A Study of Ramucirumab With or Without Dacarbazine in Metastatic Malignant Melanoma

Inclusion Criteria:

• The patient has histologically or cytologically confirmed melanoma that is stage IV (metastatic)
• The patient has an ECOG PS of 0-1
• The patient has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the first dose of study therapy
• The patient has adequate hematological functions (absolute neutrophil count [ANC]≥ 1500 cells/μL, hemoglobin ≥ 9 g/dL and platelets ≥ 100,000 cells/μL).
• The patient has adequate hepatic function (bilirubin within normal limits [WNL],aspartate transaminase [AST] and/or alanine transaminase [ALT] ≤ 2.5 times the upper limit of normal [ULN], or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases)
• The patient has serum creatinine ≤ 1.5 x ULN (or a calculated creatinine clearance > 60 mL/min)
• The patient's urinary protein ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study)
• The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN

Exclusion Criteria

• The patient has mucosal or intra-ocular melanoma
• The patient has known or suspected brain or leptomeningeal metastases
• The patient has had prior cytotoxic chemotherapy for metastatic malignant melanoma
• The patient has had more than one line of biologic, immunologic or vaccine-based therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced disease)
• The patient has a nonhealing wound or ulcer
• The patient has a known alcohol or drug dependency
• The patient is pregnant or breastfeeding
• The patient has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results
• The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator