Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases

Official Title

A Phase II, Multi-centre Study, of Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases From Non-small Cell Lung Cancer and Renal Cell Cancer


Stereotactic radiosurgery (SRS) is increasingly administered as the sole treatment of brain metastases, in order to spare acute and long term side effects associated with whole brain radiation therapy. Local control of SRS treated lesions is good, but patients tend to develop additional brain metastases subsequently. Nivolumab is a modulator of the immune system. Treatment with Nivolumab is associated with an increase in local control and survival in patients with non-small cell lung cancer and clear cell renal cell carcinoma. In the presence of Nivolumab, treatment of brain metastases with SRS may trigger an immune reaction against cancer. Therefore, the combination of SRS with Nivolumab may reduce the development of new brain metastases and improve patient survival. The purpose of this study is to assess the effect of combining Nivolumab and SRS in controlling cancer progression. SRS will be administered to patients while they are receiving Nivolumab.

Trial Description

Primary Outcome:

  • Intracranial progression-free survival
Secondary Outcome:
  • Treated brain lesions control rate
  • Overall survival after receiving Nivolumab.
  • Maximum response rate of distant non-irradiated disease
  • Progression-free survival
  • Correlation between tumour PD-L1 expression and clinical outcomes
  • Patient quality of life
  • Neurocognitive function, as measured by the HVLT-R
  • Neurocognitive function, as measured by TMT
  • Neurocognitive function, as measured by COWA
  • Acute and late toxicity of SRS + Nivolumab
  • Imaging indicators of response

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Canadian Cancer Society

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