Study of BMS-936558 vs. Everolimus in Pre-Treated Advanced Or Metastatic Clear-cell RCC
Status: Recruiting
Phase: Phase 3
Diagnosis: Kidney Cancer
NCT ID: NCT01668784
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-465
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
Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
David McDermott, MD,
Beth Israel Deaconess Medical Center
Site-responsible Investigators:
Toni Choueiri, MD,
Dana-Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Judith Prisby, 617-632-5068,
jprisby@partners.org
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
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