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SarcomaPhase 2NCT04332874

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

A Phase 2 study testing Isolated Limb Infusion, Pembrolizumab and infusion of melphalan and dactinomycin in people with Sarcoma and Myxofibrosarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Isolated Limb Infusion, Pembrolizumab and infusion of melphalan and dactinomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesUnited States
Study dates
1 Apr 2020to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Edmund Bartlett, MD contact

212-639-2448

bartlete@mskcc.org

Charlotte Ariyan, MD, PhD contact

212-639-6280

ariyanc@mskcc.org

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

    Basking Ridge, New Jersey, 07920

    Edmund Barlett, MD, 212-639-2448

    Recruiting

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

    Commack, New York, 11725

    Edmund Barlett, MD, 212-639-2448

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Edmund Barlett, MD, 212-639-2448

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748

    Edmund Barlett, MD, 212-639-2448

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Edmund Barlett, MD, 212-639-2448

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Edmund Bartlett, MD, 212-639-2448

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Edmund Barlett, MD, 212-639-2448

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of Concurrent Systemic Pembrolizumab and Isolated Limb Infusion (ILI) With Melphalan and Dactinomycin for Patients With Locally Advanced or Metastatic Extremity Sarcoma

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).

Being tested
Isolated Limb Infusion, Pembrolizumab, infusion of melphalan and dactinomycin
Keywords
Sarcoma, Myxofibrosarcoma, Undifferentiated Pleomorphic Sarcoma, Alveolar Soft Part Sarcoma, Pembrolizumab, Isolate Limb Infusion, Melphalan, Dactinomycin, Metastatic Extremity Sarcoma, Locally Advanced Sarcoma, 20-104, Memorial Sloan Kettering Cancer Center
Medical subject headings
Sarcoma, Dermatofibrosarcoma, Histiocytoma, Malignant Fibrous, Sarcoma, Alveolar Soft Part

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isolated Limb InfusionProcedure or surgery

    Also called ILI

    ILI will be performed within 18 days of initiation of pembrolizumab. ILI (infusion of melphalan and dactinomycin into the affected limb via arterial catheter) will be performed in the interventional radiology suite under anesthesia. In pediatric patients, the pediatric pharmacist w ill be consulted prior to the procedure, and an appropriate prophylactic anti-emetic therapy and dose will be selected for the individual patient.

  • PembrolizumabDrug

    Pembrolizumab at a dose of 200 mg will be administered intravenously on Day 1 and every 3 weeks(+/= 3 days) thereafter. In adolescent patients, the dosing of pembrolizumab w ill be 2 mg/kg up to a maximum of 200 mg.

  • infusion of melphalan and dactinomycinDrug

    infusion of melphalan and dactinomycin

Study groups in NCT04332874
Study groupRoleWhat they receive
Participants with SarcomaExperimentalAdvanced/metastatic extremity sarcoma eligible for pembrolizumab and isolated limb infusion (ILI)
Receives: Procedure: Isolated Limb Infusion; Drug: Pembrolizumab; Drug: infusion of melphalan and dactinomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start1 Apr 2020
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332874
Sponsor's protocol ID
20-104
Status last verified
Apr 2026
First submitted
1 Apr 2020
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Bartlett EK, D'Angelo SP, Kelly CM, Siegelbaum RH, Fisher C, Antonescu CR, Ariyan CE. Case Report: Response to Regional Melphalan via Limb Infusion and Systemic PD1 Blockade in Recurrent Myxofibrosarcoma: A Report of 2 Cases. Front Oncol. 2021 Oct 15;11:725484. doi: 10.3389/fonc.2021.725484. eCollection 2021.

    PubMed 34722269

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isolated Limb Infusion, Pembrolizumab and infusion of melphalan and dactinomycin in people with Sarcoma and Myxofibrosarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edmund Bartlett, MD (212-639-2448, bartlete@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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