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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

August 11, 2017

Primary Completion Date

January 10, 2020

Study Completion Date

January 10, 2020

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.

Trial Locations (1)

95817

UC Davis Medical Center, Sacramento

All Listed Sponsors
lead

University of California, Davis

OTHER

NCT03224871 - UCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC. | Biotech Hunter | Biotech Hunter