Phase 2 Study of Sasanlimab, Palbociclib, and Axitinib for Advanced or Metastatic Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating how well and safely the drugs sasanlimab, palbociclib, and axitinib work for treating people with advanced clear cell renal cell carcinoma ccRCC or translocation renal cell carcinoma tRCC. This Phase 2 study focuses on these advanced kidney cancers, with sasanlimab and palbociclib being investigational for this use, while axitinib is an approved treatment for ccRCC. The combination of all three drugs is not yet approved for these conditions. Participants will receive a combination of three drugs sasanlimab by injection under the skin daily starting Day 1 axitinib tablets twice daily starting Day 1 and palbociclib tablets once daily starting Day 8 through Day 28 of each 28-day treatment cycle. The study includes a baseline visit, imaging every 8 weeks for 16 weeks, then every 12 weeks, and an end of treatment visit. After treatment ends, participants will be followed up every 6 months for 2 years. Participants will have screening and regular visits including questionnaires, blood and urine tests, imaging scans, and heart monitoring with electrocardiograms. Disease status will be assessed every 8 weeks initially, then every 12 weeks, to track tumor response. Safety is monitored throughout treatment and for 90 days after the last dose. Survival follow-up will continue every 6 months for up to 2 years. The total treatment duration can be up to 14 months, with close monitoring during and after therapy.

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