Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556563
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
EF-41KEYNOTE D58 Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Study of Optune TTFields 200 kHz Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma EF-41KEYNOTE D58
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EF-41
Brief Summary:
This is a multicenter two-arm randomized double-blind placebo-controlled study of Optune Tumor Treating Fields at 200 kHz together with maintenance Temozolomide TMZ chemotherapy agent and pembrolizumab compared to Optune together with maintenance TMZ and placebo in newly diagnosed Glioblastoma GBM patients The primary objective of the study is to evaluate the Overall Survival OS
Detailed Description:
None
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