Phase III Study Comparing Doxorubicin With or Without Pembrolizumab for Treating Metastatic or Unresectable Dedifferentiated Liposarcoma, Undifferentiated Pleomorphic Sarcoma, and Related Sarcomas

What this Trial Is About

Researchers are evaluating the effect of combining immunotherapy pembrolizumab with chemotherapy doxorubicin compared to chemotherapy alone in patients with dedifferentiated liposarcoma DDLPS, undifferentiated pleomorphic sarcoma UPS, or related poorly differentiated sarcomas that have spread or cannot be removed by surgery. This phase III trial aims to determine if the combination helps patients live longer without disease progression. The study also assesses overall survival, response rates, and safety of the treatments. Participants are randomly assigned to one of two groups. One group receives doxorubicin intravenously every 21 days for up to 6 cycles along with pembrolizumab intravenously every 21 days for up to 2 years if there is no disease progression or unacceptable side effects. The other group receives doxorubicin alone for up to 6 cycles, and if the disease progresses, pembrolizumab may be started for up to 2 years. Both groups undergo heart function tests ECHO or MUGA scan, standard imaging scans, and blood sample collections during the study. Participants are evaluated regularly with imaging and laboratory tests to monitor tumor response and side effects. After completing treatment, they are followed up every 3 months for 2 years, then every 6 months up to 10 years to track long-term outcomes. The main outcome measured is progression-free survival, which is the time from randomization to cancer progression or death. Safety and overall survival are also monitored throughout the study period.

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