Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04562129
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2020-09-18
Brief Title:
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of High Dose Bolus IL2 in Combination With Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma
Detailed Description:
This is a Phase II study of high dose bolus interleukin-2 HD IL2 in combination with low dose ipilimumab followed sequentially by nivolumab in patients with advanced inoperable stage III or stage IV melanoma who have failed prior anti-PD1 immunotherapy
The planned treatment consists of up to 3 courses One cycle is 21 days and one course is 4 cycles HD IL2 will be given during week 1 of the 2 initial cycles or each course Ipilimumab will be given concurrently at the low dose of 1 mgkg on Day 1 of the 2 initial cycles of each course for up to 2 doses total Nivolumab will be given on Day 1 of the 3rd cycle of each course No systemic treatment will be administered during the 4th cycle Response assessment will occur at the end of the 4th cycle Patients without evidence of disease progression RECIST v11 or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses total
The planned treatment consists of up to 3 courses One cycle is 21 days and one course is 4 cycles HD IL2 will be given during week 1 of the 2 initial cycles or each course Ipilimumab will be given concurrently at the low dose of 1 mgkg on Day 1 of the 2 initial cycles of each course for up to 2 doses total Nivolumab will be given on Day 1 of the 3rd cycle of each course No systemic treatment will be administered during the 4th cycle Response assessment will occur at the end of the 4th cycle Patients without evidence of disease progression RECIST v11 or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses total
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIIT19PLK13 | OTHER | Clinigen | None |