Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
Brief Summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases

  * T3 or T4, N0, M0
  * Must originate in the skin
* Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar

  * No more than 56 days since definitive surgical treatment (wide excision)
  * No more than 12 weeks since primary surgery
* No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease

PATIENT CHARACTERISTICS:

Age:

* 18 to 80

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.8 g/dL

Hepatic:

* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* LDH no greater than 2 times ULN
* Bilirubin no greater than 2 times ULN
* Hepatitis B and C negative

Renal:

* Creatinine normal

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer
* No autoimmune disorders
* No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids
* No history of CNS demyelinating or inflammatory disease
* No hereditary or acquired peripheral neuropathy
* No other significant medical or surgical condition or psychiatric disorders requiring medication that would preclude study
* No history of severe allergic reaction to shellfish
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy
* No other concurrent biologic therapy

Chemotherapy:

* No prior systemic chemotherapy
* No concurrent cytotoxic chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy except replacement therapy
* No concurrent corticosteroids
* No concurrent chronic systemic steroids

Radiotherapy:

* No prior adjuvant radiotherapy
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No prior preoperative infusion or perfusion therapy
* No concurrent immunosuppressive medications
* No other concurrent anticancer therapy
B: Inclusion Criteria:

* Informed Consent
* Measurable Disease
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Lab / imaging requirements
* Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
* Men and Women \> 18 years (16 were allowable)
* Prior therapy restriction (adjuvant only)

Exclusion:

* Pregnant / nursing
* Inadequate contraception
* Brain metastasis
* Primary ocular or mucosal melanoma
C: Inclusion Criteria:

* History of primary mucosal or acral/lentiginous melanoma
* Histologically documented stage III unresectable or IV metastatic melanoma
* ECOG Performance Status 0,1 or 2
* Estimated life expectancy of 6 months or greater
* 18 years of age or older
* Lab values as outlined in protocol
* Tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing
* Negative pregnancy test within 48 hours of starting treatment
* At least one measurable site of disease as defined by at least 1cm in greatest dimension

Exclusion Criteria:

* Severe and/or uncontrolled medical disease
* Pregnant or nursing mothers
* Known brain metastasis. History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
* Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in situ
* Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
* Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval \>450msec for males of \>470 msec for females
* Hypertension that cannot be controlled by medication
* Any of the following within 12 months prior to starting treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
* NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
* Concurrent treatment with warfarin
* Prior treatment with SU011248 or any other antiangiogenic agent
* No H2 blockers or proton pump inhibitors
* Known chronic liver disease
* Known HIV infection
* Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 4 weeks prior to study entry
* Major surgery within 4 weeks prior to study entry
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
D: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women ≥18 years of age
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
* Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
* Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Any active, known, or suspected autoimmune disease

Answer: B