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Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect

NCT03825510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-03-06

No results posted yet for this study

Summary

The purpose of this study is to determine efficacy, safety of Stereotactic Body Radiotherapy (SBRT) in combination with immunotherapy in participants with metastatic non-small cell lung cancer (NSCLC) who are eligible for an immunotherapy agent.

Conditions

  • Metastatic Nonsmall Cell Lung Cancer
  • Non Small Cell Lung Cancer

Interventions

RADIATION

Stereotactic Body Radiotherapy

All patients in this trial will be treated with fractionated Stereotactic body radiation therapy. SBRT will be delivered to \<=3 sites in 3-5 fractions followed by administration of the specified immunotherapy agent (Nivolumab or Pembrolizumab). This approach will take advantage of the transient increase in antigen availability, increased antigen presentation and upregulation of PD-1 by tumor cells following ablative radiation therapy.

Sponsors & Collaborators

  • Saint Peters University Hospital

    collaborator OTHER

  • Community Medical Center, Toms River, NJ

    collaborator OTHER

  • Crozer-Keystone Health System

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2022-03-08
Completion
2022-03-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825510 on ClinicalTrials.gov