Renal Cell Carcinoma
|Recruiting||Kidney Cancer||Phase III||
The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.
- 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%
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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