Actively Recruiting

Phase 1
Age: 12Years +
All Genders
NCT06113809

Palbociclib and Pembrolizumab in Sarcoma

Led by John Rieth · Updated on 2025-06-03

8

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Palbociclib and Pembrolizumab in Sarcoma

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 12 years or older
  • ECOG Performance Status of 2 or lower
  • Diagnosis of locally advanced, unresectable, or metastatic sarcoma approved for PD-1 inhibitors (including undifferentiated pleomorphic sarcoma, myxofibrosarcoma, angiosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, alveolar soft part sarcoma)
  • Progression after at least one prior line of therapy; prior immunotherapy including PD-1 inhibitors allowed
  • No known central nervous system disease except treated brain metastases with no progression or hemorrhage and stable anticonvulsant dose
  • Ability to understand and willingness to sign informed consent or assent if under 18 years old
Not Eligible

You will not qualify if you...

  • Neutrophil count less than 1000/mm3
  • Platelet count less than 100,000/mm3
  • Hemoglobin less than 9 g/dL (transfusion allowed to meet eligibility)
  • AST/SGOT and ALT/SGPT greater than 3 times upper limit of normal (ULN) without disease involvement or greater than 5 times ULN if related to disease
  • Alkaline phosphatase greater than 5 times ULN without known bone metastases
  • Serum bilirubin greater than 1.5 times ULN
  • Serum creatinine greater than 1.5 times ULN or creatinine clearance below 30 mL/min
  • Total serum calcium below lower limit of normal or corrected calcium above normal if uncorrected is low
  • Serum potassium below 3.0
  • Serum sodium below 130
  • Serum albumin below 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
  • Requirement for hemodialysis
  • Severe hepatic impairment (Child-Pugh Class C)
  • Other severe or uncontrolled medical conditions preventing participation
  • Pregnancy or lactation
  • Concurrent anti-cancer therapy or radiation to target lesion (palliative radiation to non-target lesions allowed)
  • Significant history of non-compliance or inability to provide reliable informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

J

John Rieth, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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