A Phase 3 Study of Doxorubicin Alone or With Pembrolizumab to Advanced Sarcomas

Full Title

A Randomized Phase III Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas (EA7222) (CIRB)

Purpose

Researchers are comparing treatment with doxorubicin chemotherapy and pembrolizumab immunotherapy to doxorubicin alone for advanced sarcoma. The people in this study have undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Their cancers have metastasized (spread) or are inoperable (cannot be taken out with surgery).

If you take part in this study, you will be randomly assigned to get doxorubicin alone or with pembrolizumab. Doxorubicin is a standard chemotherapy drug. Pembrolizumab works by taking the brakes off the immune system so it can find and kill cancer cells.

Both drugs are given intravenously (by vein). People who get doxorubicin alone may receive pembrolizumab if their cancer gets worse despite doxorubicin.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic UPS or a related poorly differentiated sarcoma.
  • Have recovered from the serious side effects of any prior anti-cancer treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

 

Contact

For more information and to see if you can join this study, please call Dr. Robert Maki’s office at 646-888-5059.

Protocol

25-239

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06422806