Phase II study of ipilimumab and nivolumab in leptomeningeal carcinomatosis

Priscilla K. Brastianos (), Matthew R. Strickland, Eudocia Quant Lee, Nancy Wang, Justine V. Cohen, Ugonma Chukwueke, Deborah Anne Forst, April Eichler, Beth Overmoyer, Nancy U. Lin, Wendy Y. Chen, Aditya Bardia, Dejan Juric, Ibiayi Dagogo-Jack, Michael D. White, Jorg Dietrich, Naema Nayyar, Albert E. Kim, Christopher Alvarez-Breckenridge, Maura Mahar, Joana L. Mora, Brian V. Nahed, Pamela S. Jones, Helen A. Shih, Elizabeth R. Gerstner, Anita Giobbie-Hurder, Scott L. Carter, Kevin Oh, Daniel P. Cahill and Ryan J. Sullivan
Additional contact information
Priscilla K. Brastianos: Massachusetts General Hospital
Matthew R. Strickland: Massachusetts General Hospital
Eudocia Quant Lee: Dana-Farber Cancer Institute
Nancy Wang: Massachusetts General Hospital
Justine V. Cohen: Massachusetts General Hospital
Ugonma Chukwueke: Dana-Farber Cancer Institute
Deborah Anne Forst: Massachusetts General Hospital
April Eichler: Massachusetts General Hospital
Beth Overmoyer: Dana-Farber Cancer Institute
Nancy U. Lin: Dana-Farber Cancer Institute
Wendy Y. Chen: Dana-Farber Cancer Institute
Aditya Bardia: Massachusetts General Hospital
Dejan Juric: Massachusetts General Hospital
Ibiayi Dagogo-Jack: Massachusetts General Hospital
Michael D. White: Massachusetts General Hospital
Jorg Dietrich: Massachusetts General Hospital
Naema Nayyar: Massachusetts General Hospital
Albert E. Kim: Massachusetts General Hospital
Christopher Alvarez-Breckenridge: Massachusetts General Hospital
Maura Mahar: Massachusetts General Hospital
Joana L. Mora: Massachusetts General Hospital
Brian V. Nahed: Massachusetts General Hospital
Pamela S. Jones: Massachusetts General Hospital
Helen A. Shih: Massachusetts General Hospital
Elizabeth R. Gerstner: Massachusetts General Hospital
Anita Giobbie-Hurder: Dana-Farber Cancer Institute
Scott L. Carter: Dana-Farber Cancer Institute
Kevin Oh: Massachusetts General Hospital
Daniel P. Cahill: Massachusetts General Hospital
Ryan J. Sullivan: Massachusetts General Hospital

Nature Communications, 2021, vol. 12, issue 1, 1-7

Abstract: Abstract Leptomeningeal disease (LMD) is a common complication from solid tumor malignancies with a poor prognosis and limited treatment options. We present a single arm Phase II study of 18 patients with LMD receiving combined ipilimumab and nivolumab until progression or unacceptable toxicity (NCT02939300). The primary end point is overall survival at 3 months (OS3). Secondary end points include toxicity, cumulative time-to-progression at 3 months, and progression-free survival. A Simon two-stage design is used to compare a null hypothesis OS3 of 18% against an alternative of 44%. Median follow up based on patients still alive is 8.0 months (range: 0.5 to 15.9 months). The study has met its primary endpoint as 8 of 18 (OS3 0.44; 90% CI: 0.24 to 0.66) patients are alive at three months. One third of patients have experienced one (or more) grade-3 or higher adverse events. Two patients have discontinued protocol treatment due to unacceptable toxicity (hepatitis and colitis, respectively). The most frequent adverse events include fatigue (N = 7), nausea (N = 6), fever (N = 6), anorexia (N = 6) and rash (N = 6). Combined ipilimumab and nivolumab has an acceptable safety profile and demonstrates promising activity in LMD patients. Larger, multicenter clinical trials are needed to validate these results.

Date: 2021
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DOI: 10.1038/s41467-021-25859-y

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