drugset / Trial / NCT02658981

Anti-LAG-3 Alone & in Combination w/ Nivolumab Treating Patients w/ Recurrent GBM (Anti-CD137 Arm Closed 10/16/18)

NCT02658981

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies the safety and best dose of anti-LAG-3 (anti-LAG-3 monoclonal antibody BMS-986016) or urelumab alone and in combination with nivolumab in treating patients with glioblastoma that has returned (recurrent). Anti-LAG-3 monoclonal antibody BMS-986016, urelumab, and nivolumab are antibodies (a type of protein) that may stimulate the cells in the immune system to attack tumor cells. It is not yet known whether anti-LAG-3 monoclonal antibody BMS-986016 or urelumab alone or in combination with nivolumab may kill more tumor cells. (The Anti-CD137 antibody (BMS-663513 - urelumab) treatment arm closed by BMS on 10/16/18 due to closure of BMS Urelumab development program. Subjects currently on treatment may continue.)

Timeline

Start
2016-08-24
Primary completion
2022-04-30
Completion
2023-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Relatlimab Monoclonal antibody 160 mg Intravenous
Subject Relatlimab Monoclonal antibody 800 mg Intravenous
Subject Urelumab Monoclonal antibody Intravenous

Indications