Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761744
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-16
Brief Title:
A Phase II Study of Nivolumab in Patients With Genetic Alterations in DNA Damage Repair and Response Who Progressed After Standard Treatment for Metastatic Solid Cancers
Sponsor:
Korean Cancer Study Group
Organization:
Korean Cancer Study Group
Study Overview
Official Title:
A Phase II Study of Nivolumab in Patients With Genetic Alterations in DNA Damage Repair and Response Who Progressed After Standard Treatment for Metastatic Solid Cancers
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
A Phase II Study of Nivolumab in Patients with Genetic alterations in DNA Damage repair and response Who Progressed after Standard treatment for Metastatic Solid Cancers
Detailed Description:
All the patients will be included in the final analysis with a total of 48 patients to be enrolled
Treatment will occur until disease progression unacceptable toxicity or patient withdrawal
Study treatment consists of nivolumab 3mgkg and will be repeated every 2 weeks
Response evaluation will be performed every 6 weeks - 1 week window period is allowed
Treatment will occur until disease progression unacceptable toxicity or patient withdrawal
Study treatment consists of nivolumab 3mgkg and will be repeated every 2 weeks
Response evaluation will be performed every 6 weeks - 1 week window period is allowed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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