Using palbociclib and pembrolizumab for treating undifferentiated pleomorphic sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effects of palbociclib, a CDK4/6 inhibitor, on the tumor microenvironment in patients with undifferentiated pleomorphic sarcoma (UPS). Participants will receive palbociclib for two weeks following a biopsy to establish a baseline, after which a second biopsy will assess changes in the tumor environment. Pembrolizumab, an immune checkpoint inhibitor, will be administered concurrently with the second biopsy, and disease response will be evaluated after eight weeks of treatment. This single-arm, open-label design aims to gather insights into the combined therapeutic effects of these agents.

Why it matters

Who can join: the full rules

Inclusion Criteria

A potential subject must meet all the following inclusion criteria to be eligible to participate in the study:

* Male or female patients aged \> or = 12 years old
* ECOG Performance Status of \< or = 2
* Any patient with the diagnosis of locally advanced, unresectable or metastatic sarcoma for which PD-1 inhibitors are approved (undifferentiated pleomorphic sarcoma, myxofibrosarcoma, angiosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, alveolar soft part sarcoma) who have progressed on at least 1 prior line of therapy. Prior immunotherapy treatment is allowed, including prior treatment with a PD-1 inhibitor.
* Patients with no known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing treatment for dexamethasone (as ascertained by clinical examination and brain imaging) during the screening period. Stable dose of anticonvulsants is allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
* Ability to understand and the willingness to sign a written informed consent or assent in case of patients \< 18 years old.

Exclusion Criteria

A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study:

* Lab values in the below ranges:
* Neutrophil count \< 1000/mm3
* Platelet count \< 100,000/mm3L
* Hemoglobin \< 9 g/dL (transfusion to meet eligibility allowed)
* AST/SGOT and ALT/SGPT \> 3.0x upper limit of normal (ULN) without disease involvement or \> 5.0x ULN if the transaminase elevation is due to disease involvement
* Alkaline phosphatase \> 5.0x ULN without known bony metastases
* Serum bilirubin \> 1.5x ULN
* Serum creatinine \> 1.5x ULN or 24-hour creatinine clearance \< 30 mL/min per Cockroft- Gault equation
* Total serum calcium \< lower limit of normal (LLN) or if calcium is below LLN the corrected calcium for serum albumin is \> LLN
* Serum potassium \< 3.0
* Serum sodium \< 130
* Serum albumin \< 2.5 g/dL
* History of myocardial infarction. unstable angina, stroke or transient ischemic attack within 6 months prior to Day 1
* History or drug induced pneumonitis (both pembrolizumab and palbociclib can cause pneumonitis)
* Subjects requiring hemodialysis
* Patients with severe hepatic impairment (Childs-Pugh Class C).
* Other concurrent severe and/or uncontrolled medical conditions in the opinion of the investigator which will preclude participation
* Pregnancy (positive pregnancy test) or lactation
* Concomitant use of any other anti-cancer therapy or radiation therapy of the target lesion. Palliative radiation therapy is permitted to non-target lesions.
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent

Where it's running

• University of Iowa Hospitals & Clinics
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: John Rieth, MD — University of Iowa Hospitals & Clinics
• Study coordinator: John Rieth, MD
• Email: john-rieth@uiowa.edu
• Phone: 3193561616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.