NCT03431948

Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer

Platform Phase 1 Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Immuno-oncology Agents for the Treatment of Multiple Metastases in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to determine the best dose of stereotactic body radiation therapy (SBRT) to be administered in combination with immunotherapy drugs including urelumab, cabiralizumab and nivolumab .

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240 mg given by intravenous infusion every 2 weeks
DRUG	Cabiralizumab	Cabiralizumab 4 mg/kg given by intravenous infusion every 2 weeks
DRUG	Urelumab	Urelumab 8 mg given by intravenous infusion every 4 weeks
RADIATION	Stereotactic Body Radiation Therapy	Radiation to metastatic lesion(s) given at assigned dose levels based on lesion location and dose level being tested at time of enrollment. Doses range from 30 - 50 Gy.

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-02-29
• Completion: 2022-04-11
• First posted: 2018-02-13
• Last updated: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study