Phase II, 2nd Line Melanoma - RAND Monotherapy

Status:	Completed
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	March 2008
End Date:	October 2009

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 Melanoma

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-CD137 (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

- Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain
metastasis are not eligible unless brain metastases are ruled out by computerized
axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable
brain metastasis and those who were previously treated with radiotherapy or surgery
must have no current evidence of symptomatic brain metastasis and are off steroid
therapy for at least 4 weeks prior to randomization

We found this trial at

sites

Indiana University Melvin and Bren Simon Cancer Center

535 Barnhill Dr
Indianapolis, Indiana 46202

(888) 600-4822