Full Title
A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) (SAMETA) (WIRB)Purpose
The purpose of this study is to compare the effectiveness of treatment with savolitinib plus durvalumab versus durvalumab alone or sunitinib alone as initial treatment in people with inoperable or metastatic papillary renal cell (kidney) cancer whose growth is fueled by a protein called MET. Participants will be randomly assigned to receive one of these treatments:
- Savolitinib and durvalumab (half of the patients)
- Durvalumab alone (one-fourth of the patients)
- Sunitinib alone (one-fourth of the patients)
Participants receiving durvalumab alone who experience continued growth of their cancer may be able to receive savolitinib plus durvalumab. Savolitinib and sunitinib are taken orally (by mouth) and durvalumab is given intravenously (by vein).
Eligibility
To be eligible for this study, patients must meet several requirements, including:
- Participants must have inoperable, locally advanced, or metastatic papillary renal cell carcinoma and may not have received treatment for advanced cancer.
- Patients’ cancer growth must be driven by the MET protein.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Chung-Han Lee at 646-888-5418.