A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

- Men & women ≥ 18 years of age

- Histologic confirmation of Renal cell carcinoma (RCC) with clear-cell component

- Advanced/metastatic RCC

- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
criteria

- Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic
setting

- No more than 3 total prior systemic treatment regimens in the advanced or metastatic
setting, and evidence of progression on or after last treatment regimen received and
within 6 months of enrollment

- Karnofsky Performance Score ≥ 70%

Exclusion Criteria:

- Any Central Nervous System (CNS) metastases or history of CNS metastases

- Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor

- Any active known or suspected autoimmune disease.

- Uncontrolled adrenal insufficiency

- Active chronic liver disease

- Prior malignancy active within past 3 years, except for locally curable cancers