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New combo therapy aims to shrink sarcomas

NCT ID NCT06113809

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

12 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.