Clinical Trials | EA7222: Measuring if Immunotherapy Plus Chemotherapy is better than Chemotherapy Alone for Patients with Aggressive Poorly Differentiated Sarcomas

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas. The purpose of this study is to compare the usual treatment of doxorubicin alone to using an immunotherapy called pembrolizumab (MK-3475) plus the usual treatment of doxorubicin. The addition of pembrolizumab (MK-3475) to the usual treatment could be more effective at controlling the cancer. Both drugs doxorubicin and pembrolizumab (MK-3475) are already approved by the FDA for use in many cancers. However, the use together is considered investigational. Investigational means that their use in combination has not been approved by the U.S. Food and Drug Administration This study has two study arms. Arm A will receive doxorubicin in combination with pembrolizumab (MK-3475). Arm B will receive doxorubicin alone. You and your treating provider will know which arm you are assigned. You will be assigned to one of the arms through a process called “randomization” which means that your doctor will not choose and you cannot choose which study arm you are in. You will have 50% chance of being in Arm A or Arm B. The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging, and talking to the study doctor. If you choose to take part and are deemed eligible for participation, you will receive treatment one time (on day 1) per cycle (every 21 days). You will receive treatment based on the arm that you have been assigned to (either doxorubicin alone or doxorubicin in combination with pembrolizumab (MK-3475)). Regardless of which treatment you are randomized to, you will receive doxorubicin for up to six cycles. After you finish doxorubicin, your doctor will continue to follow you for up to 10 years and watch you for side effects and growth of the cancer with scans every 3 months. If you are randomized to doxorubicin alone, you will be observed off treatment with periodic imaging which is the standard way. If your cancer progresses, you will be allowed to receive the pembrolizumab immunotherapy for up to two years as part of the study. If you are randomized to receive doxorubicin together with pembrolizumab (MK-3475) you will continue to receive pembrolizumab (MK-3475) for up to two years on the study. You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your sarcoma. You or your insurance provider will not have to pay for the pembrolizumab (MK-3475) while you take part in this study. Additional information can be found here: https://www.clinicaltrials.gov/study/NCT06422806 [email protected]