New combo targets sarcoma in limbs
NCT ID NCT04332874
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether combining the immunotherapy drug pembrolizumab with chemotherapy drugs (melphalan and dactinomycin) delivered directly to the affected limb via isolated limb infusion can safely delay cancer growth. It enrolls 30 patients aged 12 and older with advanced sarcoma in an arm or leg. The goal is to see if the disease stays stable for at least 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab, melphalan, dactinomycin
- What this could lead to
- If successful, this combination could delay cancer progression in the affected limb, offering a new option for patients with advanced sarcoma.
- What could go wrong
- This is a small, early-phase trial (30 participants) focused on safety and progression delay, not a cure. Side effects from chemotherapy and immunotherapy may occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2020
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients must fulfill all of the following criteria to be eligible for admission to the study. Any exceptions from the protocol-specific selection criteria must be approved by the Principal Investigator and/or the Institutional Review Board (IRB) before enrollment. * 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 Creatinine clearance should be calculated per institutional standard. For female patients of childbearing potential, negative serum pregnancy test at screening visit and within 72 h prior to the first dose of study medication. Exclusion Criteria: Patients who fulfil any of the following criteria are not eligible for admission to the study: * 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. (Women not of childbearing potential are defined as: post-menopausal \[age \> 55 years with cessation of menses for 12 or more months or less than 55 years but not spontaneous menses for at least 2 years or less than 55 years and spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \> 40 IU/L) or postmenopausal estradiol levels (\< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved\] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited protocol activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?