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

Excluded: TFEB amplification

TFEB amplified tumors are excluded.

Allowed: TFE3 translocation

TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable.

Allowed: TFEB rearrangement

TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded.

Cannot have received: systemic therapy

Prior systemic therapy for advanced or metastatic RCC

Cannot have received: adjuvant or neoadjuvant therapy

Exception: allowed if >12 months since last dose; immune checkpoint inhibitor in adjuvant setting allowed if >12 months since last dose

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.

Cannot have received: immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4)

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)

Cannot have received: VEGF pathway inhibitor (axitinib)

Exception: adjuvant therapy is allowed

Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).

Cannot have received: CDK4/6 inhibitor

Prior therapy with any CDK4/6 inhibitor.