This phase 1/2 study will investigate the safety of a new drug, BMS-986156, combined with ipilimumab (Yervoy), nivolumab (Opdivo) and radiotherapy in advanced lung cancer (LC).
The main outcomes will be the rate of dose-limiting side effects and response to treatment. This trial is recruiting in Texas, US.
Treatment options for advanced lung cancer (LC) are limited. Chemotherapy (CT) and radiotherapy (RT) can improve survival for short periods of time. Immune checkpoint inhibitors (ICIs) are a new treatment for advanced cancer. ICIs block the mechanism that tumor cells use to grow undetected by the immune system.Ipilimumab and nivolumab are ICIs. Studies suggest that combining ICIs with RT can improve survival in advanced LC. BMS-986156 is a glucocorticoid-induced tumor necrosis factor receptor (GITR) agonist. It is a monoclonal antibody that binds to GITR. This stimulates the immune system to recognize tumor cells and attack the tumor.
This study will investigate the safety of BMS-986156, combined with ipilimumab, nivolumab, and RT in advanced LC. The main outcomes will be the rate of side effects and response to treatment.
Who are they looking for?
This study will recruit 60 patients with advanced cancer including LC. Participants must have acceptable liver, kidney and blood results. Stable secondary brain tumors may acceptable. Women of childbearing potential must use highly effective contraception during treatment.Men taking part in the trial must use a condom during sexual intercourse. This must continue for up to 160 (women) and 220 (men) days.
Patients cannot part in the trial if they have an autoimmune disease. Uncontrolled heart conditions, active infection and any illness that might compromise the trial are excluded. Pregnant women are not eligible for this trial. Previous treatment with immuno-oncological drugs is also excluded.
How will it work
There are 3 treatment regimens. All patients will be treated with BMS986156. Patients will also be treated with ipilimumab, nivolumab or both. 2 groups will undergo stereotactic body RT (SBRT). Treatment cycles will last 21 days. 4 treatment cycles will be performed. The groups undergoing SBRT will do so on Day 29-32 or Day 29-40 after cycle 2. Cycle 5 will begin with nivolumab treatment. This will be administered for up to 26 cycles (every 4 weeks).
The main outcomes will be the rate of side effects and response to treatment for up to 1 year.