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Clinical Trial Summary

This is a single-arm open-label window of opportunity clinical study assessing the impact of pre- treatment with palbociclib


Clinical Trial Description

This is a single-arm open-label window of opportunity clinical study assessing the impact of pre- treatment with palbociclib. Patients with be given palbociclib for 2 weeks following a pre-treatment ultrasound guided biopsy used to establish an immunological baseline of the tumor microenvironment. After the conclusion of palbociclib therapy, a post-treatment 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 could be performed. At 8 weeks of therapy disease response will be assessed as per standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06113809
Study type Interventional
Source University of Iowa
Contact Mohammed Milhem, MBBS
Phone (319) 356-2324
Email mohammed-milhem@uiowa.edu
Status Recruiting
Phase Phase 1
Start date February 1, 2024
Completion date July 2028

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