A Study of Pembrolizumab in People With Ultra-Rare Sarcomas

NCT07089992 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-165
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief 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. 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

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

Outcome Measures

Primary Outcomes (1)

• Response rate

  iRECIST, which is based on RECIST 1.1

  12 weeks

Secondary Outcomes (1)

• Toxicity assessment

  2 years

Study Arms (5)

Pleomorphic liposarcoma

EXPERIMENTAL

Pembrolizumab Q 6 weeks IV infusion

Drug: Pembrolizumab

PEComa (perivascular epithelial cell tumor)

EXPERIMENTAL

Pembrolizumab Q 6 weeks IV infusion

Drug: Pembrolizumab

Epithelioid sarcoma

EXPERIMENTAL

Pembrolizumab Q 6 weeks IV infusion

Drug: Pembrolizumab

CIC-rearranged sarcoma

EXPERIMENTAL

Pembrolizumab Q 6 weeks IV infusion

Drug: Pembrolizumab

Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma

EXPERIMENTAL

Pembrolizumab Q 6 weeks IV infusion

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

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

CIC-rearranged sarcoma; Epithelioid sarcoma; PEComa (perivascular epithelial cell tumor); Pleomorphic liposarcoma; Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma; Liposarcoma; Perivascular Epithelioid Cell Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue

Study Officials

• Robert Maki, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Maki, MD, MPH

CONTACT

646-888-5059; zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org

Lauren Banks, MD, PhD

CONTACT

646-888-6784; zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (6)