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RECRUITING
NCT06113809
PHASE1

Palbociclib and Pembrolizumab in Sarcoma

Sponsor: John Rieth

View on ClinicalTrials.gov

Summary

This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib in patients with soft tissue sarcomas for which PD-1 inhibitors are approved (includes undifferentiated pleomorphic sarcoma, myxofibrosarcoma, angiosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, or alveolar soft part sarcoma).

Official title: Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With Sarcoma

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2024-02-01

Completion Date

2028-07

Last Updated

2025-06-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Palbociclib

Palbociclib is a CDK4/6 inhibitor. Palbociclib, 125 mg, (pediatric dose 75mg/m2 up to 125mg) daily for 21 days out of every 28 days, PO (orally) starting 14 days prior to Pembrolizumab

DRUG

Pembrolizumab

Pembrolizumab is a PD-1 blocking antibody. Given 14 days following Palbociclib: Pembrolizumab, 200 mg, once every three weeks, intravenously (IV)

Locations (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States