Study on Belzutifan for Advanced Kidney Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04489771

Provider View

This clinical trial is testing two different doses of the drug belzutifan to see which is more effective in treating advanced kidney cancer with a clear cell component. The study aims to find out if the higher dose of belzutifan works better than the standard dose in shrinking tumors.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness and safety of two doses of belzutifan in patients with advanced kidney cancer that has a clear cell component. Researchers want to see if the higher dose of belzutifan is better at reducing tumors compared to the standard dose.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced kidney cancer with a clear cell component.
  • Have measurable cancer as determined by specific medical criteria.
  • Able to provide a tumor sample for analysis.
  • Cancer has worsened after previous treatment with specific immune therapies.
  • Have received no more than three prior treatments for advanced kidney cancer.
  • Have only received one prior immune therapy for advanced kidney cancer.
  • Have recovered from side effects of previous treatments to a mild level.
  • Have a performance status score of at least 70%, indicating the ability to care for oneself.
  • Male participants must agree to use contraception or abstain from sex during the study and for at least 7 days after the last dose.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for at least 30 days after the last dose.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.

Exclusion Criteria

  • Have low oxygen levels or need oxygen therapy.
  • Have another progressing cancer or have been treated for another cancer in the past 3 years, except for certain skin cancers or in situ cancers.
  • Have cancer that has spread to the brain or spinal cord.
  • Have significant heart disease or recent heart attack.
  • Have moderate to severe liver problems.
  • Have used certain growth factors within 28 days before starting the study.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Cannot swallow pills or have digestive issues affecting absorption.
  • Have allergies to belzutifan or its components.
  • Have previously been treated with belzutifan or similar drugs.
  • Have used certain cancer treatments or participated in another study recently.
  • Have an active infection or tuberculosis.
  • Have an immune deficiency or history of HIV, hepatitis B, or hepatitis C.
  • Have any condition or treatment that might interfere with the study or not be in the participant's best interest.

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