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

Trial ID: NCT04736706
Kidney Cancer Type: Clear Cell Component Required

Lenvatinib (Lenvima®) is a type of tyrosine kinase inhibitor (TKI) that prevents the growth of cancer cells by blocking the formation of new blood vessels in tumours. It is similar to other approved medications such as Sunitinib (Sutent®) or Axitinib (Inlyta®).

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 Lenvatinib and Pembrolizumab, compared to Lenvatinib and Pembrolizumab administered without Belzutifan.

Participants will be randomly assigned to one of the treatment regimens. This trial is not “blind”, so both you and your doctor will know which therapy you are receiving.

Basic Eligibility:

  • Advanced kidney cancer with a clear-cell component
  • 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 StatusActive, not recruiting
Hospital / Cancer CentreTom Baker Cancer Centre Principal InvestigatorNot Given LocationCalgary, AB Trial StatusActive, not recruiting
Hospital / Cancer CentreJuravinski Cancer Centre Principal InvestigatorNot Given LocationHamilton, ON Trial StatusActive, not recruiting
Hospital / Cancer CentreSunnybrook Research Institute Principal InvestigatorNot Given LocationToronto, ON Trial StatusActive, not recruiting
Hospital / Cancer CentreCentre intégré de cancérologie du CHU de Québec Université Laval Principal InvestigatorNot Given LocationQuebec City, QC Trial StatusActive, not recruiting
Kidney Cancer Canada