Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS)

Phase 1

Recruiting

• Conditions: Undifferentiated Pleomorphic Sarcoma
• Interventions: Drug: Palbociclib; Drug: Pembrolizumab

• Registration Number: NCT06113809
• Lead Sponsor: John Rieth

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 Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-02
• Study Start: 2024-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination of Palbociclib with Pembrolizumab	Palbociclib	Palbociclib given 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.
Combination of Palbociclib with Pembrolizumab	Pembrolizumab	Palbociclib given 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.

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5	The dose limiting toxicity period is 4 weeks after starting the first dose of pembrolizumab	Confirm the safety of the combination of Palbociclib and Pembrolizumab in UPS as defined by the incidence of DLTs

Secondary Outcome Measures

Name	Time	Method
Response rate per RECIST 1.1 criteria	8 weeks following treatment intiation	To assess the response (per RECIST 1.1 criteria) of patients with advanced UPS with the combination of CDK4/6 inhibitor and anti-PD-1 immunotherapy

Trial Locations

Locations (1)

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States