NCT02978404

Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 radiotherapy. 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.

Conditions

• Clear-Cell Metastatic Renal Cell Carcinoma
• Non Small Cell Lung Cancer Metastatic
• Brain Metastases, Adult
• Small Cell Lung Cancer
• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is administered to patients to a maximum of 2 year.
RADIATION	Radiosurgery	Up to 10 cubic centimeter of brain metastases will be treated with radiosurgery. The dose of radiosurgery depends on the size of individual metastases.

Timeline

• Start date: 2017-06-02
• Primary completion: 2021-01-31
• Completion: 2023-12-31
• First posted: 2016-12-01
• Last updated: 2024-06-28

Locations

4 sites across 1 country: Canada