Belzutifan + Zanzalintinib vs Belzutifan for RCC

• Research type

  Research Study

• Full title

  Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)

• IRAS ID

  1011803

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07489495

• Research summary

  Researchers are looking for new and better ways to treat advanced renal cell carcinoma (RCC), a type of kidney cancer. One treatment sometimes used is belzutifan, a trial medicine that works as a targeted therapy. Targeted therapies focus on specific changes in cancer cells to help slow down or stop their growth. Researchers now want to find out if combining belzutifan with another targeted therapy called zanzalintinib can help more participants than using belzutifan on its own.

  The purpose of this trial is to see whether participants who take belzutifan plus zanzalintinib live longer overall, and live longer without their cancer getting worse, compared with participants who take belzutifan plus a placebo. A placebo looks like trial medicine but has no active treatment.

  About 758 adults will take part.
  To join, participants must:
  • Be at least 18 years old
  • Have the most common type of RCC called clear cell RCC
  • Have had their cancer get worse during or after certain treatments for RCC
  • Not have certain heart or lung problems

  Participants will take two tablets once a day.
  These may include belzutifan, zanzalintinib, or placebo. Participants will be randomly assigned-like flipping a coin - to one of two groups:
  • Group 1: Belzutifan and zanzalintinib
  • Group 2: Belzutifan and placebo

  Participants will continue taking their trial medicines until the cancer gets worse, they experience side effects they cannot tolerate, or they or the researchers choose to stop treatment.

  This is a double-blind trial, which means neither the participants nor the researchers will know which medicines each person is taking.
  Throughout the trial, participants will:
  • Give blood and urine samples
  • Have tumour scans and heart tests.
  • Have physical exams
  • Answer questions about their health and well-being.
  Participants may be in the trial for up to 5 years, including follow-up.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  26/SC/0042

• Date of REC Opinion

  29 Apr 2026

• REC opinion

  Further Information Favourable Opinion