Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Categories (click each to see list of all clinical trials associated with that category): Sarcoma (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Abughanimeh, Omar
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06422806?term=NCT06422806&rank=1#participation-criteria
Summary
2.1 Primary Objective
2.1.1 To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.
2.2 Key Secondary Objective
2.2.1 To assess whether the combination of doxorubicin and pembrolizumab vs the re introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS).
2.3 Secondary Objectives
2.3.1 To evaluate the safety and tolerability in each treatment arm
2.3.2 To quantify overall response rate (ORR) and durability of response (DOR) in each treatment.