Extension Study for Participants in Studies That Include Belzutifan

• Research type

  Research Study

• Full title

  A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

• IRAS ID

  1013259

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07405164

• Research summary

  Researchers are looking for new ways to treat advanced solid tumours and von Hippel-Lindau (VHL)-related tumours:
  • Advanced means the cancer has spread to other parts of the body or cannot be removed with surgery
  • Solid tumours are cancers mostly in body organs and tissues
  • VHL-related tumours are tumours caused by VHL disease

  Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan is designed to block a protein that helps tumours grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (parent trials) may be able to join.

  The goal of this trial is to learn how long people live after they start taking belzutifan.

  People can take part in the trial if they meet certain criteria, including if they:
  • Are receiving treatment as a participant in a parent trial of belzutifan
  • Have certain solid tumours or VHL-related tumours
  • Do not have certain health problems

  People will receive the same dose of each treatment that they received during their parent trial.

  This trial has 3 treatment groups. Researchers will assign people to one of these treatment groups:
  • Group A: People who received only belzutifan in their parent trial
  • Group B: People who received belzutifan with palbociclib, nivolumab, lenvatinib, or cabozantinib in their parent trial
  • Group C: People who did not receive belzutifan in their parent trial, but received a different treatment such as lenvatinib, cabozantinib, or everolimus
  Note – Palbociclib and everolimus will not be used in the UK

  Both the people in the trial and researchers will know which trial treatment a person is getting.
  A person may be in this trial for about 7 years.

  During the trial, people may:
  • Give urine and blood samples
  • Have physical examinations
  • Have tests to check their heart

• REC name

  Wales REC 1

• REC reference

  26/WA/0018

• Date of REC Opinion

  25 Mar 2026

• REC opinion

  Further Information Favourable Opinion