Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06113809
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-10-16
Brief Title:
Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma UPS
Sponsor:
Mohammed Milhem
Organization:
University of Iowa
Study Overview
Official Title:
Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With Undifferentiated Pleomorphic Sarcoma UPS
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:
This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib
Detailed Description:
Patients will be given palbociclib for 2 weeks following a pre-treatment ultrasound guided biopsy used to establish immunological baseline of the tumor microenvironment After 2 weeks of palbociclib therapy a second biopsy will be performed to assess the impact of palbociclib on the tumor microenvironment Pembrolizumab will be started the same day as the second biopsy After 2 doses of pembrolizumab a third optional biopsy may be performed if the subject consents At 8 weeks of therapy disease response will be assessed as per standard of care
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