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New combo therapy shows promise for rare cancer

NCT ID NCT04438824

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 2 times

Summary

This study tests whether combining two drugs, palbociclib and INCMGA00012, is safe and effective for people with advanced liposarcoma, a rare cancer of fat cells. About 42 participants with tumors that cannot be removed by surgery or have spread will receive the combination. The goal is to find the best dose and see if tumors shrink.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

42 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Jun 2027

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

18 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 diagnosis of metastatic or unresectable WD/DD liposarcoma. DD liposarcoma must be present. Unresectable is defined as if the primary tumor a) cannot be safely removed surgically or b) would benefit from systemic therapy prior to a surgical approach * Measurable disease by RECIST 1.1 a. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment * Age ≥ 18 years * ECOG performance status 0 or 1 * Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal): 1. Absolute neutrophil count ≥ 1.5 x 109/L 2. Hemoglobin ≥ 8.0 g/dL 3. WBC ≥ 3.0 x 109/L 4. Platelets ≥ 100 x 109/L 5. ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN) 6. AST (SGOT) /ALT (SGPT) ≤ 3 x institutional ULN 7. Creatinine Clearance \> 30 mL/min (calculated by Cockcroft-Gault method) * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) during the trial period through at least 120 days after the last dose of study treatment. * Ability to understand and the willingness to sign a written informed consent document. * Ability to swallow tablets or capsules * Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible Exclusion Criteria: * Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline. * Patients receiving any other investigational agents. * Patients who have received prior treatment with a selective CDK4 inhibitor or an anti-PD-1/PD-L1 agent * Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness/social situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy 1. Patients with a CD4+ count of \> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion 2. Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded * Pregnant women and women who are breast-feeding. * History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment. a. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease * Prolonged QTcF \> 450 ms for men and \> 470 ms for women at Screening. * Patients who have received a live vaccine within 30 days of the start date of the planned study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed * Radiation therapy within 2 weeks prior to study Day 1 * Prior organ transplantation including allogenic stem-cell transplantation * Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3) * Patients who require concomitant use of medications that strongly induce or inhibit CYP3A (per section 15.0)

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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.

Contacts and locations

Locations

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

More trials for these conditions

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