Status:
COMPLETED
MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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,...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
1783 Patients enrolled
Trial Details
Trial ID
NCT00094653
Start Date
September 1 2004
End Date
October 1 2009
Last Update
July 11 2011
Active Locations (209)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
University Medical Center
Tucson, Arizona, United States, 85724
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
San Diego Cancer Center
Encinitas, California, United States, 92024