Pembrolizumab in Patients With Leptomeningeal Disease

Phase 2 Terminated 13 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label phase II study of pembrolizumab in patients with advanced solid tumors with leptomeningeal carcinomatosis (LMD). Approximately 18 subjects in this study will receive pembrolizumab at a dose of 200mg intravenously (IV) every 3 weeks (Q3W) for 4 doses.

Timeline

Start: 2017-04-12
Primary completion: 2019-12-14
Completion: 2019-12-14

Outcome

Outcome not reported

Stopped (Enrollment): “Low Accrual”

Publications

Naidoo J, Schreck KC, Fu W, Hu C, Carvajal-Gonzalez A, Connolly RM, Santa-Maria CA, Lipson EJ, Holdhoff M, Forde PM, Douville C, Riemer J, Barnes A, Redmond KJ, Kleinberg L, Page B, Aygun N, Kinzler KW, Papadopoulos N, Bettegowda C, Venkatesan A, Brahmer JR, Grossman SA. Pembrolizumab for patients with leptomeningeal metastasis from solid tumors: efficacy, safety, and cerebrospinal fluid biomarkers. J Immunother Cancer. 2021 Aug;9(8):e002473. doi: 10.1136/jitc-2021-002473.

Drugs

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