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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 1, 2020

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2026

Conditions
SarcomaMyxofibrosarcomaUndifferentiated Pleomorphic SarcomaAlveolar Soft Part Sarcoma
Interventions
PROCEDURE

Isolated 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.

DRUG

Pembrolizumab

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.

DRUG

infusion of melphalan and dactinomycin

infusion of melphalan and dactinomycin

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

RECRUITING

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

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER