Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03311542
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-01-10
First Post:
2017-10-12
Brief Title:
Expanded Access for Pembrolizumab MK-3475
Sponsor:
Center Trials Treatment
Organization:
Center Trials Treatment
Study Overview
Official Title:
Expanded Access for Pembrolizumab MK-3475 to Patients With Melanoma or Glioblastoma Glioma After Failed Standart Therapy at High Mutational Load Which is Confirmed by the Results of Molecular-genetic Analysis of Tumor Tissue
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an expanded access program EAP for patient with Melanoma and Glioblastoma who have progressed after prior Protocol therapy including Bevacizumab Temozolomide TMZ Ipilimumab BRAF and MEK inhibitors The patients whose tumors are EGFR MET or ALK positive should first receive an EFGR or ALK inhibitor respectively prior to treatment with pembrolizumab
Detailed Description:
Pembrolizumab has been approved by the US Food and Drug Administration for the treatment of patients with Glioblastoma and Melanoma The Expanded Access Program EAP for this medicine in the US is closed The EAP will continue outside the US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None