Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT07100704
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab
Sponsor:
National Cancer Center Hospital East
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial Evaluating the Efficacy and Safety of Nivolumab Monotherapy for Incurable Recurrent or Metastatic Olfactory Neuroblastoma.
Status:
RECRUITING
Status Verified Date:
2025-07
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:
Orion
Brief Summary:
This trial evaluates the efficacy and safety of nivolumab monotherapy in patients with recurrent or metastatic olfactory neuroblastoma that is difficult to treat with curative intent. Specifically, nivolumab 240 mg will be administered on Day 1 and Day 15 of each cycle, or nivolumab 480 mg will be administered on Day 1 of each cycle, and this will be continued until disease progression. One cycle is 28 days. The decision on which treatment to administer will be made through consultation between the participant in this trial and their attending physician.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| jRCT1031240654 | OTHER | Ministry of Health, Labour and Welfare | View |