Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With 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