Study on Belzutifan with Palbociclib vs. Belzutifan Alone for Advanced Kidney Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05468697

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment using belzutifan alone or in combination with palbociclib for patients with advanced kidney cancer that has worsened after previous treatments.

Patient Parameters

Program Overview

The study aims to find out if belzutifan, either by itself or combined with palbociclib, can help treat advanced clear-cell renal cell carcinoma (ccRCC) in patients whose cancer has progressed after other treatments. In the first part of the study, researchers will determine the safest dose of palbociclib to use with belzutifan. In the second part, they will evaluate how well this combination works and its safety at the chosen dose.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced Stage IV kidney cancer that cannot be surgically removed, with a clear-cell component.
  • Cancer has worsened after receiving at least two previous treatments, including a PD-1/L1 inhibitor and a VEGF-TKI, either separately or together.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have recovered from any side effects of previous treatments.

Exclusion Criteria

  • Have low oxygen levels or need supplemental oxygen.
  • Have another active cancer that has required treatment in the past 3 years.
  • Have cancer that has spread to the brain or spinal cord.
  • Have significant heart disease.
  • Have moderate to severe liver problems.
  • Have a history of HIV infection.
  • Have a history of hepatitis B or active hepatitis C infection.
  • Have previously been treated with belzutifan or palbociclib.
  • Have had radiation therapy within 2 weeks before starting the study treatment and have not fully recovered.
  • Have had major surgery within 3 weeks before starting the study treatment.
  • Have received certain growth factors within 28 days before starting the study treatment.

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