|Inclusion Criteria:||1) Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.|
2) Histologically confirmed Stage III (unresectable) or Stage IV melanoma.
3) Must have failed at least one systemic therapy for malignant melanoma or be intolerant to at least one prior systemic treatment. Note: Enrollees must not be eligible for a clinical study with ipilimumab.
4) Subjects with brain metastases are allowed. (Systemic steroids should be avoided if possible as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose.)
5) Primary ocular and mucosal melanomas are allowed.
6) Must be at least 28 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment. Prior treatment must be completed by the time of study drug administration.
7) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
8) Required values for initial laboratory tests: WBC: >/= 2000/uL ANC: >/= 1000/uL Platelets: >/=75 x 10^3/uL Hemoglobin: >/= 9 g/dL (may be transfused); Creatinine: </= 2 x ULN AST/ALT: </= 2.5 x ULN for subjects without liver metastasis </= 5 times for liver metastases Bilirubin: </= 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL).
9) No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
10) Prior treatment with an anti-CTLA-4 drug is allowed.
11) Men and women, at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >/= 12 consecutive months;
12) (cont'd from # 11) or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
13) (cont'd from # 11) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of investigational product.