A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
NCT07123090 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-03-25
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)
Conditions
- Metastatic Renal Cell Carcinoma
- Metastatic Renal Cancer
- Renal Cell Carcinoma
- Advanced Clear Cell Renal Cell Carcinoma
- Kidney Cancer
- Translocation Renal Cell Carcinoma
Interventions
- DRUG
-
Recombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol
- DRUG
-
Cyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol
- DRUG
-
Vascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care
Sponsors & Collaborators
- collaborator INDUSTRY
-
Stephanie Berg
lead OTHER
Principal Investigators
-
Stephanie Berg, DO · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-24
- Primary Completion
- 2026-10-01
- Completion
- 2028-02-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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