RecruitingPhase 1NCT06113809

Palbociclib and Pembrolizumab in Sarcoma

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


Sponsor

John Rieth

Enrollment

8 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two cancer drugs — palbociclib (a targeted therapy) and pembrolizumab (an immunotherapy) — in patients with sarcoma, a type of cancer that forms in bones and soft tissues. These cancers can be hard to treat once they spread, and this trial explores whether this drug combination can improve outcomes. **You may be eligible if:** - You are 12 years or older - You have been diagnosed with locally advanced, unresectable, or metastatic sarcoma of a type approved for PD-1 inhibitor treatment - Your overall health status is reasonably good (ECOG 0-2) - Your cancer has progressed after at least one prior line of treatment **You may NOT be eligible if:** - Your cancer is a specific sarcoma subtype excluded from the study - You have severe organ dysfunction or certain other serious health conditions - You have previously received palbociclib or certain immunotherapy drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

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

DRUGPembrolizumab

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

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NCT06113809


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