About this trial
This clinical trial looks at how well immunotherapy with pembrolizumab works with chemotherapy using doxorubicin for patients with aggressive types of sarcoma. The goal is to see if this combination helps patients live longer without their cancer getting worse, compared to doxorubicin alone. This study involves patients whose cancer cannot be removed by surgery or has spread to other parts of the body.
The trial's ID number is NCT06422806. This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. It is FDA-regulated and aims to include about 365 participants.
Who can join
Anyone aged 18 and older can join. This trial is open to men and women with a confirmed diagnosis of certain types of poorly differentiated sarcoma. Patients should not be pregnant or breastfeeding. The trial team will check if potential participants meet all requirements.
Conditions
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants are randomly assigned to one of two groups. In Arm A, patients receive both doxorubicin and pembrolizumab. In Arm B, patients start with doxorubicin alone and may receive pembrolizumab later if their cancer progresses. Both groups will have regular scans and blood tests throughout the study.
Where
This trial is running at 245 locations in the United States. 239 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Advocate Christ Medical Center
Oak Lawn, Illinois
Advocate Good Samaritan Hospital
Downers Grove, Illinois
Advocate Good Shepherd Hospital
Barrington, Illinois
Advocate Illinois Masonic Medical Center
Chicago, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois
Advocate Outpatient Center - Aurora
Aurora, Illinois
Advocate Sherman Hospital
Elgin, Illinois
The first 8 of 245 sites are listed here. The registry record has the full list.