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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study of Pembrolizumab in People With Ultra-Rare Sarcomas

URSa-1: A Minibasket Study of Pembrolizumab in Ultra-Rare Sarcomas

A Study of Pembrolizumab in People With Ultra-Rare Sarcomas (NCT07089992) is a Phase 2 interventional studying Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of the study is to find out if pembrolizumab is a useful treatment that causes few or mild side effects in people with ultra-rare sarcoma. The researchers will also study how the immune system responds to the study treatment. Pembrolizumab is a type of drug called a PD-1 inhibitor. It is designed to block a protein called programmed cell death protein 1 (PD-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Sarcoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion: - Patients must have pathologically confirmed diagnosis of one of the following: 1. Pleomorphic liposarcoma 2. PEComa (perivascular epithelial cell tumor) 3. Epithelioid sarcoma 4. CIC-rearranged sarcoma 5. SEF/LGFMS: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma - Molecular characterization of the tumor, if available, will be recorded. If no such molecular data are available, note as such. - Patient should have recurrent or metastatic disease not judged to be curable with other means - Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy. The reason for this progression must be documented, employing tumor measurements when available. - Definition of Measurable Disease - Measurable disease as per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions for a minimum of 3 months after completion of such therapy - Patients with treated brain metastases are eligible if follow up brain imaging after CNS-directed therapy shows no evidence of progression at least 4 weeks after the completion of therapy as shown by follow up imaging before study screening - One to 3 prior lines of therapy are permitted (including neoadjuvant/adjuvant or metastatic/recurrent disease) - Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. Patients with alopecia and other toxicities considered clinically nonsignificant and/or stable on supportive therapy, as determined by the investigator, are also permitted on study. - Administration of killed vaccines is allowed - Age ≥ 18 years of age. - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1 (Karnofsky 70-100) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion: * Patients must have pathologically confirmed diagnosis of one of the following: 1. Pleomorphic liposarcoma 2. PEComa (perivascular epithelial cell tumor) 3. Epithelioid sarcoma 4. CIC-rearranged sarcoma 5. SEF/LGFMS: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma * Molecular characterization of the tumor, if available, will be recorded. If no such molecular data are available, note as such. * Patient should have recurrent or metastatic disease not judged to be curable with other means * Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy. The reason for this progression must be documented, employing tumor measurements when available. * Definition of Measurable Disease * Measurable disease as per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions for a minimum of 3 months after completion of such therapy * Patients with treated brain metastases are eligible if follow up brain imaging after CNS-directed therapy shows no evidence of progression at least 4 weeks after the completion of therapy as shown by follow up imaging before study screening * One to 3 prior lines of therapy are permitted (including neoadjuvant/adjuvant or metastatic/recurrent disease) * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. Patients with alopecia and other toxicities considered clinically nonsignificant and/or stable on supportive therapy, as determined by the investigator, are also permitted on study. * Administration of killed vaccines is allowed * Age ≥ 18 years of age. * ECOG Performance Status 0-1 (Karnofsky 70-100) * Required organ function (specimens to be collected within 14 days of the start of the study intervention) * Adequate hematologic function, defined as: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 9 g/dl * Adequate renal function defined, as: * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert disease who have bilirubin level ≤ 3 x ULN may be enrolled) * AST and ALT ≤3 x institutional ULN * Adequate cardiac function, defined as: class II or better New York Heart Association (NYHA) Functional Classification. * For patients with known HIV, HBV, and/or HCV infection \[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection\]: * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4+ T cell count of at least 350 cell/mm3 are eligible for this trial. * HIV-infected patients with a history of either Kaposi sarcoma or Castleman disease are excluded from this study * HIV-infected patients must not have had an AIDS defining opportunistic infection within the past 12 months * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Exclusion: * No prior diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug. * No other active malignancy, other than breast or prostate cancer stable for at least 6 months on hormonal therapy, or CLL Rai stage 0. Cancer in situ will not be considered an active malignancy. * No active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) * No prior (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Must have adequately recovered from major surgery (at least 4 weeks), without ongoing surgical complications. Patients should have had any minor procedures (e.g. port placement, percutaneous nephrostomy) at least 2 weeks prior to the first day of treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's ability to cooperate with the requirements of the study participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. * No known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Not pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. * No prior allogenic tissue/solid organ transplant. * Patients with documented leptomeningeal disease are excluded from study, even if treated. * No prior systemic anti-cancer therapy including investigational agents within 4 weeks, 2 weeks for kinase inhibitors or intravenous chemotherapy, prior to starting therapy on study * No investigational agent(s) administration or use of investigational device within 4 weeks prior to study intervention administration. * No prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention. * No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). * No live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. * No known bleeding diathesis (e.g. hemophilia, DIC) * No active infection requiring systemic therapy * No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).

Treatments Being Tested

DRUG

Pembrolizumab

Q 6 weeks IV infusion Day 1 of each 6-week cycle, up to 8 doses

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07089992), the sponsor (Memorial Sloan Kettering Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07089992 clinical trial studying?

The purpose of the study is to find out if pembrolizumab is a useful treatment that causes few or mild side effects in people with ultra-rare sarcoma. The researchers will also study how the immune system responds to the study treatment. Pembrolizumab is a type of drug called a PD-1 inhibitor. It is designed to block a protein called programmed cell death protein 1 (PD-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07089992?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07089992?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07089992. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07089992. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.