Pembrolizumab In Central Nervous System Metastases

Phase 2 Active not recruiting 101 enrolled Massachusetts General Hospital Merck Sharp & Dohme LLC · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This research study is studying Pembrolizumab as a possible treatment for this diagnosis for metastases in the central nervous system (brain and spinal cord).

Timeline

Start: 2016-10
Primary completion: 2027-06
Completion: 2028-06

Outcome

Met primary endpoint

paper The primary endpoint was met with an intracranial benefit rate of 42.1% (90% confidence interval (CI): 31-54%). PMID 37268724 ↗

paper The study met the primary endpoint, as 12 of 20 (OS3, 0.60; 90% confidence interval, 0.39-0.78) patients were alive at 3 months after enrollment. PMID 32483359 ↗

Publications

Brastianos PK, Kim AE, Giobbie-Hurder A, Lee EQ, Lin NU, Overmoyer B, Wen PY, Nayak L, Cohen JV, Dietrich J, Eichler A, Heist RS, Krop I, Lawrence D, Ligibel J, Tolaney S, Mayer E, Winer E, Bent B, de Sauvage MA, Ijad N, Larson JM, Marion B, Nason S, Murthy N, Ratcliff S, Summers EJ, Mahar M, Shih HA, Oh K, Cahill DP, Gerstner ER, Sullivan RJ. Pembrolizumab in brain metastases of diverse histologies: phase 2 trial results. Nat Med. 2023 Jul;29(7):1728-1737. doi: 10.1038/s41591-023-02392-7. Epub 2023 Jun 2.
Brastianos PK, Lee EQ, Cohen JV, Tolaney SM, Lin NU, Wang N, Chukwueke U, White MD, Nayyar N, Kim A, Alvarez-Breckenridge C, Krop I, Mahar MK, Bertalan MS, Shaw B, Mora JL, Goss N, Subramanian M, Nayak L, Dietrich J, Forst DA, Nahed BV, Batchelor TT, Shih HA, Gerstner ER, Moy B, Lawrence D, Giobbie-Hurder A, Carter SL, Oh K, Cahill DP, Sullivan RJ. Single-arm, open-label phase 2 trial of pembrolizumab in patients with leptomeningeal carcinomatosis. Nat Med. 2020 Aug;26(8):1280-1284. doi: 10.1038/s41591-020-0918-0. Epub 2020 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous