drugset / Trial / NCT00357461

Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma

NCT00357461

RandomizedOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma. PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.

Timeline

Start
2006-05
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous
Subject gp100:209-217(210M) Peptide Subcutaneous
Subject gp100:280-288(288V) Vaccine Subcutaneous
Background incomplete Freund's adjuvant Other / unclassified Subcutaneous

Indications