A Study of Pembrolizumab in Combination with Stereotactic Body Radiation Therapy (SBRT) in Patients Who Have Completed Tyrosine Kinase Inhibitor (TKI) Therapy (OZM-065)

Trial ID: NCT02599779
Kidney Cancer Type: Clear cell component


This study involves combining drug therapy with a form of radiation therapy.

The drug used in this study is called Pembrolizumab (Keytruda®). It is an immunotherapy drug that works by reactivating the body’s own immune response to target and destroy cancer cells. It is currently Health Canada-approved for the treatment of kidney cancer in combination with another drug, called Axitinib (INLYTA®).

Stereotactic Body Radiation Therapy (SBRT) is used to treat cancers using substantially higher doses of radiation than conventional radiotherapy, while limiting the dose of radiation to nearby normal tissues. SBRT is commonly employed in cancers of the lung, liver, and pancreas, where it is used to shrink tumours that have spread to other parts of the body.

Combining these treatment options may result in an improved response to therapy.

The Trial:

The purpose of this trial is to explore the safety and effectiveness of combining pembrolizumab with SBRT for the treatment of kidney cancer. SBRT will be administered to the 1-3 largest metastatic tumours in an effort to improve the effectiveness of pembrolizumab.

This trial is for patients with stage 4 metastatic kidney cancer. Specifically, patients who have stopped responding to their prior therapy with a tyrosine kinase inhibitor (TKI; such as Sunitinib, etc.)

Basic Eligibility:

  • All kidney cancer subtypes are eligible
  • Must have at least 1-3 metastatic tumours that have spread beyond the kidney
  • Must have received and subsequently stopped responding to a TKI therapy
    • (i.e. Sunitinib (Sutent®), Pazopanib (Votrient®), Axitinib (Inlyta®))

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

Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentreTom Baker Cancer Centre Principal InvestigatorDr Richard Lee-Ying LocationCalgary, AB Trial StatusRecruiting
Hospital / Cancer CentrePrincess Margaret Hospital Principal InvestigatorDr Aaron Hansen LocationToronto, ON Trial StatusRecruiting
Hospital / Cancer CentreSunnybrook Health Sciences Centre Principal InvestigatorDr Georg Bjarnason LocationToronto, ON Trial StatusRecruiting
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