Melanoma Clinical Trial

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

Summary

The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

View Full Description

Full Description

Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosed with malignant melanoma
Measurable unresectable Stage III or IV melanoma
HLA-A*0201 positive
Previous treatment with & failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide
At least 4 weeks since prior treatment
Negative pregnancy
Life expectancy greater than 4 months
Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
Required lab values
Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) negative

Exclusion Criteria:

Prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer
Ocular melanoma
Active, untreated central nervous system (CNS) metastasis
Prior treatment with MDX-010 (anti-CTLA4) antibody
Prior treatment with any cancer therapeutic vaccine
Active autoimmune disease or history of autoimmune disease
Pregnancy or nursing
Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)
Underlying medical conditions deemed hazardous if treated with study drug
Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids
Unable to provide informed consent

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1783

Study ID:

NCT00094653

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 166 Locations for this study

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Arizona Cancer Center
Tucson Arizona, 85724, United States
University Medical Center
Tucson Arizona, 85724, United States
City of Hope National Medical Center
Duarte California, 91010, United States
San Diego Cancer Center
Encinitas California, 92024, United States
La Jolla Hematology and Oncology Medical Group
La Jolla California, 92037, United States
Scripps Cancer Center
La Jolla California, 92037, United States
Moores UCSD Cancer Center
La Jolla California, 92093, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Cancer Institute Medical Group, Inc
Los Angeles California, 90025, United States
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
North County Oncology Medical Clinical, Inc.
Oceanside California, 92056, United States
City of Hope Medical Group
Pasadena California, 91105, United States
University of California, San Diego
San Diego California, 92103, United States
St. Mary's Medical Center - Northern California Melanoma Center
San Francisco California, 94109, United States
Cancer Institute Medical Group, Inc
Santa Monica California, 90404, United States
San Diego Cancer Center
Vista California, 92081, United States
Anschutz Cancer Pavilion
Aurora Colorado, 80010, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
University of Colorado Health Sciences Center
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Centers
Boulder Colorado, 80304, United States
Rocky Mountain Cancer Centers
Colorado Springs Colorado, 80909, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
University of Colorado Hospital
Denver Colorado, 80262, United States
Rocky Mountain Cancer Centers
Lakewood Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton Colorado, 80120, United States
Rocky Mountain Cancer Centers
Lone Tree Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont Colorado, 80501, United States
Yale University School of Medicine - Oncology Outpatient Clinic
New Haven Connecticut, 06520, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura Florida, 33180, United States
Memorial Regional Cancer Center
Hollywood Florida, 33021, United States
Shands Jacksonville
Jacksonville Florida, 32209, United States
University of Florida/Jacksonville Faculty Clinic
Jacksonville Florida, 32209, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Jackson Memorial Hospital & Clinics
Miami Florida, 33136, United States
University of Miami Hospital & Clinics
Miami Florida, 33136, United States
M.D. Anderson Cancer Center Orlando
Orlando Florida, 32806, United States
Palm Beach Cancer Institute
Palm Beach Gardens Florida, 33410, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Palm Beach Cancer Institute
Wellington Florida, 33414, United States
Palm Beach Cancer Institute
West Palm Beach Florida, 33401, United States
Emory University Hospital-Winship Cancer Institute
Atlanta Georgia, 30322, United States
Cancer Care Specialists of Central IL
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Cancer Care Specialists of Central IL
Effingham Illinois, 62401, United States
Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
Maywood Illinois, 60153, United States
Center for Cancer Care at Goshen Health System
Goshen Indiana, 46526, United States
Indiana Oncology Hematology Consultants North
Indianapolis Indiana, 46202, United States
American Health Network of IN, LLC
Indianapolis Indiana, 46237, United States
Indiana Oncology Hematology South
Indianapolis Indiana, 46237, United States
Indiana Oncology Hematology Consutants of Noblesville
Noblesville Indiana, 46060, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Norton Hospital
Louisville Kentucky, 40202, United States
University of Louisville Hospital
Louisville Kentucky, 40202, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lutherville Maryland, 21093, United States
Beth Isreal Dec Medical Center
Boston Massachusetts, 02115, United States
Brigham and Womens Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Henry Ford Medical Center
Dearborn Michigan, 48126, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Henry Ford Medical Center- West Bloomfield
West Bloomfield Michigan, 48322, United States
Humphrey Cancer Center
Coon Rapids Minnesota, 55433, United States
Humphrey Cancer Center
Fridley Minnesota, 55432, United States
Hubert H Humphrey Cancer Center
Robbinsdale Minnesota, 55422, United States
Family Cancer Center
Olive Branch Mississippi, 38654, United States
Ellis Fischel Cancer Center
Columbia Missouri, 65203, United States
St. Joseph Oncology, Inc
St. Joseph Missouri, 64507, United States
Barnes Jewish Hospital
St. Louis Missouri, 63110, United States
Washington Unv. School of Med./ Siteman Cancer Center
St. Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
The Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown New Jersey, 07962, United States
Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08901, United States
The Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Overlook Oncology Center
Summit New Jersey, 07901, United States
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque New Mexico, 87109, United States
Hematology-Oncology Associates of CNY
East Syracuse New York, 13057, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Columbia University Medical Center, Irving Center for Clinical Research
New York New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
The Christ Hospital Cancer Center
Cincinnati Ohio, 45219, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
The Oregon Clinical
Portland Oregon, 97213, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Thomas Jefferson University Hosptital
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Hillman Cancer Research Pavilion
Pittsburgh Pennsylvania, 15213, United States
Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15232, United States
Cancer Centers of the Carolinas
Easley South Carolina, 29640, United States
Cancer Centers of the Carolinas
Greenville South Carolina, 29615, United States
Cancer Centers of the Carolinas
Seneca South Carolina, 29672, United States
Cancer Centers of the Carolinas
Spartanburg South Carolina, 29307, United States
Family Cancer Center
Bartlett Tennessee, 38133, United States
Family Cancer Center
Collierville Tennessee, 38017, United States
Family Cancer Center
Memphis Tennessee, 38119, United States
The West Clinic
Memphis Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Arlington Cancer Center
Arlington Texas, 76012, United States
Center for Oncology Research and Treatment
Dallas Texas, 75230, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Center for Oncology Research and Treatment
Richardson Texas, 75080, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Fletcher Allen Health Care
Burlington Vermont, 05405, United States
Hospital Municipal de Oncoligia Maria Curie
Ciudad de Buenos Aires Buenos Aires, , Argentina
Instituto Medico Platense
La Plata Provincia de Buenos Aires, 1900, Argentina
Hospital Militar Central
Buenos Aires , , Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires , , Argentina
Hospital Britanico de Buenos Aires
Ciudad de Buenos Aires , C1280, Argentina
Hospital Municipal de Oncologia Maria Curie
Ciudad de Buenos Aires , C1405, Argentina
Hospital General de Agudos Carlos G. Durand
Ciudad de Buenos Aires , C1405, Argentina
Instituto de Oncologia Angel H. Roffo
Ciudad de Buenos Aires , C1417, Argentina
Hospital Militar Central
Ciudad de Buenos Aires , C1426, Argentina
Instituto Alexander Fleming
Ciudad de Buenos Aires , C1426, Argentina
Hospital Privado de Cordoba S.A.
Cordoba , X5016, Argentina
Hospital Privado Centro Medico de Cordoba S.A.
Cordoba , , Argentina
ISIS Clinica Especializada
Santa Fe , S3000, Argentina
ISIS Clinica Especializada
Santa Fe , , Argentina
Institut Jules Bordet
Brussels , 1000, Belgium
Erasme Hospital, Free Universtiy of Brussels
Brussels , 1070, Belgium
Erasme Hospital
Brussels , 1070, Belgium
U.Z. Gent
Gent , 9000, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven , 3000, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir , 5530, Belgium
Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
Goiania GO, , Brazil
Pro Onco Centro Tratamento Oncologico
Londrina PR, , Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre RS, , Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos SP, , Brazil
Fundacoa Hospital Amaral Carvalho
Jau SP, , Brazil
Santo Andre Diagnosticos aTratamentos
Santo Andre SP, , Brazil
Sociedade Beneficante de Sennores - Hospital Sino Libante
Sao Paulo SP, , Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos - SP , 14784, Brazil
Biocor - Hosp. de Doencas Cardiovasculares Ltda.
Belo Horizonte - MG , 34000, Brazil
Hospital Araujo Jorge
Goiania - GO , 74605, Brazil
Pro Onco Centro Tratemento Oncologico
Londrina - PR , 86050, Brazil
Fund. SOAD / HC de Porto Alegre
Porto Alegre - RS , 90035, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre - RS , 90610, Brazil
Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
Porto Alegre , 90035, Brazil
Santo Andre Diagnosticos e Tratamentos Ltda.
Santo Andre-SP , 09090, Brazil
HC-FMUSP
Sao Paulo - SP , 05403, Brazil
Hospital Sirio Labanes
Sao Paulo-SP , 01308, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's Newfoundland and Labrador, A1B 3, Canada
Cancer Centre of Southeastern Ontario at KGH
Kingston Ontario, K7L 5, Canada
London Regional Cancer Program
London Ontario, N6A 4, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Instituto Nacional del Cancer
Independencia Santiago, , Chile
Clinica Davila
Recoleta Santiago, , Chile
Clinica Renaca
Renaca Vina Del Mar, , Chile
Fundacion Arturo Lopez Perez
Santiago , , Chile
Hospital Barros Luco
Santiago , , Chile
Centre Oscar Lambret
Lille , 59020, France
Centre Leon Berard
Lyon , 69373, France
Hopital Sainte-Marguerite
Marseille , 13009, France
Hopital Saint-Eloi
Montpellier , 34295, France
Hotel Dieu
Nantes , 44093, France
Centre Antoine Lacassagne
Nice cedex 2 , 06189, France
Hopital Saint-Louis
Paris , 75010, France
Centre Eugene Marquis
Rennes , 35042, France
Centre-Hospitalier Universitaire de Saint-Etienne
Saint-Etienne , 42055, France
Centre Alexis Vautrin
Vandoeuvre les Nancy , 54511, France
Institut Gustave Roussy (IGR)
Villejuif , 94805, France
Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
Hufelandstr. 55 Essen, 45122, Germany
Klinikum Augsburg
Augsburg , 86156, Germany
Charite Universitaets medizin Berlin
Berlin , 10117, Germany
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin , 12200, Germany
Universitaetsklinikum Dusseldorf
Duesseldorf , 40225, Germany
Universitaetsklinikum Erlangen
Erlangen , 91052, Germany
Universitaetsklinikum Essen
Essen , 45122, Germany
Universitaetsklinikum Heidelberg
Heidelburg , 69115, Germany
Klinikum der Friedrich-Schiller-Universitaet Jena
Jena , 07740, Germany
Klinikum Mannheim gGmbH
Mannheim , 68167, Germany
University of Mannheim
Mannheim , , Germany
Klinikum Rechts der Isar / TU Muenchen
Muenchen , 81675, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , 97080, Germany
National Institute of Oncology
Budapest , H-112, Hungary
University of Debrecen, Medical and Health Sciences Center
Debrecen , H-401, Hungary
Semmelweis Hospital
Miskolc , H-352, Hungary
University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
Szeged , H-672, Hungary
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam , 1081 , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht , 6229 , Netherlands
Mary Potter Oncology Centre
Groenkloof , 0181, South Africa
GVI Oncology
Panorama , 7500, South Africa
Mary Potter Oncology Centre
Pretoria , 0181, South Africa
Sandton Onocology Medical Research
Sandton , 2199, South Africa
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne Rue du Bugnon 46, CH-10, Switzerland
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne , CH-10, Switzerland
Dermatologische Klinik Universitatsspital Zurich
Zurich , 8091, Switzerland
St. Luke's Cancer Center, The Royal Surrey County Hospital
Guildford Surry, GU2 7, United Kingdom
Velindre Hospital
Cardiff , CF14 , United Kingdom
Ninewells Hospital
Dundee , DD1 9, United Kingdom
Christie Hospital
Manchester , M20 4, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Churchill Hospital
Oxford , OX3 7, United Kingdom
Poole Hospital
Poole , BH15 , United Kingdom
Weston Park Hospital
Sheffield , S10 2, United Kingdom
Southampton General
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1783

Study ID:

NCT00094653

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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