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
1 other identifier
interventional
30
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2020
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 23, 2026
April 1, 2026
7 years
April 1, 2020
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
6 months
Study Arms (1)
Participants with Sarcoma
EXPERIMENTALAdvanced/metastatic extremity sarcoma eligible for pembrolizumab and isolated limb infusion (ILI)
Interventions
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.
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 dactinomycin
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Publications (1)
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.
PMID: 34722269DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edmund Bartlett, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 3, 2020
Study Start
April 1, 2020
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.