Clinical Trial: Pembrolizumab in Patients With Leptomeningeal Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pembrolizumab in Patients With Leptomeningeal Disease

Brief Summary: This is an open-label phase II study of pembrolizumab in patients with advanced solid tumors with leptomeningeal carcinomatosis (LMD). Patients may have received any number of prior therapies for their respective solid tumors, but must not have received prior anti-PD-1 therapy and developed progressive disease. Approximately 18 subjects in this study will receive pembrolizumab at a dose of 200mg intravenously (IV) every 3 weeks (Q3W) for 4 doses. In patients who derive clinical benefit from therapy, pembrolizumab may be continued until documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdrawal of consent, noncompliance with trial treatment or procedure requirements, or for administrative reasons.

Detailed Summary:
Sponsor: Sidney Kimmel Comprehensive Cancer Center

Current Primary Outcome: Number of participants with a response [ Time Frame: at 12 weeks/after 4 cycles of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sidney Kimmel Comprehensive Cancer Center

Dates:
Date Received: January 3, 2017
Date Started: May 1, 2017
Date Completion: May 30, 2022
Last Updated: April 19, 2017
Last Verified: April 2017