Evaluating Dostarlimab with Niraparib Versus Niraparib Alone and Chemotherapy for Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After Chemotherapy

What this Trial Is About

Researchers are investigating treatments for gynecological carcinosarcomas, including ovarian and uterine carcinosarcomas, which are rare and aggressive cancers with poor survival rates. After initial treatments like surgery and chemotherapy, most patients experience relapse with limited options and poor outcomes. This trial aims to improve understanding and treatment options for these difficult-to-treat cancers using new therapies. The study evaluates three treatment approaches: niraparib alone, a combination of niraparib with dostarlimab (an anti-PD-1 drug), and standard chemotherapy regimens. Niraparib is taken daily in doses of 200 mg or 300 mg. The combination therapy involves niraparib plus intravenous infusions of dostarlimab given every 21 days for four cycles, then every 42 days. Chemotherapy options vary depending on whether the cancer is ovarian or endometrial, with drugs like paclitaxel, doxorubicin, and gemcitabine administered intravenously on specific schedules. Participants will be monitored through clinical evaluations, imaging scans, and laboratory tests to assess tumor response and survival outcomes. Researchers will measure response rates at 4 months and overall survival at 1 year after enrollment completion. Secondary outcomes include progression-free survival, time to next treatment, adverse events, and patient-reported quality of life. Safety and treatment effects will be closely followed throughout the study duration, which extends until 2029.

Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib