Conditions: Melanoma
Keywords: Stage IIIc N3 (unresectable) Stage IV melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 681
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

Detailed description:
For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

Arms:
arm 1: In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase arm 2: None

Interventions: intervention 1: Ipilimumab intervention 2: Placebo intervention 3: Dacarbazine
Intervention descriptions: intervention 1: Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent

In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression intervention 2: Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent intervention 3: Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Protocol document: