Pembrolizumab in Patients With Leptomeningeal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03091478|
Recruitment Status : Terminated (Low Accrual)
First Posted : March 27, 2017
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Patients With Leptomeningeal Disease||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab in Patients With Leptomeningeal Disease|
|Actual Study Start Date :||April 12, 2017|
|Actual Primary Completion Date :||December 14, 2019|
|Actual Study Completion Date :||December 14, 2019|
Experimental: Pembrolizumab 200 mg
Pembrolizumab 200 mg every 3 weeks
200mg every 3 weeks
Other Name: Keytruda
- Number of Participants With a Response [ Time Frame: At 12 weeks ]Eligible patients who receive at least one dose of pembrolizumab.
- CNS Progression-free Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab [ Time Frame: From the date of study entry until date of death from any cause, assessed up to 24 months ]To determine whether pembrolizumab administered in patients with Leptomeningeal disease (LMD) from solid tumors improves central nervous system (CNS) progression-free survival (PFS).
- Overall Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab [ Time Frame: From the date of study entry until date of death from any cause, assessed up to 24 months ]To determine whether pembrolizumab administered in patients with LMD from solid tumors improves overall survival (OS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091478
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Jarushka Naidoo, MD||Johns Hopkins School of Medicine|