A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
The primary objective of this study is to determine the progression-free survival (PFS) of
 participants with previously untreated metastatic malignant melanoma when treated with
 IMC-1121B (ramucirumab) alone or in combination with dacarbazine.
The purpose of this study is to determine the antitumor activity and safety profile of
 IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants
 with metastatic melanoma who have not received prior chemotherapy for this disease.
Inclusion Criteria:

 -  The participant has histologically or cytologically confirmed melanoma that is stage
 IV (metastatic)

 -  The participant has an Eastern Cooperative Oncology Performance Status (ECOG PS) of
 0-1

 -  The participant 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 participant has adequate hematological functions [absolute neutrophil count (ANC)
 ≥ 1500 cells/microliter (μL), hemoglobin ≥ 9 grams/deciliter (g/dL) and platelets ≥
 100,000 cells/μL].

 -  The participant 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 participant has serum creatinine ≤ 1.5 x ULN [or a calculated creatinine clearance
 > 60 milliliters/minute (mL/min)]

 -  The participant'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 milligrams (mg) of protein in 24 hours to allow participation in
 the study]

 -  The participant 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 participant has mucosal or intra-ocular melanoma

 -  The participant has known or suspected brain or leptomeningeal metastases

 -  The participant has had prior cytotoxic chemotherapy for metastatic malignant melanoma

 -  The participant 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 participant has a nonhealing wound or ulcer

 -  The participant has a known alcohol or drug dependency

 -  The participant is pregnant or breastfeeding

 -  The participant 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 participant 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