Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02667587
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2016-01-26
Brief Title:
An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo for Newly Diagnosed Patients With Glioblastoma GBM a Malignant Brain Cancer
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated Tumor O6-methylguanine DNA Methyltransferase Glioblastoma
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT02475382
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
CheckMate548
Brief Summary:
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated the MGMT gene is altered by a chemical change Patients will receive temozolomide plus radiation therapy They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-004722-34 | EUDRACT_NUMBER | None | None |