NCT07123090

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Stephanie Berg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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.

Conditions

• Metastatic Renal Cell Carcinoma
• Metastatic Renal Cancer
• Renal Cell Carcinoma
• Advanced Clear Cell Renal Cell Carcinoma
• Kidney Cancer
• Translocation Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sasanlimab	Recombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol
DRUG	Palbociclib	Cyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol
DRUG	Axitinib	Vascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-10-01
• Completion: 2028-02-01
• First posted: 2025-08-14
• Last updated: 2026-03-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study