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.
Belgium
