Ignite Creation Date:
2024-05-06 @ 9:22 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02964078
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2016-11-11
Brief Title:
Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Coordinated High Dose Interleukin-2 Aldesleukin Proleukin and Pembrolizumab Anti-PD1 Keytruda for Therapy of Metastatic Kidney Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab
Interleukin-2 IL-2 is also called aldesleukin or Proleukin
Pembrolizumab is also called Keytruda or anti-PD-1 antibody
Interleukin-2 IL-2 is also called aldesleukin or Proleukin
Pembrolizumab is also called Keytruda or anti-PD-1 antibody
Detailed Description:
The treatment is organized into blocks of 9 weeks with pembrolizumab treatment planned for weeks 1 4 and 7 On the second and third blocks interleukin-2 is added for 5 doses at a time one dose every 8 hours on a weekly schedule on the two weeks after the week 1 and the week 4 pembrolizumab doses
There is no dose escalation portion The dose and schedule of IL-2 is fixed 600000 IUkgdose with a cap of 66 mIUdose Doses may be omitted for safety The dose of pembrolizumab is fixed flat dose 200 mgdose
There is no dose escalation portion The dose and schedule of IL-2 is fixed 600000 IUkgdose with a cap of 66 mIUdose Doses may be omitted for safety The dose of pembrolizumab is fixed flat dose 200 mgdose
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 |
|---|---|---|---|
| MISP 52587 | OTHER | None | None |
| IIT15PLK02 | OTHER | Prometheus Laboratories | None |