drugset / Trial / NCT04021043

BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers

NCT04021043 ↗

Phase 1/2 Completed 51 enrolled M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) agonistic monoclonal antibody BMS-986156 (BMS-986156) when given together with ipilimumab and nivolumab with or without stereotactic body radiation therapy and to see how well they work in treating patients with lung/chest or liver cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as BMS-986156, ipilimumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving BMS-986156, ipilimumab, and nivolumab with or without stereotactic body radiation therapy will work better in treating patients with lung/chest or liver cancers.

Timeline

Start
2019-08-19
Primary completion
2025-04-14
Completion
2025-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986156 Monoclonal antibody 30 mg Intravenous
Subject BMS-986156 Monoclonal antibody 100 mg Intravenous
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous