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OncoMatch/Clinical Trials/NCT04332874

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

Is NCT04332874 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and infusion of melphalan and dactinomycin for sarcoma.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT04332874Data as of May 2026

Treatment: Pembrolizumab · infusion of melphalan and dactinomycinThe 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).

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG OR KPS 0–2

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

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)

Kidney function

Serum creatinine <= 1.5 x ULN or a measured or calculated creatinine clearance >= 60 mL/min for a patient with creatinine levels > 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)

Liver function

Serum bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN for a patient with total bilirubin level > 1.5 x ULN; AST <= 2.5 x ULN OR <= 5 x ULN for patients with liver metastases; ALT <= 2.5 x ULN OR <= 5 x ULN for patients with liver metastases; Alkaline phosphatase < 5 x ULN

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 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; Alanine aminotransferase (ALT) <= 2.5 x ULN OR <= 5 x ULN for patients with liver metastases; Alkaline phosphatase < 5 x ULN; Serum creatinine <= 1.5 x ULN or a measured or calculated creatinine clearance >= 60 mL/min for a patient with creatinine levels > 1.5 x institutional ULN (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. GFR can also be used in place of creatinine or CrCl); INR or PT <= 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; aPTT <= 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities) · Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (Limited protocol activities) · Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) · Commack, New York
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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