a study of imc-1121b (ramucirumab) with or without dacarbazine in metastatic malignant melanoma

Conditions: Metastatic Malignant Melanoma

Summary: 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.

Eligibility criteria:
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

Keywords: phase ii melanoma imc-1121b imclone