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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03313804
Other study ID # MCC-17-MULTI-20-PMC
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 26, 2017
Est. completion date February 2025

Study information

Verified date April 2024
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Subjects with front-line or relapsed NSCLC or relapsed HNSCC who are intended to receive standard of care immune checkpoint inhibitors without a contraindication to Stereotactic Body Radiation Therapy (SBRT) to a single cancer deposit greater than 1 cm (metastasis or primary cancer) will be enrolled. Subjects will receive standard of care (SOC) immune checkpoint inhibitors and within 2 weeks of initiation, and will receive either: - SBRT to target to achieve Biological Equivalent Dose (BED) > 100 Gy OR - 30 Gy fractionated radiation therapy (RT) delivered as a 3 dimensional (3-D) dose. The lesion choice will be made by the treating radiation oncologist and will be directed to a single malignant focus (non-CNS) that measures ≥ 1 cm. Essentially, the goals of both techniques are the same but SBRT is reserved for lesions that are readily encompassed by a single field with large RT fractions in which dose-limiting organs are within safe limits.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Immune checkpoint inhibitor
Standard of care immune checkpoint inhibitor
Radiation:
Radiation Therapy
Stereotactic Body Radiation Therapy OR Fractionated radiation therapy

Locations

Country Name City State
United States University of Kentucky Markey Cancer Center Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
John L. Villano, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary study endpoint is 6-month progression-free survival. Progression-free survival will be calculated as time from enrollment in the study to progression at 6-months post enrollment. 6-months post enrollment
Secondary Percentage of (programmed death) PD-1+ CD4+ T (helper) cells and PD-1+ CD8+ T (cytotoxic) cells prior to treatment versus with concurrent treatment. Assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 years
Secondary Percentage of CD8+ T-cells that are gamma-interferon positive during treatment. Assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 years
Secondary Percentage PD-L1+ CD4+ and PD-L1+ CD8+ T-cell expression differences during treatment Assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 years
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