An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV melanoma

- Mucosal or ocular melanoma allowed

- Clinically evaluable disease

- HLA-A*0201 positive

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 6 months

Hematopoietic:

- WBC at least 2,500/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

- Hematocrit at least 30%

Hepatic:

- AST no greater than 3 times upper limit of normal (ULN)

- Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's
syndrome)

- Hepatitis B surface antigen negative

- Hepatitis C antibody nonreactive

Renal:

- Creatinine less than 2.0 mg/dL

Immunologic:

- Antinuclear antibody negative

- Thyroglobulin antibody normal

- Rheumatoid factor normal

- HIV negative

- No prior autoimmune disease (including uveitis and autoimmune inflammatory eye
disease)

- No active infection

- No hypersensitivity to Montanide ISA-51

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the
cervix

- No other underlying medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior immunotherapy for melanoma and recovered

- No prior gp100 peptides

- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Chemotherapy:

- At least 3 weeks since prior chemotherapy for melanoma and recovered

- No concurrent chemotherapy

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy for melanoma and recovered

- At least 4 weeks since prior systemic or topical corticosteroids

- No concurrent topical or systemic corticosteroids

Radiotherapy:

- At least 3 weeks since prior radiotherapy for melanoma and recovered

Surgery:

- Not specified

Other:

- No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)