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UCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC.

NCT03224871 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-04-07

No results posted yet for this study

Summary

The advent of checkpoint blockade immunotherapy has revolutionized the management of metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and durable responses with these agents the majority of patients fail to respond. The investigators hypothesize that a novel strategy combining radiotherapy and intralesional interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade therapy and offer significant clinical benefit to patients who fail to respond to checkpoint blockade alone. The investigators propose a microtrial testing the feasibility of a bold combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and check-point blockade for metastatic non-small cell lung cancer patients who have progressed after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.

Conditions

  • METASTATIC NON-SMALL CELL LUNG CANCER

Interventions

DRUG

Intralesional IL-2

High dose IL-2 (HD-IL-2) is a cytokine produced endogenously by activated T cells and is effective in the treatment of a variety of malignancies because it has both immune-modulating and antitumor properties. In an attempt to take advantage of the robust immune activating effects of IL-2 but avoid the toxicity of high dose systemic IL-2 we and others have investigated the use of intralesional IL-2 injections.

DRUG

Nivolumab

Nivolumab is a fully humanized IgG4 PD-1 blocking antibody which has shown promising efficacy as an immune checkpoint inhibitor in lung cancer. Immune checkpoint blockade will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 2 weeks for patients on Nivolumab.

DRUG

Pembrolizumab

PD-1 inhibitor. Immune checkpoint blockade will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 3 weeks for patients on Pembrolizumab.

RADIATION

Radiotherapy

Radiotherapy will be delivered to the treatment lesion during the first week of therapy using an 8 Gy x 3 fractions palliative regimen. Fractions may be delivered on consecutive or every other day but must be completed during week 1 and will not be repeated in future cycles.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Arta Monjazeb, MD · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-11
Primary Completion
2020-01-10
Completion
2020-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03224871 on ClinicalTrials.gov