Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

Summary

This is a single-arm phase II trial evaluating the combination of avastin and temsirolimus in patients with metastatic renal cell cancer (RCC) including both histologically confirmed clear cell (cc) or non-clear cell (ncc) subtypes. Patients must have experienced disease progression or intolerable toxicity with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) (e.g. sorafenib, sunitinib, pazopanib). Only 2 prior VEGF therapies are allowed. The purpose of this research study is to evaluate efficacy of the combination against an historical control. Temsirolimus has been approved by the Food and Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been approved by the FDA for other types of cancers but not renal cell carcinoma.

Timeline

Start

2009-04

Primary completion

2015-05

Completion

2015-05

Publications

• Results Mahoney KM, Jacobus S, Bhatt RS, Song J, Carvo I, Cheng SC, Simpson M, Fay AP, Puzanov I, Michaelson MD, Atkins MB, McDermott DF, Signoretti S, Choueiri TK. Phase 2 Study of Bevacizumab and Temsirolimus After VEGFR TKI in Metastatic Renal Cell Carcinoma. Clin Genitourin Cancer. 2016 Aug;14(4):304-313.e6. doi: 10.1016/j.clgc.2016.02.007. Epub 2016 Feb 23.

Drugs

Indications