A Study of Belzutifan + Pembrolizumab versus Pembrolizumab Alone for Patients with Advanced Kidney Cancer

Trial ID: NCT05239728
Kidney Cancer Type: Clear Cell Component Required

Pembrolizumab (Keytruda®) is an immunotherapy drug that is already approved for the treatment of kidney cancer in Canada. It works by targeting a molecule called PD-1 to reactivate the body’s own immune response to target and destroy cancer cells.

Belzutifan (Welireg®) is a drug that is currently used for patients with an inherited genetic condition called von Hippel-Lindau (VHL) disease. The VHL gene is also found to be damaged in over 50% of patients with advanced kidney cancer. This drug works by blocking a molecule called HIF-2α, which may prevent tumours from growing new blood vessels and obtaining the nutrients they need to grow.

The Trial:
This study will investigate the safety and effectiveness of Belzutifan in combination with Pembrolizumab, compared to Pembrolizumab administered alongside a placebo.

A placebo group ensures that any perceived benefit derived from Belzutifan is conclusively related to this new drug, rather than the standard-of-care option, Pembrolizumab. Remember that in a clinical trial, there is no guarantee that the new drug will perform better than the current standard of care.

The study enrollment will be randomized and blinded, which means that neither you, nor your doctors, will know whether you are receiving Belzutifan or Placebo.

Basic Eligibility:

  • Advanced kidney cancer with a clear-cell component
  • Must have undergone a nephrectomy prior to treatment
  • Must not have received any prior therapies (incl. chemotherapies, immunotherapies, or radiation)

Additional eligibility criteria will apply. Please speak to your doctor.

Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentreBC Cancer Principal InvestigatorNot Given LocationVancouver, BC Trial StatusRecruiting
Hospital / Cancer CentreTom Baker Cancer Center Principal InvestigatorNot Given LocationCalgary, AB Trial StatusRecruiting
Hospital / Cancer CentreJuravinski Cancer Centre Principal InvestigatorNot Given LocationHamilton, ON Trial StatusRecruiting
Hospital / Cancer CentreVictoria Hospital & Children's Hospital Principal InvestigatorNot Given LocationLondon, ON Trial StatusRecruiting
Hospital / Cancer CentrePrincess Margaret Cancer Centre Principal InvestigatorNot Given LocationToronto, ON Trial StatusRecruiting
Hospital / Cancer CentreCIUSSS de l'Est-de-l'Île-de-Montréal Principal InvestigatorNot Given LocationMontréal, QC Trial StatusRecruiting
Hospital / Cancer CentreMcGill University Health Centre (MUHC) Principal InvestigatorNot Given LocationMontréal, QC Trial StatusRecruiting
Hospital / Cancer CentreCentre intégré de cancérologie du CHU de Québec Université Laval Principal InvestigatorNot Given LocationVille de Québec, QC Trial StatusRecruiting
Kidney Cancer Canada