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).
Single group
Sasanlimab
DrugRecombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol
Palbociclib
DrugCyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol
Axitinib
DrugVascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care
Objective Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Grade 3 or Higher Treatment-Related Adverse Event (AE) Rate
The percentage of participants who experienced a grade 3 or higher treatment-related AE based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms. Treatment-related AEs are defined as those rated 'Possibly", "Probably", or "Definitely" related to any of the study drugs.
Complete Response Rate (CRR)
CRR is defined as the percentage of participants achieving complete response (CR) based on RECIST 1.1 criteria. Per RECIST 1.1, CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and absence of new lesions.
Deep Partial Response Rate
Deep partial response rate is defined as the percentage of participants achieving deep partial response based on RECIST 1.1. Deep partial response is defined as ≥80% reduction in target lesions by central review.
Median Progression-Free Survival (PFS)
PFS based on Kaplan-Meier method is defined as the time from protocol treatment initiation to the earlier of progression or death due to any cause. Participants alive without PD are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
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