drugset / Trial / NCT03313804

Priming Immunotherapy in Advanced Disease With Radiation

NCT03313804

Phase 2 Completed 76 enrolled John L. Villano, MD, PhD
NaSingle-groupOpen-labelTreatment

Summary

This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA approved guidelines. In these patients we will deliver a short-course radiation to a single systemic (non-CNS) site within 14 days of receiving the first dose of immune checkpoint inhibitors. This sequence allows radiation to release tumor antigens from immune inaccessible areas such as necrotic tumor or low perfusion to provide a robust anti-tumor immune response with immune checkpoint inhibitors. The primary objective is to assess six-month progression free survival (PFS) compared to historical control.

Timeline

Start
2017-10-26
Primary completion
2024-02-16
Completion
2026-02-16

Drugs

EvaluationDrugModalityDoseRoute
Background Atezolizumab Monoclonal antibody
Background Nivolumab Monoclonal antibody
Background Pembrolizumab Monoclonal antibody