Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

Conditions

• Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — DRUG
  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
• Placebo — DRUG
  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
• Dacarbazine — DRUG
  Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Study Details

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

Key Dates

Start date

Aug 31, 2006

Status verified

Oct 2014

Primary completion

Jan 31, 2011

Completion

Oct 31, 2013

Study Design

Enrollment

681 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Ipilimumab and Dacarbazine
  In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase
• Active Comparator: Arm B: Placebo and Dacarbazine

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months ]

Locations (32)

Find similar trials in Anaheim, CA

Related Studies

• Evaluation for NCI Surgery Branch Clinical Research Protocols
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Harvesting Cells for Experimental Cancer Treatments
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
• Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland