Stephanie Berg
The goal of this research 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 name of the study drugs involved in this research study is: * Sasanlimab (a type of monoclonal antibody) * Palbociclib (a type of kinase inhibitor) * Axitinib (a type of Vascular endothelial growth factor inhibitor)
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 s…
Inclusion Criteria: * Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible. * a. For tRCC please refer to the following for eligibility definitions: * i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable. * ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded. * b. A formalin-fixed,…
Recombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol
Cyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol
Vascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care
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