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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Isolated Limb Infusion
  • Pembrolizumab
  • infusion of melphalan and dactinomycin

Treatment groups

30 Participants
are divided into 1 treatment group