A Study of Different Immune and Targeted Therapies for 1st Line Treatment of Kidney Cancer (Substudy 03A)

Trial ID: NCT04626479
Kidney Cancer Type: Clear Cell Only


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

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®).

In this trial, researchers will combine these approved treatments with several experimental anti-cancer drugs to see if they are more effective than either treatment alone:

  • Favezelimab –  Targets a new anti-cancer target called LAG-3
  • Bezultifan – Targets a new anti-cancer target called HIF-2-alpha
  • Quavonlimab – Targets the established anti-cancer target: CTLA-4


The Trial:

This study will investigate the safety and effectiveness of approved anti-cancer therapies in a number of different combinations to identify if any combinations have a significant advantage over single-agent administration.

Accordingly, you may be randomly enrolled in any one of four treatment groups:

  • Pembrolizumab + Quavonlimab + Lenvatinib
  • Favezelimab + Pembrolizumab+ Lenvatinib
  • Pembrolizumab + Belzutifan + Lenvatinib
  • Pembrolizumab + Lenvatinib
  • Pembrolizumab + Vibostolimab + Belzutifan

Basic Eligibility:

  • Clear cell kidney cancer
  • Cancer has spread or cannot be removed by surgery
  • No prior systemic therapies are permitted

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


Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentrePrincess Margaret Cancer Centre Principal InvestigatorNot Given LocationToronto, ON Trial StatusRecruiting
Hospital / Cancer CentreJewish General Hospital Principal InvestigatorNot Given LocationMontreal, QC Trial StatusRecruiting
Kidney Cancer Canada