CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Immune checkpoint inhibitor +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03313804
NCT03313804Phase 2Completed

Priming Immunotherapy in Advanced Disease With Radiation

John L. Villano, MD, PhD·interventional·Posted Oct 18, 2017·Updated Mar 11, 2026

In Brief

A Phase 2 clinical trial evaluating Immune checkpoint inhibitor and Radiation Therapy for Non-small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 18, 2017
Enrollment StartOct 26, 2017
Primary CompletionFeb 16, 2024
Study CompletionFeb 16, 2026
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 8.7 years ago

Interventions

Immune checkpoint inhibitordrug

Standard of care immune checkpoint inhibitor

Radiation Therapyradiation

Stereotactic Body Radiation Therapy OR Fractionated radiation therapy