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OncoMatch/Clinical Trials/NCT06422806

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

Is NCT06422806 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pembrolizumab and Doxorubicin for metastatic dedifferentiated liposarcoma.

Phase 3RecruitingNational Cancer Institute (NCI)NCT06422806Data as of May 2026

Treatment: Doxorubicin · PembrolizumabThis phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.

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Extracted eligibility criteria

Cancer type

Sarcoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anthracycline

Patient must not have had prior treatment with an anthracycline

Cannot have received: anti-PD-1 therapy

Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent

Cannot have received: pericardial or mediastinal radiation

Patient must not have had prior pericardial or mediastinal radiation

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1,500 cells/uL; Platelets ≥ 75,000 cells/uL

Kidney function

Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula

Liver function

Total bilirubin < 1.2 mg/dL; AST and ALT ≤ 3.0 × institutional upper limit of normal (ULN)

Cardiac function

Left ventricular ejection fraction (LVEF) > 50% by either MUGA scan or echocardiogram; NYHA class 2B or better

Absolute neutrophil count (ANC) ≥ 1,500 cells/uL; Platelets ≥ 75,000 cells/uL; Total bilirubin < 1.2 mg/dL; AST and ALT ≤ 3.0 × institutional upper limit of normal (ULN); Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula; Left ventricular ejection fraction (LVEF) > 50% by either MUGA scan or echocardiogram; NYHA class 2B or better

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

US trial sites

  • Illinois CancerCare-Dixon · Dixon, Illinois
  • Mayo Clinic Hospital in Arizona · Phoenix, Arizona
  • Banner University Medical Center - Tucson · Tucson, Arizona
  • University of Arizona Cancer Center-North Campus · Tucson, Arizona
  • Kaiser Permanente Dublin · Dublin, California

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

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