A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

- Histologically confirmed diagnosis of RCC with clear cell component

- Measurable disease

- Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have
become intolerant to a systemic therapy

- Subjects with treated brain metastases must be without magnetic resonance imaging
(MRI) evidence of progression for at least 8 weeks and off steroids for at least 4
weeks to be eligible

- At least 28 days since the last chemotherapy

- At least 28 days before the first dose of MDX 1411 since any major surgery

- ECOG performance status 0-2

- No known positivity for human immunodeficiency virus (HIV), Hep B or C

Exclusion Criteria:

- Previous treatment with any other anti-CD70 antibody

- Active infection requiring i.v systemic therapy within 28 days before first dose

- Evidence of bleeding diathesis or coagulopathy

- Active autoimmune disease requiring immunosuppressive therapy

- Known current drug or alcohol abuse

- Any underlying medical condition which will make the administration of MDX 1411
hazardous

- Psychiatric illness or social situation that would preclude study compliance