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Palbociclib and Pembrolizumab for Sarcoma

This study is testing a combination of two drugs, palbociclib and pembrolizumab, for people with certain types of advanced sarcoma. Palbociclib is given first for two weeks, then pembrolizumab is added. Researchers want to see if palbociclib helps pembrolizumab work better by changing the tumor environment. This study is open to patients aged 12 and older with locally advanced, unresectable, or metastatic sarcoma for which PD-1 inhibitors are approved, such as undifferentiated pleomorphic sarcoma. The main goal is to find out about any side effects and how well the drugs are tolerated. The study is currently unclear on its recruitment status and plans to enroll 8 participants.

Study design
This is a single-arm, open-label study, meaning all participants receive the same treatment and both participants and researchers know which treatment is being given. It plans to include 8 participants.
What's involved
You would receive palbociclib daily for 21 days out of every 28 days, and pembrolizumab intravenously every three weeks. You would have at least two tumor biopsies and disease response will be assessed at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main safety measures (dose limiting toxicities and adverse events) are measured for 4 weeks after starting pembrolizumab. Disease response is assessed at 8 weeks.

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NCT06113809

Palbociclib and Pembrolizumab in Sarcoma

Recruiting
PHASE1Ages 12+InterventionalTreatment
John Rieth
~8 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:PalbociclibPembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5
Measured over The dose limiting toxicity period is 4 weeks after starting the first dose of pembrolizumab

Conditions

Sarcoma

Explore related trials

Alveolar Soft Part SarcomaAngiosarcomaMyxofibrosarcomaPleomorphic LiposarcomaPleomorphic RhabdomyosarcomaSarcomaUndifferentiated Pleomorphic Sarcoma

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • John Rieth, MD · PRINCIPAL_INVESTIGATOR · University of Iowa Hospitals & Clinics

Who to contact

John Rieth, MD
[email protected]
3193561616
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5The 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 sarcomas for which PD-1 inhibitors are approved as defined by the incidence of DLTs