A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma

Description

This single arm, Phase 2 study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).

The U.S. Food and Drug Administration (FDA) has not approved sasanlimab or palbociclib as a treatment option for ccRCC or tRCC.

The U.S. FDA has approved axitinib as a treatment option for ccRCC.

The U.S. FDA has not approved the combination of sasanlimab, axitinib, and palbociclib for ccRCC or tRCC.

The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, imaging scans, and electrocardiograms (ECGs).

It is expected that about 25 people will take part in this research study.

Pfizer, is supporting this research study by providing funding and the study drugs, sasanlimab, palbociclib, and axitinib.