Phase 2 Study of Sasanlimab, Palbociclib, and Axitinib for Advanced Kidney Cancer

Sponsor: Stephanie Berg

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07123090

Provider View

This study is testing a combination of three drugs—sasanlimab, palbociclib, and axitinib—to see how well they work and how safe they are for treating advanced kidney cancer. The study focuses on two types of kidney cancer: clear cell renal cell carcinoma and translocation renal cell carcinoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of three drugs—sasanlimab, palbociclib, and axitinib—in treating advanced kidney cancer. Sasanlimab is a monoclonal antibody, palbociclib is a kinase inhibitor, and axitinib is a vascular endothelial growth factor inhibitor. The study will involve about 25 participants who will undergo various procedures, including medical tests and scans, to monitor their health and the treatment's effects.

Description

This Phase 2 study is designed to test how well and safely the drugs sasanlimab, palbociclib, and axitinib work together for treating advanced kidney cancer. While axitinib is approved for treating clear cell renal cell carcinoma, the combination of these three drugs is not yet approved for this type of cancer. Participants will go through a series of procedures, including eligibility screening, clinic visits, and various tests like blood and urine tests, imaging scans, and heart monitoring. Pfizer is supporting this study by providing the drugs and funding. The study aims to gather data on how these drugs work together and their safety profile.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic kidney cancer with a clear cell component or translocation renal cell carcinoma.
  • Be 18 years or older.
  • Have measurable disease according to specific medical criteria.
  • Be in good overall health with a performance status score of 2 or less.
  • Have normal organ and bone marrow function based on specific blood test results.
  • Women and men must agree to use effective birth control during the study and for 90 days after the last dose of the study drugs.
  • Be able to swallow pills.
  • Understand and agree to sign a consent form to participate in the study.

Exclusion Criteria

  • Have received prior treatment for advanced or metastatic kidney cancer.
  • Have untreated brain metastases or recent brain surgery or radiation.
  • Have had major surgery within the last four weeks.
  • Have serious or uncontrolled medical conditions that could interfere with the study.
  • Be currently using immunosuppressive medications, except for certain low-dose steroids.
  • Have a history of severe allergic reactions to similar drugs.
  • Have active autoimmune diseases that could worsen with the study drugs.
  • Have had a recent vaccination with a live vaccine.
  • Have active infections or known viral infections like HIV or active Hepatitis B or C.
  • Have had a stem cell or organ transplant.
  • Have gastrointestinal issues that affect drug absorption.
  • Be taking certain medications that interact with the study drugs.
  • Be pregnant or breastfeeding.
  • Be judged by the investigator as unsuitable for the study.

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