RecruitingPhase 2NCT04332874

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

30 participants

Start Date

Apr 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining pembrolizumab (an immunotherapy drug) with isolated limb infusion — a technique that delivers a high concentration of chemotherapy directly into an arm or leg — can improve outcomes for people with advanced sarcoma (a cancer of connective tissue) affecting a limb. **You may be eligible if...** - You are 12 years or older - You have a confirmed diagnosis of advanced or metastatic sarcoma in an arm or leg - You have already received at least one prior cancer treatment (chemotherapy, immunotherapy, or targeted therapy) or have decided not to pursue the standard option - You are eligible for both pembrolizumab and the isolated limb infusion procedure based on your doctor's assessment - You are in reasonably good physical condition (ECOG 0–2) - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - Your sarcoma is not located in a limb - You have not yet received any prior systemic cancer treatment (and are still eligible for standard options) - You have conditions that make the limb procedure or immunotherapy unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIsolated Limb Infusion

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.

DRUGPembrolizumab

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.

DRUGinfusion of melphalan and dactinomycin

infusion of melphalan and dactinomycin


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

View Full Details on ClinicalTrials.gov

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NCT04332874


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