NCT02608385

Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors

Phase I Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I to determine safety of combining stereotactic body radiotherapy (SBRT) with pembrolizumab in patients with advanced solid tumors. The study will determine safe doses of radiation by organ site when used together with pembrolizumab. The study will also provide the opportunity to evaluate changes in the tumor caused by SBRT. The study will include 2 expansion cohorts: * Partially Irradiated Large Volume Tumors Cohort: Patients with at least one lesion greater than 65cc amenable to SBRT followed by pembrolizumab. * Oligometastatic Cohort: Patients with limited metastatic disease (4 or fewer lesions)

Conditions

• Solid Tumor

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiotherapy (SBRT)	Patients will receive 3 or 5 doses of SBRT to the chosen metastases.
DRUG	Pembrolizumab	Pembrolizumab (200 mg) given every 3 weeks.

Timeline

• Start date: 2015-12-01
• Primary completion: 2022-04-01
• Completion: 2026-11-01
• First posted: 2015-11-18
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States