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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT03224871
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • METASTATIC NON-SMALL CELL LUNG CANCER

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intralesional IL-2 — DRUG
    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.
  • Nivolumab — DRUG
    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.
  • Pembrolizumab — DRUG
    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.
  • Radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Aug 11, 2017
Status verified
Apr 2020
Primary completion
Jan 10, 2020
Completion
Jan 10, 2020

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Intralesional IL-2, Radiotherapy will be given to all patients. Immune checkpoint blockade with Nivolumab will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 2 weeks.
  • Experimental: Pembrolizumab
    Intralesional IL-2, Radiotherapy will be given to all patients. Immune checkpoint blockade with Pembrolizumab will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 3 weeks.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: Beginning of treatment to up to 12 months after beginning of treatment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817-

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By research site
UC Davis Medical Center· Sacramento, CA

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