Phase II Study to Determine Predictive Markers of Response to MDX-010 (BMS-734016)

During the Induction Phase, each patient will receive MDX-010 (BMS-734016) at either a dose of 3 or 10 mg/kg intravenous (IV) administered as 4 single doses every three weeks (Weeks 1, 4, 7 and 10). During the Maintenance Phase, non-progressing patients who have not experienced toxicities requiring discontinuation in the Induction Phase are eligible to receive additional single doses of MDX-010 (BMS-734016) every 12 Weeks (i.e. Week 24, 36, 48 in the first year) until progression, toxicities requiring discontinuation or withdrawal of consent. At the time of progression, patients who continue to have performance status ECOG 0-1, no history of prohibitive toxicity, and a best objective response of stable disease or better at Week 12 will be offered, at Investigator’s discretion, entry onto a separate companion study which examines the safety and efficacy of re-induction and maintenance at the time of progression. Progressing patients who are not eligible or choose not to enroll onto the companion study will enter the Follow-Up Phase with no further dosing