Objectives: Ipilimumab (Yervoy), an FDA-approved monoclonal antibody against CTLA-4, is the first treatment proven to improve melanoma survival. This randomized, phase III trial asks whether it can improve recurrence-free and/or overall survival if used in the adjuvant setting.
Key entry or exclusion criteria: Patients must have stage IIIB, IIIC, or IV (M1a or M1b) disease (including recurrent disease) that has been completely resected within the previous 12 weeks.
Locations: 67 sites.
Goal: 1,500 patients.
Study sponsor: Eastern Cooperative Oncology Group in collaboration with the National Cancer Institute.
Links for more information: clinicaltrials.gov/ct2/show/NCT01274338
NIH clinical trials identifier: NCT01274338