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RecruitingMetastatic Dedifferentiated LiposarcomaMetastatic Undifferentiated Pleomorphic SarcomaStage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

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

Eligible age

18+ yrs

Accepts

All genders

Locations

36 states

Healthy volunteers

No

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About this study

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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

  • ✓ Patient must be \>= 18 years of age
  • ✓ Patient must have a confirmed histopathologic diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to:
  • ✓ Pleomorphic sarcoma with inflammation or with limited areas of differentiation
  • ✓ Pleomorphic sarcoma with giant cells
  • ✓ Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
  • ✓ Myxofibrosarcoma
  • ✓ Poorly differentiated sarcoma not otherwise specified (NOS)
  • ✓ Undifferentiated spindle cell sarcoma

Where it's recruiting

Arizona

Phoenix · Tucson

California

Dublin · Fremont · Fresno · La Jolla …

Colorado

Aurora · Fort Collins · Greeley · Loveland

Connecticut

Derby · Fairfield · Greenwich · Guilford …

Delaware

Millville · Newark · Rehoboth Beach

Florida

Coral Gables · Coral Springs · Deerfield Beach · Gainesville …

Georgia

Atlanta

Hawaii

Honolulu

Idaho

Boise · Caldwell · Coeur d'Alene · Nampa …

Illinois

Aurora · Barrington · Bloomington · Canton …

Indiana

Crown Point · Indianapolis

Iowa

Ankeny · Carroll · Clive · Des Moines …

Source: ClinicalTrials.gov · NCT06422806 · last updated 2026-10-26

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemothera · TrialPath