New combo therapy aims to shrink sarcomas
NCT ID NCT06113809
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether giving a targeted drug (palbociclib) before immunotherapy (pembrolizumab) is safe and can help shrink tumors in people with certain soft tissue sarcomas. About 8 participants will receive the combination. The main goal is to check for side effects and find the right dose.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Iowa Hospitals & Clinics
RECRUITINGIowa City, Iowa, 52242, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?