Pembrolizumab with Isolated Limb Infusion for Sarcoma in the Arm or Leg
This study is testing a treatment for sarcoma in your arm or leg. It combines pembrolizumab, an immunotherapy that helps your body's immune system fight cancer, with chemotherapy drugs melphalan and dactinomycin. These chemotherapy drugs are given directly to the affected limb using a procedure called Isolated Limb Infusion (ILI). Researchers want to see if this combination is safe and can delay the time until the sarcoma gets worse. The study is open to people aged 12 and older, and aims to enroll 30 participants. The current status of recruitment is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 30 participants, but the phase of the study is not specified.
- What's involved
- You would receive pembrolizumab intravenously every three weeks. The Isolated Limb Infusion (ILI) procedure, involving melphalan and dactinomycin, would be performed within 18 days of starting pembrolizumab.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures how long you live without the disease progressing, with a focus on this at 6 months.
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NCT04332874
A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg
Recruiting
PHASE2Ages 12+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~30 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Isolated Limb InfusionPembrolizumabinfusion of melphalan and dactinomycin
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over 6 months
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Edmund Bartlett, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>/= 12 years at the time of informed consent
Willing and able to provide written informed consent/assent for the trial
Willing to comply with treatment protocol
Have a histologically confirmed metastatic and/or locally advanced sarcoma
Eligible for standard treatment with pembrolizumab
Eligible for an isolated limb infusion (ILI) as determined by the treating physician
Have undergone at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) or have declined the standard of care systemic option.
Have measurable disease (at least one index lesion) as defined by RECIST 1.1 or by clinical measurement for superficial lesions not amenable to radiographic surveillance. Index lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
Adequate performance status: ECOG \</= 2 or KPS \>/= 60%
Adequate organ function determined within 3 weeks of treatment initiation, defined as follows:
Hemoglobin \>/= 8.0 g/dL
Absolute neutrophil count \>/= 1,000/mm\^3 (1.0 x 10\^9/L)
Platelet count \>/= 50,000/mm\^3 (50 x 10\^9/L)
Serum bilirubin \</= 1.5 x upper limit of normal (ULN) OR direct bilirubin \</= ° ° ULN for a patient with total bilirubin level \> 1.5 x ULN Aspartate aminotransferase (AST) \</= 2.5 x ULN OR \</= 5 x ULN for patients with liver metastases
Alanine aminotransferase (ALT) \</= 2.5 x ULN OR \</= 5 x ULN for patients with liver metastases
Alkaline phosphatase \< 5 x ULN
Serum creatinine \</= 1.5 x ULN or a measured or calculated creatinine clearance \>/= 60 mL/min for a patient with creatinine levels \> 1.5 x institutional ULN (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. GFR can also be used in place of creatinine or CrCl)
International normalized ratio (INR) or prothrombin time (PT) \</= 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) \</= 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants
Exclusion
Have any other malignancy that requires active treatment
Ineligible for ILI because of underlying physical conditions (e.g. coronary artery disease with inability to tolerate anesthesia) as determined by treating physician
Has previously experienced hypersensitivity to pembrolizumab or any of its excipients
Has uncontrolled intercurrent illness including active infection requiring systemic therapy or symptomatic congestive heart failure within the past 6 months
Has known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study Day 1 and return to baseline of neurologic symptoms), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include sarcomatous meningitis, which is excluded regardless of clinical stability.
Shows evidence of clinically significant immunosuppression such as the following:
Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
Concurrent opportunistic infection
Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator.
Has a known active or chronic infection with HIV if CD4 count is less than 500.
Has a known active infection with hepatitis B or hepatitis C
Has a known history of active tuberculosis infection
Has history or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in the past 2 years. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
For female subjects, is pregnant or breast-feeding, or planning to become pregnant
For male subjects, is planning to father a child within the projected duration of the trial, starting with the pre-screening or screening visit, during study treatment and through 4 months after the last dose of pembrolizumab
For patients of childbearing potential, is unwilling to use acceptable method(s) of effective contraception during study treatment and through 4 months after the last dose of pembrolizumab.
Underwent prior chemotherapy, radiotherapy, biological cancer therapy, targeted small molecule therapy, or major surgery within 14 days prior to study Day 1 or has not recovered (i.e., to CTCAE \</= grade 1 or at baseline) from adverse events due to previously administered therapy. Patients with \</= grade 2 neuropathy and alopecia are an exception and may qualify for the study. If patients received major surgery, they must have recovered adequately prior to starting therapy.
Is currently participating and receiving study therapy with another investigational device or study drug or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
What this trial measures
- Progression free survival6 months
Progression free survival at 6 months by RECIST 1.1 among all participants treated with the combination of ILI using melphalan and dactinomycin plus pembrolizumab