Ongoing Clinical Trials for Metastatic Endometrial Cancer
Currently, there are 3 ongoing clinical trials investigating new treatment approaches for patients with metastatic endometrial cancer. These studies are testing different combinations of immunotherapy drugs and targeted therapies, with trials being conducted across several European countries including Italy, Spain, France, Germany, Belgium, Czechia, and Greece.
Clinical trial locations
- Belgium
- Czechia
- France
- Germany
- Greece
- Italy
- Spain
- Study on Dostarlimab and Niraparib for Patients with Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma
- Study of Durvalumab and Tremelimumab for Patients with Colorectal and Endometrial Cancer
- Study on Selinexor as Maintenance Therapy for Patients with Advanced or Recurrent Endometrial Cancer After Chemotherapy
Study on Dostarlimab and Niraparib for Patients with Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma
This trial is investigating treatment options for patients with a specific and aggressive form of cancer called carcinosarcoma that affects either the uterus or ovaries and has either spread to other parts of the body or returned after previous treatment. The study is available in Italy, France, and Spain.
Main inclusion criteria: To participate, you must be female and at least 18 years old with confirmed progressive or recurrent uterine carcinosarcoma. You need to have a life expectancy of more than 2 months and must have already received at least one prior platinum-containing chemotherapy treatment. Your body must have adequate bone marrow function, with platelet counts of at least 100,000 per mm³, absolute neutrophil count of at least 1,500 per mm³, and hemoglobin greater than 9 g/dL. Your liver and kidney function must also be adequate, with specific requirements for bilirubin, creatinine, and liver enzyme levels. If you are of childbearing potential, you must have a negative pregnancy test and agree to avoid pregnancy during the study and for 180 days afterward. You must be able to take oral medications and have an ECOG Performance Status of 0 or 1, meaning you can perform most daily activities.
Main exclusion criteria: You cannot participate if you have a different type of cancer than metastatic or recurrent endometrial or ovarian carcinosarcoma. Only female patients are eligible. You must have received at least one line of chemotherapy for your condition to be eligible. Patients considered part of a vulnerable population, such as those with limited ability to protect their own interests, are not eligible.
Trial focus: The study is evaluating the effectiveness of two medications used in different combinations. Participants will be randomly assigned to receive either a combination of dostarlimab and niraparib, niraparib alone, or standard chemotherapy. The trial has two phases: the first aims to select the most effective treatment strategy, and the second will further evaluate the chosen strategy. Throughout the study, patients will be monitored for how long they live without the cancer getting worse, overall survival, and the safety of the treatments.
Investigational drugs: Dostarlimab is an immune checkpoint inhibitor that helps your immune system recognize and attack cancer cells. It is given as an infusion directly into the bloodstream at a dose of 500 mg. Niraparib belongs to a class of drugs called PARP inhibitors, which work by blocking a protein that cancer cells need to repair themselves. This can help stop the cancer from growing. Niraparib is taken as a capsule by mouth at a dose of 100 mg.
Study of Durvalumab and Tremelimumab for Patients with Colorectal and Endometrial Cancer
This trial is examining two types of cancer—colorectal and endometrial—focusing on specific genetic characteristics called microsatellite stable (MSS) and microsatellite instable (MSI). The study is currently being conducted in Spain.
Main inclusion criteria: You must be over 18 years old and capable of giving signed informed consent, meaning you understand the study and agree to participate. You need to have at least one tumor that is at least 10 mm in size and can be biopsied. Your ECOG performance status must be 0 or 1, meaning you are fully active or have some symptoms but do not need bed rest during the day. For one group of participants (Cohort 1), you must have colorectal or endometrial cancer that has returned or spread and cannot be treated with surgery, with specific genetic characteristics known as MSI-H or dMMR. For another group (Cohort 2), you must have colorectal cancer that has worsened after certain treatments or endometrial cancer that has worsened after specific treatments, with known MSS or pMMR status. You must have a life expectancy of more than 12 weeks and weigh more than 30 kg. Your organ and bone marrow function must be normal, meeting specific levels for hemoglobin, neutrophils, platelets, and kidney function. If you are a woman of childbearing potential, you must have a negative pregnancy test and agree to use birth control during the study and for a certain period after.
Main exclusion criteria: You cannot participate if you have other types of cancer that are not MSS or MSI colorectal or endometrial tumors. Patients who have received other cancer treatments that might interfere with the study drugs, have severe or uncontrolled medical conditions, are pregnant or breastfeeding, have had an organ transplant, have active infections including HIV or hepatitis, have a history of severe allergic reactions to similar drugs, or are unable to comply with study procedures are not eligible.
Trial focus: The study is testing two immunotherapy medications—durvalumab and tremelimumab—either alone or in combination. The goal is to understand how well these treatments can help shrink tumors or stop them from growing. Researchers will conduct regular assessments including physical exams, blood tests, and imaging studies to monitor your response to treatment. The study will also analyze cancer cells at a detailed level to understand how they react to treatment and identify any changes that may provide insights for future therapies.
Investigational drugs: Durvalumab is an immunotherapy medication that helps your immune system recognize and attack cancer cells by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer. It is given as an intravenous infusion directly into a vein. Tremelimumab is also an immunotherapy drug that enhances the body’s immune response against cancer cells by targeting a protein called CTLA-4. It is administered as an intravenous infusion at a dose of 300 mg, followed by durvalumab. Both medications are immune checkpoint inhibitors designed to boost the immune system’s ability to fight cancer.
Study on Selinexor as Maintenance Therapy for Patients with Advanced or Recurrent Endometrial Cancer After Chemotherapy
This trial is investigating selinexor as a maintenance therapy for patients who have completed chemotherapy for advanced or recurrent endometrial cancer. The study is taking place in Italy, Spain, Germany, Czechia, Belgium, and Greece.
Main inclusion criteria: You must be female and at least 18 years old with a confirmed diagnosis of endometrial cancer of specific types: endometrioid, serous, or undifferentiated. A type called carcinosarcoma of the uterus is also allowed. You must have completed at least 12 weeks of a specific chemotherapy treatment (taxane-platinum combination) for advanced cancer or after the first relapse, and be in partial or complete remission—meaning the cancer has either shrunk or disappeared. You must be able to start the study drug 5 to 8 weeks after finishing your last dose of chemotherapy. Your ECOG performance status must be 0-1, meaning you are fully active or have some symptoms but can still carry out light work. Your liver, blood, and kidney function must meet specific requirements, including total bilirubin up to 1.5 times the normal limit, adequate levels of liver enzymes, an absolute neutrophil count of at least 1.5 x 10⁹/L, a platelet count of at least 100 x 10⁹/L, hemoglobin of at least 9.0 g/dL, and estimated creatinine clearance of at least 30 mL/min. You must have a life expectancy of at least 12 weeks. If you are premenopausal and able to have children, you must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months after the last dose.
Main exclusion criteria: You cannot participate if you do not have endometrial cancer. Only female patients are eligible. Patients younger than 18 years old or older than 65 years old cannot participate. Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
Trial focus: This is a double-blind study, meaning neither you nor the researchers will know whether you are receiving selinexor or a placebo (a substance with no active medication). The purpose is to evaluate how effective selinexor is as a maintenance therapy to help keep the cancer from coming back after initial chemotherapy treatment. The maximum treatment period is four months. The main goal is to assess progression-free survival—the length of time during and after treatment that you live with the disease without it getting worse. The study will also evaluate time to subsequent therapies, overall survival, safety and tolerability of the treatment, and your quality of life using specific questionnaires.
Investigational drug: Selinexor is taken orally as a tablet. It works by blocking certain proteins in cancer cells, which may help to slow down or stop the growth of cancer. Specifically, selinexor blocks a protein that helps cancer cells grow and survive. It is classified as a selective inhibitor of nuclear export (SINE) compound. This trial is testing whether selinexor can improve outcomes for patients with advanced or recurrent endometrial cancer compared to a placebo.
Summary
The three ongoing clinical trials for metastatic endometrial cancer reflect a diverse approach to treatment, utilizing both immunotherapy and targeted therapies. Geographically, Spain has the broadest access with participation in all three trials, while Italy participates in two studies. Other countries including France, Germany, Belgium, Czechia, and Greece each host one or two trials, indicating a wide European research network.
A notable observation is the focus on immunotherapy combinations, with two trials investigating immune checkpoint inhibitors (dostarlimab with niraparib, and durvalumab with tremelimumab). These approaches aim to harness the body’s immune system to fight cancer. The third trial takes a different approach by examining maintenance therapy with selinexor, which works by blocking proteins that cancer cells need to survive, helping to prevent cancer recurrence after chemotherapy.
The trials also vary in their target populations: one focuses specifically on carcinosarcoma (a rare and aggressive form), another examines tumors based on genetic characteristics (MSS and MSI status), and the third targets patients who have completed initial chemotherapy and achieved remission. This variety ensures that different patient groups with varying disease characteristics have access to potentially beneficial new treatments.
Patients interested in participating should note that eligibility requirements vary between trials, particularly regarding prior treatments, specific cancer subtypes, and overall health status. All trials emphasize the importance of adequate organ function and performance status, ensuring patient safety throughout the study period.
