• incidence and severity of treatment-emergent adverse events [ Time Frame: if they occur, they will be monitored through resolution of the event ] [ Designated as safety issue: Yes ]
  

• Clinical laboratory tests [ Time Frame: study duration ] [ Designated as safety issue: No ]
  
• physical examination [ Time Frame: screening ] [ Designated as safety issue: No ]
  
• electrocardiograms [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• vital sign measurements [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  

A total of 39 patients with recurrent or treatment refractory malignancies, including non-small cell lung cancer, colorectal cancer, malignant melanoma, renal clear cell cancer and hormone refractory prostate cancer, may be enrolled. Six patients each will be enrolled at dose levels 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. If the MTD is not reached, the additional patients will receive a dose determined by review of the available safety and efficacy data. Enrollment expansion cohort will be stopped if the incidence of dose-limiting toxicity at that dose level reaches 33%. the study will consist of 3 phases: the Single-dose Phase, the Re-treatment Phase, and the Follow-up Phase, which will include the tracking of patients for progression-free survival.

Single-dose Phase: Patients in the first cohort will be observed 24 hours post dose. Patients in subsequent cohorts will have an 8 hour post dose observation period. Patients who experience any adverse events during the 8 hours will continue to be monitored for an additional 16 hours. No two patients will be enrolled on the same day. Dosing of the next higher dose level will not be initiated until all 6 patients in the previous cohort have been dosed and 5 of the 6 patients have been followed for at least 4 weeks. Clinical laboratory test samples and pharmacokinetic samples will be collected. Immunogenicity testing will be performed, and immune function assays and tumor blood tests will be performed.

Re-treatment Phase: After participating in the Single-dose Phase, patients may be eligible for immediate retreatment with cycle(s) consisting of 2 additional doses of MDX-1106 (administered 4 weeks apart), provided they meet all criteria. Patients may be eligible to receive additional re-treatment cycles.

Long-term Follow-up Phase: Patients who respond to therapy with a complete response or partial response will enter into the long-term follow-up phase of the protocol and may be eligible for re-treatment at the time of disease progression. Patients will be monitored every 2 months until disease progression or for 2 years, whichever comes first.