Trial Information

Summary: A Randomized, Multi-Dose, Open-Label Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects with Previously Treated Unresectable Stage III or IV Melanom

The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free (that is, the cancer has not gotten substantially worse), when treated with Anti-CD 137 (4-1BB) (BMS-663513 at 0.1 mg/kg. 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks.

Inclusion Criteria

• Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
• Men and women, who are at least 18 years of age.

Exclusion Criteria

• Required the use corticosteroid therapy or DCVax®-Brain for this indication.
• Discontinue treatment for < 4 weeks before randomization in this study.

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Trial listings updated: June 1, 2008 at 6:44:24 AM