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

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

Outcome

Met primary endpoint

paper The primary endpoint of safety was met, with maximum tolerated doses of 800 mg relatlimab for monotherapy and 160 mg relatlimab/240 mg nivolumab for combination therapy. PMID 42432293 ↗

Publications

• Lim M, Ye X, Piotrowski AF, Desai A, Ahluwalia MS, Walbert T, Lesser G, Ellingson BM, Peereboom DM, Fisher JD, Desideri S, Jackson C, Pant A, Jain A, Verma R, Oberlton B, Piyadasa H, Bettegowda C, Engle L, Taube J, Bendall SC, Choi J, Drappatz J, Lieberman FS, Kleinberg LR, Pardoll DM, Nabors LB, Wen PY, Grossman SA. Anti-LAG-3 with or without anti-PD-1 in recurrent glioblastoma: a phase 1 trial. Nat Med. 2026 Jul 10. doi: 10.1038/s41591-026-04475-7. Online ahead of print.

Drugs

Indications