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.
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.
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
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There are 166 Locations for this study
Tucson Arizona, 85724, United States
Tucson Arizona, 85724, United States
Duarte California, 91010, United States
Encinitas California, 92024, United States
La Jolla California, 92037, United States
La Jolla California, 92037, United States
La Jolla California, 92093, United States
Long Beach California, 90813, United States
Los Angeles California, 90025, United States
Los Angeles California, 90025, United States
Los Angeles California, 90033, United States
Oceanside California, 92056, United States
Pasadena California, 91105, United States
San Diego California, 92103, United States
San Francisco California, 94109, United States
Santa Monica California, 90404, United States
Vista California, 92081, United States
Aurora Colorado, 80010, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
Boulder Colorado, 80304, United States
Colorado Springs Colorado, 80909, United States
Denver Colorado, 80218, United States
Denver Colorado, 80262, United States
Lakewood Colorado, 80228, United States
Littleton Colorado, 80120, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
New Haven Connecticut, 06520, United States
Aventura Florida, 33180, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32209, United States
Jacksonville Florida, 32209, United States
Miami Beach Florida, 33140, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Palm Beach Gardens Florida, 33410, United States
Tampa Florida, 33612, United States
Wellington Florida, 33414, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30322, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Maywood Illinois, 60153, United States
Goshen Indiana, 46526, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46237, United States
Indianapolis Indiana, 46237, United States
Noblesville Indiana, 46060, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21231, United States
Baltimore Maryland, 21237, United States
Lutherville Maryland, 21093, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Dearborn Michigan, 48126, United States
Detroit Michigan, 48202, United States
West Bloomfield Michigan, 48322, United States
Coon Rapids Minnesota, 55433, United States
Fridley Minnesota, 55432, United States
Robbinsdale Minnesota, 55422, United States
Olive Branch Mississippi, 38654, United States
Columbia Missouri, 65203, United States
St. Joseph Missouri, 64507, United States
St. Louis Missouri, 63110, United States
St. Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07962, United States
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08901, United States
Summit New Jersey, 07901, United States
Albuquerque New Mexico, 87109, United States
East Syracuse New York, 13057, United States
New York New York, 10021, United States
New York New York, 10032, United States
Chapel Hill North Carolina, 27599, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97213, United States
Portland Oregon, 97213, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15232, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29615, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29307, United States
Bartlett Tennessee, 38133, United States
Collierville Tennessee, 38017, United States
Memphis Tennessee, 38119, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37232, United States
Arlington Texas, 76012, United States
Dallas Texas, 75230, United States
Lubbock Texas, 79410, United States
Richardson Texas, 75080, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05405, United States
Ciudad de Buenos Aires Buenos Aires, , Argentina
La Plata Provincia de Buenos Aires, 1900, Argentina
Buenos Aires , , Argentina
Buenos Aires , , Argentina
Ciudad de Buenos Aires , C1280, Argentina
Ciudad de Buenos Aires , C1405, Argentina
Ciudad de Buenos Aires , C1405, Argentina
Ciudad de Buenos Aires , C1417, Argentina
Ciudad de Buenos Aires , C1426, Argentina
Ciudad de Buenos Aires , C1426, Argentina
Cordoba , X5016, Argentina
Cordoba , , Argentina
Santa Fe , S3000, Argentina
Santa Fe , , Argentina
Brussels , 1000, Belgium
Brussels , 1070, Belgium
Brussels , 1070, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Yvoir , 5530, Belgium
Goiania GO, , Brazil
Londrina PR, , Brazil
Porto Alegre RS, , Brazil
Barretos SP, , Brazil
Jau SP, , Brazil
Santo Andre SP, , Brazil
Sao Paulo SP, , Brazil
Barretos - SP , 14784, Brazil
Belo Horizonte - MG , 34000, Brazil
Goiania - GO , 74605, Brazil
Londrina - PR , 86050, Brazil
Porto Alegre - RS , 90035, Brazil
Porto Alegre - RS , 90610, Brazil
Porto Alegre , 90035, Brazil
Santo Andre-SP , 09090, Brazil
Sao Paulo - SP , 05403, Brazil
Sao Paulo-SP , 01308, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
St. John's Newfoundland and Labrador, A1B 3, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Independencia Santiago, , Chile
Recoleta Santiago, , Chile
Renaca Vina Del Mar, , Chile
Santiago , , Chile
Santiago , , Chile
Lille , 59020, France
Lyon , 69373, France
Marseille , 13009, France
Montpellier , 34295, France
Nantes , 44093, France
Nice cedex 2 , 06189, France
Paris , 75010, France
Rennes , 35042, France
Saint-Etienne , 42055, France
Vandoeuvre les Nancy , 54511, France
Villejuif , 94805, France
Hufelandstr. 55 Essen, 45122, Germany
Augsburg , 86156, Germany
Berlin , 10117, Germany
Berlin , 12200, Germany
Duesseldorf , 40225, Germany
Erlangen , 91052, Germany
Essen , 45122, Germany
Heidelburg , 69115, Germany
Jena , 07740, Germany
Mannheim , 68167, Germany
Mannheim , , Germany
Muenchen , 81675, Germany
Tuebingen , 72076, Germany
Wuerzburg , 97080, Germany
Budapest , H-112, Hungary
Debrecen , H-401, Hungary
Miskolc , H-352, Hungary
Szeged , H-672, Hungary
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Maastricht , 6229 , Netherlands
Groenkloof , 0181, South Africa
Panorama , 7500, South Africa
Pretoria , 0181, South Africa
Sandton , 2199, South Africa
Lausanne Rue du Bugnon 46, CH-10, Switzerland
Lausanne , CH-10, Switzerland
Zurich , 8091, Switzerland
Guildford Surry, GU2 7, United Kingdom
Cardiff , CF14 , United Kingdom
Dundee , DD1 9, United Kingdom
Manchester , M20 4, United Kingdom
Nottingham , NG5 1, United Kingdom
Oxford , OX3 7, United Kingdom
Poole , BH15 , United Kingdom
Sheffield , S10 2, United Kingdom
Southampton , SO16 , United Kingdom
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