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| Sponsor: | Medarex |
|---|---|
| Information provided by: | Medarex |
| ClinicalTrials.gov Identifier: | NCT00094653 |
Purpose
The purpose of this study is to determine the safety and efficacy of MDX-010 (anti-CTLA4) in combination with MDX-1379 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 IL-2, dacarbazine, and/or temozolomide, have 1) relapsed following an objective 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Metastases |
Drug: MDX-010 (anti-CTLA4) monoclonal antibody Biological: MDX-1379 Melanoma Peptide Vaccine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma |
| Enrollment: | 676 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Melanoma Peptide Vaccine (MDX-1379) + Placebo
|
Biological: MDX-1379 Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 1mL each, to each thigh), every 3 weeks for 4 doses.
|
|
2: Experimental
MDX-010 + MDX-1379 (Melanoma Peptide Vaccine)
|
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (iv infusion over 90 minutes), every 3 weeks for 4 doses
Biological: MDX-1379 Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 1mL each, to each thigh), every 3 weeks for 4 doses.
|
|
3: Active Comparator
MDX-010 + Placebo
|
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (iv infusion over 90 minutes), every 3 weeks for 4 doses
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| University Medical Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Cancer Institute Medical Group, Inc | |
| Santa Monica, California, United States, 90404 | |
| Cancer Institute Medical Group, Inc | |
| Los Angeles, California, United States, 90025 | |
| San Diego Cancer Center | |
| Vista, California, United States, 92081 | |
| San Diego Cancer Center | |
| Encinitas, California, United States, 92024 | |
| North County Oncology Medical Clinical, Inc. | |
| Oceanside, California, United States, 92056 | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| Scripps Cancer Center | |
| La Jolla, California, United States, 92037 | |
| La Jolla Hematology and Oncology Medical Group | |
| La Jolla, California, United States, 92037 | |
| St. Mary's Medical Center - Northern California Melanoma Center | |
| San Francisco, California, United States, 94109 | |
| University of California, San Diego | |
| San Diego, California, United States, 92103 | |
| Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| The Angeles Clinic and Research Institute | |
| Los Angeles, California, United States, 90025 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers | |
| Boulder, Colorado, United States, 80304 | |
| Rocky Mountain Cancer Centers | |
| Lakewood, Colorado, United States, 80228 | |
| Rocky Mountain Cancer Centers | |
| Longmont, Colorado, United States, 80501 | |
| Rocky Mountain Cancer Centers | |
| Lone Tree, Colorado, United States, 80124 | |
| University of Colorado Hospital | |
| Denver, Colorado, United States, 80262 | |
| Rocky Mountain Cancer Centers | |
| Denver, Colorado, United States, 80218 | |
| Rocky Mountain Cancer Centers | |
| Aurora, Colorado, United States, 80012 | |
| Rocky Mountain Cancer Centers | |
| Littleton, Colorado, United States, 80120 | |
| Anschutz Cancer Pavilion | |
| Aurora, Colorado, United States, 80010 | |
| Rocky Mountain Cancer Centers | |
| Colorado Springs, Colorado, United States, 80909 | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Yale University School of Medicine - Oncology Outpatient Clinic | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Mount Sinai Comprehensive Cancer Center | |
| Miami Beach, Florida, United States, 33140 | |
| Mount Sinai Comprehensive Cancer Center at Aventura | |
| Aventura, Florida, United States, 33180 | |
| Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Palm Beach Cancer Institute | |
| West Palm Beach, Florida, United States, 33401 | |
| Shands Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| Palm Beach Cancer Institute | |
| Wellington, Florida, United States, 33414 | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Memorial Regional Cancer Center | |
| Hollywood, Florida, United States, 33021 | |
| University of Florida/Jacksonville Faculty Clinic | |
| Jacksonville, Florida, United States, 32209 | |
| Palm Beach Cancer Institute | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| University of Miami Hospital & Clinics | |
| Miami, Florida, United States, 33136 | |
| Jackson Memorial Hospital & Clinics | |
| Miami, Florida, United States, 33136 | |
| M.D. Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Emory University Hospital-Winship Cancer Institute | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Decatur Memorial Hospital | |
| Decatur, Illinois, United States, 62526 | |
| Cancer Care Specialists of Central IL | |
| Effingham, Illinois, United States, 62401 | |
| Cancer Care Specialists of Central IL | |
| Decatur, Illinois, United States, 62526 | |
| Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr. | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Indiana Oncology Hematology Consultants North | |
| Indianapolis, Indiana, United States, 46202 | |
| Indiana Oncology Hematology South | |
| Indianapolis, Indiana, United States, 46237 | |
| Indiana Oncology Hematology Consutants of Noblesville | |
| Noblesville, Indiana, United States, 46060 | |
| Center for Cancer Care at Goshen Health System | |
| Goshen, Indiana, United States, 46526 | |
| American Health Network of IN, LLC | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Kentucky | |
| Norton Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| University of Louisville Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Lutherville, Maryland, United States, 21093 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Brigham and Womens Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Isreal Dec Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Henry Ford Medical Center- West Bloomfield | |
| West Bloomfield, Michigan, United States, 48322 | |
| Henry Ford Medical Center | |
| Dearborn, Michigan, United States, 48126 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Hubert H Humphrey Cancer Center | |
| Robbinsdale, Minnesota, United States, 55422 | |
| Humphrey Cancer Center | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Humphrey Cancer Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, Mississippi | |
| Family Cancer Center | |
| Olive Branch, Mississippi, United States, 38654 | |
| United States, Missouri | |
| Washington Unv. School of Med./ Siteman Cancer Center | |
| St. Louis, Missouri, United States, 63110 | |
| St. Joseph Oncology, Inc | |
| St. Joseph, Missouri, United States, 64507 | |
| Ellis Fischel Cancer Center | |
| Columbia, Missouri, United States, 65203 | |
| Barnes Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Overlook Oncology Center | |
| Summit, New Jersey, United States, 07901 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| The Cancer Center at Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Hematology-Oncology Associates of Northern NJ, PA | |
| Morristown, New Jersey, United States, 07962 | |
| The Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New Mexico | |
| New Mexico Oncology Hematology Consultants, Ltd. | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Hematology-Oncology Associates of CNY | |
| East Syracuse, New York, United States, 13057 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Columbia University Medical Center, Irving Center for Clinical Research | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7050 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| The Christ Hospital Cancer Center | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| The Oregon Clinical | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Thomas Jefferson University Hosptital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Hillman Cancer Research Pavilion | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| Cancer Centers of the Carolinas | |
| Spartanburg, South Carolina, United States, 29307 | |
| Cancer Centers of the Carolinas | |
| Easley, South Carolina, United States, 29640 | |
| Cancer Centers of the Carolinas | |
| Seneca, South Carolina, United States, 29672 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| Family Cancer Center | |
| Collierville, Tennessee, United States, 38017 | |
| Family Cancer Center | |
| Memphis, Tennessee, United States, 38119 | |
| Family Cancer Center | |
| Bartlett, Tennessee, United States, 38133 | |
| United States, Texas | |
| Arlington Cancer Center | |
| Arlington, Texas, United States, 76012 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410 | |
| Center for Oncology Research and Treatment | |
| Dallas, Texas, United States, 75230 | |
| Center for Oncology Research and Treatment | |
| Richardson, Texas, United States, 75080 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05405 | |
| Argentina | |
| ISIS Clinica Especializada | |
| Santa Fe, Argentina, S3000FFU | |
| Hospital General de Agudos Carlos G. Durand | |
| Ciudad de Buenos Aires, Argentina, C1405DCS | |
| Hospital Privado de Cordoba S.A. | |
| Cordoba, Argentina, X5016KEH | |
| Instituto Alexander Fleming | |
| Ciudad de Buenos Aires, Argentina, C1426DRB | |
| Hospital Militar Central | |
| Ciudad de Buenos Aires, Argentina, C1426BOS | |
| Instituto de Oncologia Angel H. Roffo | |
| Ciudad de Buenos Aires, Argentina, C1417DTB | |
| Hospital Britanico de Buenos Aires | |
| Ciudad de Buenos Aires, Argentina, C1280AEB | |
| Hospital Municipal de Oncologia Maria Curie | |
| Ciudad de Buenos Aires, Argentina, C1405BWU | |
| Hospital Militar Central | |
| Buenos Aires, Argentina | |
| Instituto Medico Especializado Alexander Fleming | |
| Buenos Aires, Argentina | |
| Hospital Privado Centro Medico de Cordoba S.A. | |
| Cordoba, Argentina | |
| ISIS Clinica Especializada | |
| Santa Fe, Argentina | |
| Argentina, Buenos Aires | |
| Hospital Municipal de Oncoligia Maria Curie | |
| Ciudad de Buenos Aires, Buenos Aires, Argentina | |
| Argentina, Provincia de Buenos Aires | |
| Instituto Medico Platense | |
| La Plata, Provincia de Buenos Aires, Argentina, 1900 | |
| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| U.Z. Gent | |
| Gent, Belgium, 9000 | |
| Universitair Ziekenhuis Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Erasme Hospital | |
| Brussels, Belgium, 1070 | |
| Cliniques Universitaires UCL de Mont-Godinne | |
| Yvoir, Belgium, 5530 | |
| Erasme Hospital, Free Universtiy of Brussels | |
| Brussels, Belgium, 1070 | |
| Brazil | |
| Santo Andre Diagnosticos e Tratamentos Ltda. | |
| Santo Andre-SP, Brazil, 09090-780 | |
| Hospital Sirio Labanes | |
| Sao Paulo-SP, Brazil, 01308-050 | |
| Hospital Sao Lucas - PUCRS | |
| Porto Alegre - Rs, Brazil, 90610-000 | |
| Hospital Araujo Jorge | |
| Goiania - Go, Brazil, 74605-070 | |
| Fund. SOAD / HC de Porto Alegre | |
| Porto Alegre - Rs, Brazil, 90035-003 | |
| HC-FMUSP | |
| Sao Paulo - Sp, Brazil, 05403-000 | |
| Pro Onco Centro Tratemento Oncologico | |
| Londrina - Pr, Brazil, 86050-190 | |
| Hospital de Cancer de Barretos - Fundacao Pio XII | |
| Barretos - Sp, Brazil, 14784-400 | |
| Biocor - Hosp. de Doencas Cardiovasculares Ltda. | |
| Belo Horizonte - Mg, Brazil, 34000-000 | |
| Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD | |
| Porto Alegre, Brazil, 90035-003 | |
| Brazil, GO | |
| Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias | |
| Goiania, GO, Brazil | |
| Brazil, PR | |
| Pro Onco Centro Tratamento Oncologico | |
| Londrina, PR, Brazil | |
| Brazil, RS | |
| Hospital Sao Lucas da PUCRS | |
| Porto Alegre, RS, Brazil | |
| Brazil, SP | |
| 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 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Dr. H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Cancer Centre of Southeastern Ontario at KGH | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| The Ottawa Hospital Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Sir Mortimer B. Davis - Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Chile | |
| Fundacion Arturo Lopez Perez | |
| Santiago, Chile | |
| Hospital Barros Luco | |
| Santiago, Chile | |
| Chile, Santiago | |
| Clinica Davila | |
| Recoleta, Santiago, Chile | |
| Instituto Nacional del Cancer | |
| Independencia, Santiago, Chile | |
| Chile, Vina Del Mar | |
| Clinica Renaca | |
| Renaca, Vina Del Mar, Chile | |
| France | |
| Centre Leon Berard | |
| Lyon, France, 69373 Cedex 08 | |
| Hopital Saint-Eloi | |
| Montpellier, France, 34295 Cedex 5 | |
| Hotel Dieu | |
| Nantes, France, 44093 Cedex 1 | |
| Centre-Hospitalier Universitaire de Saint-Etienne | |
| Saint-Etienne, France, 42055 Cedex 2 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 Cedex | |
| Institut Gustave Roussy (IGR) | |
| Villejuif, France, 94805 Cedex | |
| Centre Oscar Lambret | |
| Lille, France, 59020 Cedex | |
| Hopital Sainte-Marguerite | |
| Marseille, France, 13009 | |
| Hopital Saint-Louis | |
| Paris, France, 75010 10 | |
| Centre Alexis Vautrin | |
| Vandoeuvre Les Nancy, France, 54511 Cedex | |
| Centre Antoine Lacassagne | |
| Nice Cedex 2, France, 06189 | |
| Germany | |
| Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin | |
| Berlin, Germany, 12200 | |
| Universitaetsklinikum Wuerzburg | |
| Wuerzburg, Germany, 97080 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, 72076 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, 45122 | |
| Universitaetsklinikum Heidelberg | |
| Heidelburg, Germany, 69115 | |
| Klinikum Rechts der Isar / TU Muenchen | |
| Muenchen, Germany, 81675 | |
| Charite Universitaets medizin Berlin | |
| Berlin, Germany, 10117 | |
| Klinikum der Friedrich-Schiller-Universitaet Jena | |
| Jena, Germany, 07740 | |
| Universitaetsklinikum Erlangen | |
| Erlangen, Germany, 91052 | |
| Universitaetsklinikum Dusseldorf | |
| Duesseldorf, Germany, 40225 | |
| Klinikum Augsburg | |
| Augsburg, Germany, 86156 | |
| Klinikum Mannheim gGmbH | |
| Mannheim, Germany, 68167 | |
| University of Mannheim | |
| Mannheim, Germany | |
| Germany, Essen | |
| Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie | |
| Hufelandstr. 55, Essen, Germany, 45122 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, H-1122 | |
| Semmelweis Hospital | |
| Miskolc, Hungary, H-3529 | |
| University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center | |
| Szeged, Hungary, H-6720 | |
| University of Debrecen, Medical and Health Sciences Center | |
| Debrecen, Hungary, H-4012 | |
| Netherlands | |
| Antoni Van Leeuwenhoek Ziekenhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6229 HX | |
| Vrije Universiteit Medisch Centrum (VUMC) | |
| Amsterdam, Netherlands, 1081 HV | |
| South Africa | |
| Mary Potter Oncology Centre | |
| Pretoria, South Africa, 0181 | |
| GVI Oncology | |
| Panorama, South Africa, 7500 | |
| Sandton Onocology Medical Research | |
| Sandton, South Africa, 2199 | |
| Mary Potter Oncology Centre | |
| Groenkloof, South Africa, 0181 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois - CHUV | |
| Lausanne, Switzerland, CH-1011 | |
| Dermatologische Klinik Universitatsspital Zurich | |
| Zurich, Switzerland, 8091 | |
| Switzerland, Rue du Bugnon 46 | |
| Centre Hospitalier Universitaire Vaudois - CHUV | |
| Lausanne, Rue du Bugnon 46, Switzerland, CH-1011 | |
| United Kingdom | |
| Velindre Hospital | |
| Cardiff, United Kingdom, CF14 2TL | |
| Churchill Hospital | |
| Oxford, United Kingdom, OX3 7LJ | |
| Christie Hospital | |
| Manchester, United Kingdom, M20 4BX | |
| Weston Park Hospital | |
| Sheffield, United Kingdom, S10 2SJ | |
| Poole Hospital | |
| Poole, United Kingdom, BH15 2JB | |
| Southampton General | |
| Southampton, United Kingdom, SO16 6YD | |
| Nottingham City Hospital | |
| Nottingham, United Kingdom, NG5 1PB | |
| Ninewells Hospital | |
| Dundee, United Kingdom, DD1 9SY | |
| Weston Park Hospital | |
| Sheffield, United Kingdom, S10 2SJ | |
| United Kingdom, Surry | |
| St. Luke's Cancer Center, The Royal Surrey County Hospital | |
| Guildford, Surry, United Kingdom, GU2 7XX | |
| Study Director: | Medarex Medical Monitor | Medarex |
More Information
| Responsible Party: | Medarex, Inc. ( Medarex Medical Monitor ) |
| Study ID Numbers: | MDX010-20 |
| Study First Received: | October 21, 2004 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00094653 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
melanoma metastatic melanoma skin cancer |
|
Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions Melanoma Neuroendocrine Tumors Antibodies, Monoclonal |
Neuroectodermal Tumors Neoplasms Neoplastic Processes Antibodies Pathologic Processes Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Nevi and Melanomas |
