Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-31 @ 8:54 PM
Study NCT ID:
NCT06889493
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
Sponsor:
Peter Hosein, MD
Organization:
Study Overview
Official Title:
A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas or Well-Differentiated High-Grade (Grade 3) Neuroendocrine Tumors
Status:
RECRUITING
Status Verified Date:
2025-12
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:
None
Brief Summary:
The purpose of this study is to determine:
1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.
1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.
3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: