Endometrial cancer stage IV Trials in Disease

Study on Dostarlimab, Carboplatin, and Paclitaxel for Patients with Recurrent or Advanced Endometrial Cancer

This clinical trial is testing new treatment options for women with recurrent or advanced Stage IV endometrial cancer, a cancer that begins in the lining of the uterus. The study is evaluating whether adding an immunotherapy drug called Dostarlimab to standard chemotherapy can help delay cancer recurrence or improve survival rates.

Main focus and goal: The trial aims to determine if combining Dostarlimab, a type of monoclonal antibody that helps the immune system fight cancer cells, with chemotherapy drugs Carboplatin and Paclitaxel can be more effective than chemotherapy alone. The study is divided into two parts. In the first part, patients receive either Dostarlimab with chemotherapy or a placebo with chemotherapy. In the second part, some patients also receive an additional drug called Niraparib. This is a double-blind study, meaning neither patients nor researchers know who receives the actual medication or placebo, ensuring unbiased results.

Investigational drugs: The main drug being tested is Dostarlimab, also known as TSR-042, which is an immune checkpoint inhibitor that blocks the PD-1 receptor to help the immune system recognize and attack cancer cells. It is given through intravenous infusion in combination with two chemotherapy drugs: Carboplatin, which interferes with cancer cell DNA to prevent growth, and Paclitaxel, which stops cancer cells from dividing. In the second part of the study, some patients will also receive Niraparib, a PARP inhibitor taken orally that prevents cancer cells from repairing their DNA.

Main inclusion criteria: To participate in this trial, patients must be:

• Female and at least 18 years old
• Diagnosed with confirmed endometrial cancer that is either recurring or in advanced stages (Stage III or IV)
• Able to provide a tumor tissue sample for testing
• Either newly diagnosed with primary Stage III or IV disease, or experiencing a first recurrence of the cancer that cannot be cured by surgery or radiation alone
• In good overall health with an ECOG performance status of 0 or 1, meaning they are fully active or have some symptoms but do not need bed rest
• Have adequate organ function, including sufficient levels of blood cells, kidney and liver function
• Willing to use effective contraception if of childbearing potential
• For Part 2 only: have normal or controlled blood pressure and be able to take oral medication

Main exclusion criteria: Patients cannot participate if they:

• Have a type of cancer other than endometrial cancer
• Do not have Stage III or IV endometrial cancer
• Are male
• Are considered part of a vulnerable population with limited ability to give informed consent
• Have uterine sarcoma