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)
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.
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.
i. The biopsy or resection was performed within 1 year of registration AND
a. Prior systemic therapy for advanced or metastatic RCC.
b. Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred within 12 months of last dose of such therapy. Treatment with an immune checkpoint inhibitor in the adjuvant setting is allowed providing more than 12 months have elapsed since last dose or completion of therapy.
c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways).
d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).