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Therapeutic Areas: Dermatology/Plastic Surgery | Oncology
Disease Category: Melanoma

Trial Information

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

Ocular or mucosal melanoma.

Complete surgical resection of all identifiable sites of disease.

Clinical and/or radiographic evidence of cerebral or subdural metastases and/or progression of central nervous system (CNS) metastases within the past 4 weeks. Subjects who have a history of CNS metastasis but have no radiographic (eg, brain, MRI or contrast CT) or clinical evidence of residual tumor (eg, following complete surgical resection) are excluded from participation in this study based on the following:

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

Indiana University Cancer Center
535 Barnhill Dr. Rm 441, Rm 441
Indianapolis, IN 46202

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