This phase 1/2 trial will investigate BMS-986253, an experimental drug, in combination with nivolumab (Opdivo) to treat advanced cancer.
The main outcomes will be the occurrence of side effects and tumor response.
Advanced cancers have limited treatment options. New drugs are in development to improve patient prognosis. These include immunotherapy drugs. These drugs target the immune system. Cancer cells can trick the immune system and grow without being detected. Immunotherapies act in different ways to facilitate the immune system. Immune checkpoint inhibitors (ICIs) target proteins that cancer cells hijack to go undetected. Nivolumab is an ICI. It is an FDA-approved drug. Another target is interleukin-8 (Il-8). Inhibiting this molecule can slow tumor progression. BMS-986253 is an Il-8 inhibitor. It is an experimental drug.
This trial will investigate BMS-986253 in combination with nivolumab to treat advanced cancer. The main outcomes will be the occurrence of side effects and tumor response.
Who are they looking for?
This trial will recruit 280 participants with advanced cancer. Patients must have a solid tumor. Patients must be willing to have a biopsy of the tumor.
Patients cannot take part in the trial if they have brain metastases (tumors). Other exclusion criteria are active autoimmune diseases, corticosteroid treatment, active infections or treatment with anti-cancer drugs within the 4 previous weeks.
How will it work
There are 2 phases to the trial. Patients will be assigned to a dose of BMS-986253 and nivolumab. When a safe and effective dose is determined the second phase begins. Patients in this phase with be administered BMS-986253 and nivolumab. If well tolerated, patients will be treated for up to 5 years.
The main outcome will be the occurrence of side effects and tumor response.