Ongoing Clinical Trials for Endometrial Cancer Stage III
Two clinical trials are currently recruiting patients with stage III endometrial cancer across multiple countries in Europe. These studies focus on testing immunotherapy medication dostarlimab, either alone or in combination with chemotherapy drugs, to evaluate new treatment approaches for patients with advanced disease.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- Finland
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Spain
- Sweden
Study of dostarlimab treatment before surgery in patients with stage II-III endometrial cancer with specific genetic markers
This trial is testing dostarlimab as a treatment given before surgery in patients with stage II-III endometrial cancer. The study focuses specifically on patients whose tumors have certain genetic characteristics known as MMRd (mismatch repair deficiency) or MSI-H (high microsatellite instability). These genetic markers indicate that the tumor cells have specific DNA repair defects that may make them more responsive to immunotherapy.
Who can participate: The trial is open to women aged 18 years or older who have newly diagnosed stage II or III endometrioid endometrial cancer with confirmed MMRd status. Participants must be able to perform daily activities with minimal restrictions and must not have received any previous cancer treatments such as radiation or hormone therapy. Adequate organ function is required, including normal blood cell counts, liver function, and kidney function. Women of childbearing potential must use highly effective contraception and cannot be pregnant or breastfeeding.
Who cannot participate: Men are excluded from the study, as are women younger than 18 years. Patients without confirmed MMRd/MSI-H markers or those with cancer stages other than II-III are not eligible. The trial also excludes patients who are currently participating in other clinical studies, those who are pregnant or breastfeeding, individuals with severe allergic reactions to similar medications, and patients with uncontrolled medical conditions.
Treatment approach: Participants receive dostarlimab at a dose of 500 mg through intravenous infusion. The medication is administered before surgery to evaluate how well it can shrink the tumor. Throughout the treatment, which can last up to 66 weeks, doctors use imaging tests such as MRI, CT scans, and PET scans to monitor how the cancer responds. After evaluating the response, doctors determine whether surgery is necessary or if the cancer has responded completely to the immunotherapy alone.
About the medication: Dostarlimab is an immunotherapy drug that works by blocking a protein called PD-1 on immune cells. This blocking action helps the immune system recognize and attack cancer cells more effectively. The medication is particularly suited for tumors with MMRd/MSI-H characteristics because these tumors tend to be more responsive to this type of immune-based treatment.
Study on Dostarlimab, Carboplatin, and Paclitaxel for Patients with Recurrent or Advanced Endometrial Cancer
This trial investigates whether adding dostarlimab to standard chemotherapy can improve outcomes for patients with recurrent or advanced endometrial cancer. The study combines the immunotherapy drug dostarlimab with two chemotherapy medications, carboplatin and paclitaxel, and compares this combination to chemotherapy with a placebo. The trial also includes a second part where some patients receive an additional medication called niraparib.
Who can participate: Women aged 18 years or older with confirmed endometrial cancer that is either recurring or in an advanced stage (Stage III or IV) may be eligible. Participants must have cancer that has a low chance of being cured by radiation or surgery alone. This includes primary Stage IIIA to IIIC1 disease with visible tumors, Stage IIIC2 or Stage IV disease, or first recurrence of the disease. Patients must be able to perform normal activities or have only minor symptoms and must have adequate organ function, including proper levels of blood cells, kidney function, and liver function. Women of childbearing age must use effective contraception and cannot be pregnant or breastfeeding.
Who cannot participate: The trial excludes patients who have a different type of cancer other than endometrial cancer or those who are not in Stage III or IV. Men are not eligible, and the study specifies that it is designed for female patients only.
Treatment approach: The study is designed as a double-blind trial, meaning neither patients nor researchers know who receives the actual medication or placebo. Patients are randomly assigned to receive either dostarlimab with chemotherapy or a placebo with chemotherapy. The treatment involves intravenous infusions of dostarlimab combined with carboplatin and paclitaxel. In the second part of the study, some patients also receive niraparib, which is taken orally. Throughout the trial, patients undergo regular medical assessments, imaging tests, and laboratory evaluations to monitor disease progression and treatment effects.
About the medications: Dostarlimab is an immunotherapy drug that helps the immune system attack cancer cells by blocking the PD-1 receptor. Carboplatin and paclitaxel are chemotherapy drugs that work by interfering with cancer cell growth and division. Niraparib is a targeted therapy known as a PARP inhibitor, which prevents cancer cells from repairing their DNA, leading to their death. The combination of these medications aims to provide a more comprehensive approach to treating advanced endometrial cancer.
Summary
Currently, two clinical trials are available for patients with stage III endometrial cancer, both focusing on the immunotherapy drug dostarlimab. The trials take different approaches: one tests dostarlimab alone before surgery in patients with specific genetic markers, while the other combines it with standard chemotherapy for recurrent or advanced disease.
The first trial is available in Spain and specifically targets patients whose tumors have MMRd or MSI-H characteristics. This study explores whether immunotherapy alone, given before surgery, can effectively treat the cancer and potentially avoid or delay the need for surgery.
The second trial is much more widely available, recruiting patients across 13 European countries including Germany, Greece, Italy, Denmark, Finland, Hungary, Poland, Spain, Netherlands, Norway, Sweden, Czechia, and Belgium. This broader trial accepts patients with various types of stage III and stage IV disease and evaluates whether adding immunotherapy to chemotherapy improves survival outcomes compared to chemotherapy alone.
Both studies reflect the growing interest in immunotherapy as a treatment option for endometrial cancer, particularly for patients with advanced disease. The availability of these trials across multiple European countries provides opportunities for patients to access potentially beneficial new treatment approaches while contributing to medical research.
