SarcomaPhase 2NCT07089992
A Study of Pembrolizumab in People With Ultra-Rare Sarcomas
A Phase 2 study testing Pembrolizumab in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Dec 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically confirmed diagnosis of one of the following:
- Pleomorphic liposarcoma
- PEComa (perivascular epithelial cell tumor)
- Epithelioid sarcoma
- CIC-rearranged sarcoma
- SEF/LGFMS: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma
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- 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 or stop prior therapy due to toxicity or patient choice. The reason for this progression or other reason for changing therapy 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Robert Maki, MD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725
Robert Maki, MD, PhD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Robert Maki, MD, PhD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Robert Maki, MD, PhD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Robert Maki, MD, PhD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Robert Maki, MD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Robert Maki, MD, PhD, 646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
About this study
Official title: URSa-1: A Minibasket Study of Pembrolizumab in Ultra-Rare Sarcomas
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.
- Conditions
- Sarcoma
- Being tested
- Pembrolizumab
- Keywords
- Pleomorphic liposarcoma, PEComa (perivascular epithelial cell tumor), Epithelioid sarcoma, CIC-rearranged sarcoma, SEF/LGFMS: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma, Ultra-Rare Sarcomas, Pembrolizumab, 25-165
- Medical subject headings
- Sarcoma, Liposarcoma, Perivascular Epithelioid Cell Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Q 6 weeks IV infusion Day 1 of each 6-week cycle, up to 8 doses
| Study group | Role | What they receive |
|---|---|---|
| Pleomorphic liposarcoma | Experimental | Pembrolizumab Q 6 weeks IV infusion Receives: Drug: Pembrolizumab |
| PEComa (perivascular epithelial cell tumor) | Experimental | Pembrolizumab Q 6 weeks IV infusion Receives: Drug: Pembrolizumab |
| Epithelioid sarcoma | Experimental | Pembrolizumab Q 6 weeks IV infusion Receives: Drug: Pembrolizumab |
| CIC-rearranged sarcoma | Experimental | Pembrolizumab Q 6 weeks IV infusion Receives: Drug: Pembrolizumab |
| Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma | Experimental | Pembrolizumab Q 6 weeks IV infusion Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
iRECIST, which is based on RECIST 1.1
Measured: 12 weeks
Secondary outcomes (1)
Toxicity assessment
NCI CTCAE Version 5, Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start4 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Robert Maki, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089992
- Sponsor's protocol ID
- 25-165
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- URSa-1: A Minibasket Study of Pembrolizumab in Ultra-Rare Sarcomas
- ClinicalTrials.gov ID
- NCT07089992
- Acronym / sponsor ID
- 25-165
- Conditions
- Sarcoma
- Keywords
- Pleomorphic liposarcoma, PEComa (perivascular epithelial cell tumor), Epithelioid sarcoma, CIC-rearranged sarcoma, SEF/LGFMS: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma, Ultra-Rare Sarcomas, Pembrolizumab, 25-165
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pleomorphic liposarcoma | Experimental | Drug: PembrolizumabPembrolizumab Q 6 weeks IV infusion |
| PEComa (perivascular epithelial cell tumor) | Experimental | Drug: PembrolizumabPembrolizumab Q 6 weeks IV infusion |
| Epithelioid sarcoma | Experimental | Drug: PembrolizumabPembrolizumab Q 6 weeks IV infusion |
| CIC-rearranged sarcoma | Experimental | Drug: PembrolizumabPembrolizumab Q 6 weeks IV infusion |
| Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma | Experimental | Drug: PembrolizumabPembrolizumab Q 6 weeks IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients must have pathologically confirmed diagnosis of one of the following:
- 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 or stop prior therapy due to toxicity or patient choice. The reason for this progression or other reason for changing therapy must be documented, employing tumor measurements when available.
- Definition of Measurable Disease
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabQ 6 weeks IV infusion Day 1 of each 6-week cycle, up to 8 doses | Drug | CIC-rearranged sarcoma, Epithelioid sarcoma, PEComa (perivascular epithelial cell tumor), Pleomorphic liposarcoma, Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma |
Primary outcome
Response rate
Time frame: 12 weeks
iRECIST, which is based on RECIST 1.1
1 secondary outcome
Toxicity assessment
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Maki, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Maki, MD, MPH (646-888-5059, zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.