Palbociclib and pembrolizumab tested in people with sarcoma
Tests palbociclib before pembrolizumab in people with certain soft tissue sarcomas.
Plain-language title generated from the registry record
Registry title: Palbociclib and Pembrolizumab in Sarcoma
Key facts
- Where
- Iowa City, United StatesSee the site
- Phase
- Phase 1
Where in United States
- University of Iowa Hospitals & ClinicsIowa City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- John Rieth
- Trial code
- NCT06113809
- Record updated
- 22 May 2026
- Original description
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).Read full original descriptionShow less
Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With Sarcoma
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).
Inclusion: 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: History of myocardial infarction. unstable angina, stroke or transient ischemic attack within 6 months prior to Day 1; Other concurrent severe and/or uncontrolled medical conditions in the opinion of the investigator which will preclude participation; Concomitant use of any other anti-cancer therapy or radiation therapy of the target lesion. Palliative radiation therapy is permitted to non-target lesions; History or drug induced pneumonitis (both pembrolizumab and palbociclib can cause pneumonitis); Patients with severe hepatic impairment (Childs-Pugh Class C); Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent; 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; A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study:; Subjects requiring hemodialysis; Pregnancy (positive pregnancy test) or lactation.