Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

ABSTRACT:

Purpose

In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy.

Patients and methods

Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine).

Results

In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility bound

SUBMITTER: Ribas A 

PROVIDER: S-EPMC4878048 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature