drugset / Trial / NCT02608385

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

NCT02608385 ↗

Phase 1 Active not recruiting 117 enrolled University of Chicago
Non-randomizedSequentialOpen-labelTreatment

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)

Timeline

Start
2015-12
Primary completion
2022-04-01
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg —

Indications