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.
Treatment: Doxorubicin · Pembrolizumab — This 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.
Check if I qualifyExtracted 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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