Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma

Inclusion Criteria:Pre-surgery Inclusion criteria:

* Signed informed consent
* ≥ 18 years of age
* Stage III or Stage IV melanoma according to TNM staging criteria/AJCC version 7 determined by PET/MRI/CT scan
* ECOG score 0 or 1
* Life expectancy ≥6 months
* Candidate for surgical resection with viable melanoma tissue to ascertain ≥ 7 grams of viable cancer tissue (in aggregate), which is equivalent to a ≥ 2 cm lesion on CT/MRI or clinical examination
* Adequate cardiac function (≤ NYHA class II)
* Adequate bone marrow function, including: absolute granulocyte count (ANC) ≥ 1,500x106/L, absolute lymphocyte count (ALC) ≥ 500/mm3, platelets count ≥100,000 x 106/mm3. Adequate liver function including: serum glutamic oxaloacetic transaminases/aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the upper limit of institutional normal (IULNs), bilirubin ≤ 1.5 mg/dL or 25 µmol/L (SI units). Adequate renal function: BUN and Serum creatinine of ≤ 1.5 mg/dL or 130 µmol/L (SI units)
* Female subjects of childbearing potential and fertile males must agree to use adequate contraception during the course of the study. Adequate contraception includes condoms with contraceptive foam; oral, implantable or injectable contraceptives; contraceptive patch; intrauterine device; diaphragm with spermicidal gel; or a sexual partner who is surgically sterilized or postmenopausal.

  * Post-surgery Inclusion Criteria (must be completed within 4 weeks of surgery)
* Histologically and clinically confirmed Stage III and/or Stage IV malignant melanoma according to TNM Staging Criteria/AJCC version 7 confirmed by PET/CT scan
* Measurable disease for target lesion clinical and radiological monitoring
* ECOG score 0 or 1
* Adequate cardiac function (≤ NYHA class II)
* Adequate bone marrow function, liver, and renal function
* ≥ 6 doses of vaccine for clinical use

Exclusion Criteria: Pre-Surgery Exclusion Criteria:

* Primary mucosal or primary ocular melanomas
* Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer
* Primary or secondary immunodeficiency (including immunosuppressive disease, or systemic use of corticosteroids or other immunosuppressive medications)
* Patients with history of HIV1 and 2, HTLV-1, HBV or active HCV.
* Patients with history of connective tissue disorders
* Prior ipilimumab or melanoma vaccine therapy
* Prior therapy with IL-2
* Prior chemotherapy, small molecule targeted therapy, interferon within 3 months prior to enrollment
* Prior investigational products administration within 4 weeks prior to enrollment
* Prior splenectomy
* Symptomatic CNS metastases or spinal cord compression
* Uncontrolled infection or other serious medical illnesses
* Any medical conditions that, in the opinion of the investigator, would preclude use of ipilimumab, including ipilimumab hypersensitivity
* Women who are pregnant or breast-feeding
* Concurrent participation in investigational trials

  * Post-surgery Exclusion Criteria (must be completed within 4 weeks of surgery):
* Emergence of contraindicated clinical condition