Conditions: Metastatic Malignant Melanoma
Keywords: Phase II Melanoma IMC-1121B ImClone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: IMC-1121B (ramucirumab) arm 2: IMC-1121B (ramucirumab) + dacarbazine

Interventions: intervention 1: IMC-1121B (ramucirumab) intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. intervention 2: 1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.

Protocol document: