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

RECRUITINGPHASE2

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

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

NCT04332874•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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 disease gets worse (progresses).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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%
+12 more criteria

Exclusion Criteria

•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.
+10 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

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

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

April 1, 2020

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

SarcomaMyxofibrosarcomaUndifferentiated Pleomorphic SarcomaAlveolar Soft Part Sarcoma

Interventions

Isolated Limb Infusion

PROCEDURE

Pembrolizumab

DRUG

infusion of melphalan and dactinomycin

DRUG

Contacts

Edmund Bartlett, MD

CONTACT

212-639-2448 bartlete@mskcc.org

Charlotte Ariyan, MD, PhD

CONTACT

212-639-6280 ariyanc@mskcc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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