Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02989714
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2016-12-08
Brief Title:
Phase IbII Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor Nivolumab In Metastatic Clear Cell Renal Cell Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase IbII Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor Nivolumab In Metastatic Clear Cell Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2021-06
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:
This will be a single arm multi-site phase IbII clinical trial of standard doses of High Dose Interleukin-2 HD IL2 600000 IUkgdose intravenously during two 5-day cycles 9 days apart in IL-2 eligible clear cell metastatic RCC Renal Cell Carcinoma subjects in combination with Nivolumab
Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate complete response rate and improved survival outcomes compared to either of the individual therapies
Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate complete response rate and improved survival outcomes compared to either of the individual therapies
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 |
|---|---|---|---|
| HUM00120502 | OTHER | University of Michigan | None |