Spots Global Cancer Trial Database for Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS)
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Trial Identification
Brief Title: Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS)
Official Title: Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With Undifferentiated Pleomorphic Sarcoma (UPS)
Study ID: NCT06113809
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
Contact Details
Name: Mohammed Milhem, MBBS
Affiliation: University of Iowa Hospitals & Clinics
Role: PRINCIPAL_INVESTIGATOR
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