Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02617589
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2015-11-26
Brief Title:
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide Each Given With Radiation Therapy 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 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT Tumor O-6-methylguanine DNA Methyltransferase Glioblastoma CheckMate 498 CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03126643
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
CheckMate 498
Brief Summary:
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated the MGMT gene is not altered by a chemical change Patients will receive Nivolumab every two weeks in addition to radiation therapy and then every four weeks They will be compared to patients receiving standard therapy with temozolomide in addition to 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 |
|---|---|---|---|
| 2015-003739-37 | EUDRACT_NUMBER | None | None |