Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03758781
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2018-11-28
Brief Title:
IRX-2 Regimen Combined With Nivolumab in RecurrentMetastatic Solid Tumors
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
The IRX-2 Regimen Combined With Nivolumab in RecurrentMetastatic Solid Tumors A Phase 1b Study to Evaluate the Safety Determine Recommended Phase 2 Dose RP2D and Investigate the Biologic and Clinical Activity
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone
Detailed Description:
The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18 If no dose limiting toxicities DLTs are observed during the first 4 weeks of treatment the enrollment will continue in a dose expansion phase If there is a study treatment related DLT in 1 of 6 patients the same dose will be investigated at the dose expansion cohorts If study treatment related DLT is observed in 2 of 6 patients accrual will be stopped and new dose levels or treatment sequences will be considered
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