Actively Recruiting
A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
30
Participants Needed
7
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether giving the study drug pembrolizumab in combination with the chemotherapy drugs melphalan and dactinomycin, delivered directly to the affected arm or leg using a technique called isolated limb infusion (ILI), is a safe treatment that can delay the time before your disease gets worse (progresses).
CONDITIONS
Official Title
A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older at the time of consent
- Willing and able to provide written informed consent or assent
- Willing to follow the treatment protocol
- Histologically confirmed metastatic or locally advanced sarcoma
- Eligible for pembrolizumab treatment
- Eligible for isolated limb infusion (ILI) as determined by the treating physician
- Have had at least one prior systemic therapy or declined standard systemic treatment
- Have measurable disease by RECIST 1.1 criteria or clinical measurement for superficial lesions
- Adequate performance status (ECOG 0-2 or Karnofsky score 60% or higher)
- Adequate organ function within 3 weeks before treatment including specified blood counts, liver and kidney function, and coagulation parameters
- Negative pregnancy test for females of childbearing potential before starting treatment
You will not qualify if you...
- Presence of another active cancer requiring treatment
- Ineligible for ILI due to physical conditions like coronary artery disease preventing anesthesia
- History of allergic reaction to pembrolizumab or its components
- Uncontrolled illnesses including active infections or symptomatic heart failure in past 6 months
- Active brain metastases or sarcomatous meningitis; stable treated brain metastases allowed under conditions
- Significant immunosuppression or use of systemic immunosuppressive therapy above specified doses
- Active infections with HIV (if CD4 count <500), hepatitis B or C, or active tuberculosis
- History of symptomatic or active autoimmune disease requiring systemic treatment in past 2 years
- Pregnancy, breastfeeding, or plans to become pregnant (females) or father a child (males) during study and 4 months after last dose
- Unwillingness to use effective contraception during study and 4 months after last dose
- Recent chemotherapy, radiotherapy, biological therapy, targeted therapy, or major surgery within 14 days before study start without recovery
- Participation in another investigational drug or device study within 3 weeks before treatment
- Psychiatric or substance abuse disorders interfering with study cooperation
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited 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 Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
E
Edmund Bartlett, MD
CONTACT
C
Charlotte Ariyan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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