Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01134614
First received: April 27, 2010
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Colony-stimulating factors, such as sargramostim (GM-CSF), may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet know whether giving ipilimumab together with GM-CSF is more effective than ipilimumab alone in treating melanoma.


Condition Intervention Phase
Recurrent Melanoma
Stage III Melanoma
Stage IV Melanoma
Biological: ipilimumab
Biological: sargramostim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The method of Kaplan- Meir will be used.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to disease progression or death without progression, assessed up to 5 years ] [ Designated as safety issue: No ]
    The method of Kaplan- Meir will be used.

  • Response rate using RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The Kappa statistics which measures the degree of agreement between the RECIST-based response and irRC will be estimated. McNemar's test will be used to evaluate the agreement between irRC and RECIST-based clinical response.

  • Safety and tolerability assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Incidence data of specific toxicity type as well overall worst degree toxicity data will be summarized and compared between the two arms.


Estimated Enrollment: 220
Study Start Date: December 2010
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (ipilimumab and sargramostim)
Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment repeats every 21 days for 4 courses. Patients with responsive or stable disease then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Biological: ipilimumab
Given IV
Other Names:
  • anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4
Biological: sargramostim
Given SC
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
Experimental: Arm II (ipilimumab)
Patients receive induction therapy comprising ipilimumab as in arm I. Patients with responsive or stable disease then receive maintenance therapy comprising ipilimumab IV as in arm I. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Biological: ipilimumab
Given IV
Other Names:
  • anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the overall survival of patients with advanced melanoma treated with ipilimumab with versus without sargramostim.

SECONDARY OBJECTIVES:

I. To evaluate the progression-free survival of patients treated with these regimens.

II. To evaluate the response rate in patients treated with these regimens. III. To evaluate the safety and tolerability of these regimens in these patients.

IV. To explore prospectively the utility of immune-related response criteria (irRC) of patients receiving ipilimumab.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (unresectable vs M1a/1b vs M1c) and prior therapy (none vs interferon vs one investigational therapy). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 courses. Patients with responsive or stable disease then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive induction therapy comprising ipilimumab as in arm I. Patients with responsive or stable disease then receive maintenance therapy comprising ipilimumab IV as in arm I. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3-6 months for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic melanoma

    • Unresectable stage III or IV disease
    • For unknown primary disease, diagnosis of metastatic disease by cytology FNA is not acceptable
  • Measurable disease
  • No more than 1 prior investigational therapy or systemic therapeutic regimen*, including any of the following:

    • Chemotherapy
    • Biological therapy
    • Biochemotherapy
    • Investigational treatment
  • No CNS metastases
  • ECOG performance status 0-1
  • WBC ≥ 2,000/μL
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 8 g/dL
  • Creatinine ≤ 3.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Bilirubin ≤ 3.0 times ULN (total bilirubin < 3.0 mg/dL for patients with Gilbert syndrome)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 12 weeks after completion of study
  • No HIV infection
  • No active infection with hepatitis B virus
  • No active or chronic infection with hepatitis C virus
  • No other malignancy with the past 2 years except adequately treated and cured basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  • No history of autoimmune disease, including any of the following:

    • Inflammatory bowel disease
    • Symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis[scleroderma])
    • Systemic lupus erythematosus
    • Autoimmune vasculitis (e.g., Wegener granulomatosis)
    • Motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis)
  • Patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
  • No underlying medical or psychiatric condition that, in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
  • No concurrent medical condition requiring the use of systemic steroids
  • No other concurrent CTLA-4 inhibitor or agonist or CD137 agonist
  • At least 4 weeks since prior and no concurrent therapy with any of the following:

    • Aldesleukin (IL-2)
    • Interferon
    • Non-study immunotherapy regimens
    • Cytotoxic chemotherapy
    • Immunosuppressive agents
    • Other investigational therapies
    • Chronic use of systemic corticosteroids

      • Concurrent inhaled or topical steroids allowed
      • Concurrent physiologic replacement doses of corticosteroids allowed
  • No prior non-oncology vaccine therapy for the prevention of infectious disease within the past 28 days or after any dose of ipilimumab
  • No prior ipilimumab, CD137agonist, or CTLA-4 inhibitor or agonist
  • No other systemic or local anticancer medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134614

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80110
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520-8032
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Cancer Specialists of North Florida-Orange Park
Orange Park, Florida, United States, 32073
United States, Georgia
Northeast Georgia Cancer Care LLC
Athens, Georgia, United States, 30607
Emory University
Atlanta, Georgia, United States, 30322
Georgia Regents University
Augusta, Georgia, United States, 30912
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Hematology Oncology Associates-Berwyn
Berwyn, Illinois, United States, 60402
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Trinity Medical Center
Moline, Illinois, United States, 61265
DuPage Medical Group-Ogden
Naperville, Illinois, United States, 60563
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Foundation - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Center
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50314
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Ochsner North Shore Medical Center
Covington, Louisiana, United States, 70433
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Nevada
Nevada Cancer Institute-Summerlin Campus
Las Vegas, Nevada, United States, 89135
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Hackensack University Medical CCOP
Hackensack, New Jersey, United States, 07601
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
New York Oncology Hematology PC -Albany Medical Center
Albany, New York, United States, 12208
Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
New York University Langone Medical Center
New York, New York, United States, 10016
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Ohio
Summa Akron City Hospital
Akron, Ohio, United States, 44304
Mercy Medical Center
Canton, Ohio, United States, 44708
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Flower Hospital
Sylvania, Ohio, United States, 43560
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Saint Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Dakota
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Mercy Health System
Janesville, Wisconsin, United States, 53547
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic
Two Rivers, Wisconsin, United States, 54241
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Investigators
Principal Investigator: Frank Hodi Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01134614     History of Changes
Other Study ID Numbers: NCI-2011-02039, NCI-2011-02039, CDR0000671238, E1608, E1608, U10CA021115
Study First Received: April 27, 2010
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014