MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
NCT ID: NCT00094653
Last Updated: 2011-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1783 participants
INTERVENTIONAL
2004-09-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo
MDX-1379 (gp100) Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
2
MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)
MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses
MDX-1379 (gp100) Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
3
MDX-010 (ipilimumab) + Placebo
MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses
Interventions
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MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses
MDX-1379 (gp100) Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
University Medical Center
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
San Diego Cancer Center
Encinitas, California, United States
La Jolla Hematology and Oncology Medical Group
La Jolla, California, United States
Scripps Cancer Center
La Jolla, California, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Cancer Institute Medical Group, Inc
Los Angeles, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
North County Oncology Medical Clinical, Inc.
Oceanside, California, United States
City of Hope Medical Group
Pasadena, California, United States
University of California, San Diego
San Diego, California, United States
St. Mary's Medical Center - Northern California Melanoma Center
San Francisco, California, United States
Cancer Institute Medical Group, Inc
Santa Monica, California, United States
San Diego Cancer Center
Vista, California, United States
Anschutz Cancer Pavilion
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
University of Colorado Hospital
Denver, Colorado, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, United States
Yale University School of Medicine - Oncology Outpatient Clinic
New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Memorial Regional Cancer Center
Hollywood, Florida, United States
Shands Jacksonville
Jacksonville, Florida, United States
University of Florida/Jacksonville Faculty Clinic
Jacksonville, Florida, United States
Jackson Memorial Hospital & Clinics
Miami, Florida, United States
University of Miami Hospital & Clinics
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Palm Beach Cancer Institute
Wellington, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Emory University Hospital-Winship Cancer Institute
Atlanta, Georgia, United States
Cancer Care Specialists of Central IL
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Cancer Care Specialists of Central IL
Effingham, Illinois, United States
Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
Maywood, Illinois, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States
Indiana Oncology Hematology Consultants North
Indianapolis, Indiana, United States
American Health Network of IN, LLC
Indianapolis, Indiana, United States
Indiana Oncology Hematology South
Indianapolis, Indiana, United States
Indiana Oncology Hematology Consutants of Noblesville
Noblesville, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lutherville, Maryland, United States
Beth Isreal Dec Medical Center
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Medical Center
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford Medical Center- West Bloomfield
West Bloomfield, Michigan, United States
Humphrey Cancer Center
Coon Rapids, Minnesota, United States
Humphrey Cancer Center
Fridley, Minnesota, United States
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, United States
Family Cancer Center
Olive Branch, Mississippi, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
St. Joseph Oncology, Inc
Saint Joseph, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Washington Unv. School of Med./ Siteman Cancer Center
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Overlook Oncology Center
Summit, New Jersey, United States
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Medical Center, Irving Center for Clinical Research
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
The Oregon Clinical
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hosptital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Hillman Cancer Research Pavilion
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Cancer Centers of the Carolinas
Easley, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, United States
Cancer Centers of the Carolinas
Spartanburg, South Carolina, United States
Family Cancer Center
Bartlett, Tennessee, United States
Family Cancer Center
Collierville, Tennessee, United States
Family Cancer Center
Memphis, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Center for Oncology Research and Treatment
Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Center for Oncology Research and Treatment
Richardson, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Hospital Municipal de Oncoligia Maria Curie
Ciudad de Buenos Aires, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Buenos Aires, Argentina
ISIS Clinica Especializada
Santa Fe, Santa Fe Province, Argentina
Hospital Militar Central
Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Ciudad de Buenos Aires, , Argentina
Hospital Municipal de Oncologia Maria Curie
Ciudad de Buenos Aires, , Argentina
Hospital General de Agudos Carlos G. Durand
Ciudad de Buenos Aires, , Argentina
Instituto de Oncologia Angel H. Roffo
Ciudad de Buenos Aires, , Argentina
Hospital Militar Central
Ciudad de Buenos Aires, , Argentina
Instituto Alexander Fleming
Ciudad de Buenos Aires, , Argentina
Hospital Privado de Cordoba S.A.
Córdoba, , Argentina
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba, , Argentina
ISIS Clinica Especializada
Santa Fe, , Argentina
Institut Jules Bordet
Brussels, , Belgium
Erasme Hospital, Free Universtiy of Brussels
Brussels, , Belgium
Erasme Hospital
Brussels, , Belgium
U.Z. Gent
Ghent, , Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, , Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, , Belgium
Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
Goiânia, Goiás, Brazil
Pro Onco Centro Tratamento Oncologico
Londrina, Paraná, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Fundacoa Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Santo Andre Diagnosticos aTratamentos
Santo André, São Paulo, Brazil
Sociedade Beneficante de Sennores - Hospital Sino Libante
São Paulo, São Paulo, Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos - SP, , Brazil
Biocor - Hosp. de Doencas Cardiovasculares Ltda.
Belo Horizonte - MG, , Brazil
Hospital Araujo Jorge
Goiania - GO, , Brazil
Pro Onco Centro Tratemento Oncologico
Londrina - PR, , Brazil
Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
Porto Alegre, , Brazil
Fund. SOAD / HC de Porto Alegre
Porto Alegre - RS, , Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre - RS, , Brazil
Santo Andre Diagnosticos e Tratamentos Ltda.
Santo Andre-SP, , Brazil
HC-FMUSP
Sao Paulo - SP, , Brazil
Hospital Sirio Labanes
Sao Paulo-SP, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Cancer Centre of Southeastern Ontario at KGH
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada
Instituto Nacional del Cancer
Independencia, Santiago Metropolitan, Chile
Clinica Davila
Recoleta, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile
Hospital Barros Luco
Santiago, Santiago Metropolitan, Chile
Clinica Renaca
Reñaca, Vina Del Mar, Chile
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital Sainte-Marguerite
Marseille, , France
Hopital Saint-Eloi
Montpellier, , France
Hotel Dieu
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Saint-Louis
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre-Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy (IGR)
Villejuif, , France
Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
Hufelandstr. 55, Hesse, Germany
Klinikum Augsburg
Augsburg, , Germany
Charite Universitaets medizin Berlin
Berlin, , Germany
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Dusseldorf
Düsseldorf, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Klinikum der Friedrich-Schiller-Universitaet Jena
Jena, , Germany
Klinikum Mannheim gGmbH
Mannheim, , Germany
University of Mannheim
Mannheim, , Germany
Klinikum Rechts der Isar / TU Muenchen
München, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
National Institute of Oncology
Budapest, , Hungary
University of Debrecen, Medical and Health Sciences Center
Debrecen, , Hungary
Semmelweis Hospital
Miskolc, , Hungary
University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
Szeged, , Hungary
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Mary Potter Oncology Centre
Groenkloof, , South Africa
GVI Oncology
Panorama, , South Africa
Mary Potter Oncology Centre
Pretoria, , South Africa
Sandton Onocology Medical Research
Sandton, , South Africa
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Rue Du Bugnon 46, Switzerland
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, , Switzerland
Dermatologische Klinik Universitatsspital Zurich
Zurich, , Switzerland
St. Luke's Cancer Center, The Royal Surrey County Hospital
Guildford, Surry, United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Poole Hospital
Poole, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Southampton General
Southampton, , United Kingdom
Countries
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References
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Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1.
Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015.
Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.
McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-2698. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13.
Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26.
Weber JS, Dummer R, de Pril V, Lebbe C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7.
Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.
Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5.
Other Identifiers
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CA184-002
Identifier Type: OTHER
Identifier Source: secondary_id
MDX010-20
Identifier Type: -
Identifier Source: org_study_id
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