A phase II multicenter study of lenvatinib plus everolimus versus cabozantinib in patients with metastatic renal cell carcinoma that progressed on a PD-1/PD-L1 checkpoint inhibitor

UVA Tracking #
HSR220466
Principal Investigator
William Paul Skelton Iv
Contact
Contact Phone
Official Trial Title
A phase II multicenter study of lenvatinib plus everolimus versus cabozantinib in patients withmetastatic renal cell carcinoma that progressed on a PD-1/PD-L1 checkpoint inhibitor (LenCabo).
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with metastatic renal cell carcinoma who have received 1-2 prior forms of treatment for this disease for a research study. The most recent form of treatment must have included a PD-1/PD-L1 checkpoint inhibitor. The purpose of the study is to compare the effectiveness of two different FDA-approved treatments: lenvatinib plus everolimus, and cabozantinib. The treatment that you will receive will be randomly assigned, and both you and the study doctor will know what treatment group you are a part of.

All of the study drugs are given as pills and will be taken orally (by mouth) once daily. You will visit the clinic for a study visit once per month, where you will undergo routine/usual care assessments including physical exams and blood sampling during each visit. You may also be required to complete tests during your visit such as a CT (computerized tomography) scan, MRI (magnetic resonance imaging), or ECHO (echocardiogram) to check on the status of your cancer. Information from these assessments will be recorded for research purposes.

The duration of your overall participation in the study is based on how well you tolerate the study drug(s). You can take the study drug(s) for as long as the study doctor believes it is beneficial to you.

All study-related procedures are considered standard of care practices, so the participant/participant’s insurance company will be billed for all medication, tests and procedures.”

Compensation

No Compensation