Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03332498
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2017-11-02
Brief Title:
Pembrolizumab in Combination With Ibrutinib for Advanced Refractory Colorectal Cancers
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase III Study of Pembrolizumab in Combination With Ibrutinib for Advanced Refractory Colorectal Cancers
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The purpose of this study is to determine the safety and tolerability describe the dose-limiting toxicities DLTs and determine the maximum tolerated dose MTD or the highest protocol-defined dose level in the absence of establishing an MTD of ibrutinib in combination with pembrolizumab in participants with advanced refractory colorectal cancers
Detailed Description:
On this study one treatment cycle equals 21 days On the first day of each study treatment cycle 200 milligrams of pembrolizumab will be given through an IV intravenously for about thirty minutes In addition participants will begin taking the ibrutinib capsules every day starting on cycle 1 day 1 Participants will have a follow-up visit every 3 weeks on about the first day of each cycle with laboratories drawn to make sure that the study drugs are not causing any side effects In addition participants will have a computed tomography CT scan every 6 to 7 weeks to determine whether your cancer is getting better or worse
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?:
False
Is an FDA AA801 Violation?:
None