A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.

Inclusion Criteria:

• Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
• Prior treatment must have been completed at least 4 weeks prior to enrollment
• No untreated primary or metastatic brain or meningeal tumors
• ECOG PS 0 or 1
• Meet all screening laboratory values

Exclusion Criteria:

• History of severe hypersensitivity reactions to other monoclonal antibodies
• Active autoimmune disease or a documented history of autoimmune disease
• Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
• Active infection
• Concurrent medical condition requiring the use of immunosuppressive medications