Principal Investigator

Wisconsin
Green Bay

Bellin Memorial Hospital

Patrick J. Mansky
Ph: 240-566-3584
Email: clinicaltrials@fmh.org

Patrick J. Mansky
Principal Investigator

Johnson Creek

UW Cancer Center Johnson Creek

Mark Richard Albertini
Ph: 877-405-6866
Email: mralbert@wisc.edu

Mark Richard Albertini
Principal Investigator

Milwaukee

Froedtert and the Medical College of Wisconsin

Stuart J. Wong
Ph: 414-805-4380
Email: swong@mcw.edu

Stuart J. Wong
Principal Investigator

Wyoming
Cody

Big Horn Basin Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Billings Clinic-Cody

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274
Email: bmarchello@mtcancer.org

Benjamin T. Marchello
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01950390

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.