Belzutifan + Zanzalintinib versus Cabozantinib for Advanced RCC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

• IRAS ID

  1011802

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07227402

• Research summary

  Researchers are looking for more ways to treat recurrent advanced renal cell carcinoma (RCC). RCC is a type of kidney cancer. Advanced means the cancer cannot be completely removed by surgery or has spread to other parts of the body. Recurrent means the cancer came back after treatment.

  Current treatment for recurrent advanced RCC may include cabozantinib. Cabozantinib is a targeted therapy, which works to control how specific types of cancer cells grow and spread. However, it does not work for everyone with recurrent advanced RCC.

  The trial treatments, belzutifan and zanzalintinib, are different targeted therapies.

  The goal of this trial is to learn if people who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.

  About 904 people with recurrent advanced RCC aged 18 years or older can take part in the trial if they:
  • Have had the cancer get worse during or after they received certain treatments
  • Do not have certain health conditions

  Researchers will assign people by equal chance to one of these groups:
  Group A - Belzutifan and zanzalintinib
  Group B - Cabozantinib
  All treatment will be taken by mouth as tablets once a day.

  People will take their treatments up to about 2 years or until:
  • The cancer gets worse
  • The person or their trial doctor decides to end treatment, or
  • The trial ends

  Both the people in the trial and the researchers will know which trial treatment a person is getting.

  During the trial, people may:
  • Give urine and blood samples
  • Have tumour and imaging tests
  • Have physical examinations
  • Answer questions about how they are feeling
  • Have tests to check their heart (electrocardiograms or ECGs)

• REC name

  Wales REC 1

• REC reference

  26/WA/0101

• Date of REC Opinion

  18 May 2026

• REC opinion

  Further Information Favourable Opinion