Actively Recruiting
A Study of Pembrolizumab in People With Ultra-Rare Sarcomas
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14
32
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of Pembrolizumab in People With Ultra-Rare Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of one of the following: pleomorphic liposarcoma, PEComa, epithelioid sarcoma, CIC-rearranged sarcoma, or sclerosing epithelioid fibrosarcoma/low grade fibromyxoid sarcoma
- Molecular characterization of tumor recorded if available
- Recurrent or metastatic disease not curable by other means
- Progression after most recent therapy or stopped prior therapy due to toxicity or choice, documented with tumor measurements when available
- Measurable disease per RECIST 1.1, including lesions in previously irradiated areas if progression shown for at least 3 months
- Treated brain metastases allowed if no progression on imaging at least 4 weeks after CNS therapy
- One to three prior lines of therapy permitted
- Recovery to Grade 1 or baseline from prior therapy adverse events, with some exceptions for endocrine-related or neuropathy AEs
- Administration of killed vaccines allowed
- Age 18 years or older
- ECOG Performance Status 0-1 (Karnofsky 70-100)
- Adequate organ function within 14 days before study start, including hematologic, renal, and cardiac function
- For HIV-positive patients: on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4+ count at least 350 cells/mm3
- For HBV patients: viral load undetectable on suppressive therapy if indicated
- For HCV patients: treated and cured or on treatment with undetectable viral load
You will not qualify if you...
- Prior diagnosis of immunodeficiency or use of systemic immunosuppressive therapy exceeding 10 mg prednisone equivalent daily within 14 days before first dose
- Active malignancy other than stable breast or prostate cancer on hormonal therapy or CLL Rai stage 0
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapy
- Prior or current pneumonitis/interstitial lung disease requiring steroids or current pneumonitis
- Not fully recovered from major surgery within 4 weeks or minor procedures within 2 weeks before treatment
- Conditions or therapies interfering with study participation or results as judged by investigator
- Known psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning pregnancy through 120 days after last dose
- Prior allogenic tissue or solid organ transplant
- Documented leptomeningeal disease, even if treated
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks (2 weeks for kinase inhibitors or IV chemo)
- Prior investigational agents or devices within 4 weeks
- Radiotherapy within 2 weeks of study start or radiation toxicities requiring corticosteroids; limited palliative radiotherapy allowed
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other stimulatory/co-inhibitory T-cell receptor agents
- Live or live-attenuated vaccine within 30 days before first dose
- Known bleeding disorders
- Active infection requiring systemic therapy
- History of allergic reaction to study agent or similar compounds
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
6
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
R
Robert Maki, MD, MPH
CONTACT
L
Lauren Banks, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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