Ongoing Clinical Trials for Recurrent Endometrial Cancer
There are currently 4 ongoing clinical trials investigating new treatments for recurrent endometrial cancer. These trials are testing combinations of immunotherapy, targeted therapies, and chemotherapy across multiple European countries. Patients with advanced or recurrent disease who have previously received platinum-based chemotherapy may be eligible to participate in these studies.
Clinical trial locations
- Belgium
- Czechia
- France
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Spain
- Study on the Safety and Effectiveness of IMGN151 for Women with Recurrent Endometrial and Ovarian Cancer
- Study on Durvalumab, Olaparib, and Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer in Spain
- Study on Selinexor as Maintenance Therapy for Patients with Advanced or Recurrent Endometrial Cancer After Chemotherapy
- Study on the Safety and Effectiveness of Lurbinectedin and Dostarlimab for Patients with Advanced Endometrial Cancer After Platinum-based Chemotherapy
Study on the Safety and Effectiveness of IMGN151 for Women with Recurrent Endometrial and Ovarian Cancer
This trial is investigating IMGN151, an antibody-drug conjugate designed to target and attack cancer cells more precisely. The study is being conducted in France, Spain, Belgium, Ireland, Netherlands, Germany, and Italy.
Main inclusion criteria: Women aged 18 or older who have completed major surgery at least 4 weeks before starting treatment and have recovered. Patients must have adequate blood, liver, and kidney function, and a performance status allowing them to be fully active or able to carry out light work. For the dose-escalation phase, participants must have confirmed recurrent cancer that has not responded to standard treatments. For the expansion phase, specific treatment history and conditions apply. Tumor tissue samples must be provided for testing.
Main exclusion criteria: Male patients and those who are not part of a vulnerable population cannot participate.
Focus of the trial: The study has two main phases. The first phase tests different doses of IMGN151 to find the safest and most effective dose. The second phase gives the chosen dose to more patients to further assess effectiveness. Throughout the trial, participants will be closely monitored for side effects and to see how their cancer responds to treatment. The main goal is to determine the best dose of IMGN151 that can be safely given and to evaluate how well it works in treating these cancers.
Investigational drug: IMGN151 is an experimental antibody-drug conjugate that combines an antibody with a drug to specifically target and kill cancer cells. It is delivered directly into the bloodstream through intravenous infusion. The study also involves the use of eye drops (Pred Forte 1% and Brimonidine Tartrate 0.2%) to manage any ocular symptoms or side effects.
Study on Durvalumab, Olaparib, and Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer in Spain
This trial is evaluating a combination treatment approach in Spain for women with advanced or recurrent disease.
Main inclusion criteria: Women aged 18 years or older with adequate organ and bone marrow function, including hemoglobin of at least 10.0 g/dL, neutrophil count of at least 1.5 x 10⁹/L, and platelet count of at least 100 x 10⁹/L. Patients must have confirmed diagnosis of endometrial carcinoma with pMMR tumors. Eligible disease stages include newly diagnosed Stage III with measurable disease, newly diagnosed Stage IV, or recurrent disease where surgery alone is unlikely to cure. Patients must not have received first-line systemic anti-cancer treatment, except for previous treatment at least 6 months prior in recurrent disease cases. At least one tumor sample block must be available, and patients must have an ECOG performance status of 2 or less.
Main exclusion criteria: Patients with other types of cancer besides advanced or recurrent disease, those who have previously received the study drugs, those with serious health conditions that could interfere with treatment, pregnant or breastfeeding women, patients with known allergies to the study drugs, those unable to follow study procedures, patients with certain infections or diseases, and those participating in another clinical trial simultaneously.
Focus of the trial: The study aims to understand the safety of using durvalumab with platinum-based chemotherapy, followed by durvalumab and olaparib as a first treatment option. The treatment course begins with durvalumab infusion combined with platinum-based chemotherapy. After this initial phase, patients continue with durvalumab and olaparib tablets. Throughout the study, participants’ health and progress are closely monitored to gather information on side effects and cancer response to treatment.
Investigational drugs: Durvalumab is an immunotherapy medication that blocks a protein called PD-L1, helping the immune system detect and attack cancer cells. It is given as an intravenous infusion. Platinum-based chemotherapy refers to treatments containing platinum that damage cancer cell DNA to prevent growth and division. Olaparib is a PARP inhibitor taken orally that interferes with cancer cells’ ability to repair damaged DNA, leading to their death.
Study on Selinexor as Maintenance Therapy for Patients with Advanced or Recurrent Endometrial Cancer After Chemotherapy
This trial is investigating Selinexor as maintenance therapy after combination chemotherapy. The study is being conducted in Italy, Spain, Germany, Czechia, Belgium, and Greece.
Main inclusion criteria: Female patients at least 18 years old with confirmed diagnosis of endometrial cancer including endometrioid, serous, or undifferentiated types. Cancer must be proficient in mismatch repair (pMMR) as determined by immunohistochemistry. Disease must have progressed after one prior treatment with platinum-based chemotherapy for advanced or recurrent disease. Patients must have an ECOG performance status of 0 or 1 and measurable disease according to RECIST v.1.1 criteria. At least three weeks must have passed since last cancer treatment with recovery to mild level from side effects. Tumor tissue samples must be available, and patients must have adequate bone marrow, kidney, liver, and metabolic function. Women of childbearing potential must use highly effective birth control.
Main exclusion criteria: Male patients, those who have not experienced disease progression after prior platinum-based chemotherapy, patients with cancer that is not advanced or recurrent, those not proficient in mismatch repair, and patients considered part of a vulnerable population.
Focus of the trial: The study is designed as a double-blind trial where participants are randomly assigned to receive either Selinexor or a placebo. The main goal is to assess progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse. Other aspects being evaluated include time to first and second subsequent therapies, overall survival, safety and tolerability of treatment, and quality of life using specific questionnaires. The maximum treatment period is four months.
Investigational drug: Selinexor is taken orally as film-coated tablets and works by blocking proteins in cancer cells that may help slow down or stop cancer growth. It is classified as a selective inhibitor of nuclear export (SINE) compound and is being studied to determine if it can help keep cancer from coming back after initial treatment.
Study on the Safety and Effectiveness of Lurbinectedin and Dostarlimab for Patients with Advanced Endometrial Cancer After Platinum-based Chemotherapy
This trial is being conducted in Spain and focuses on patients whose cancer has progressed after previous platinum-based chemotherapy.
Main inclusion criteria: Patients must be over 18 years old with confirmed diagnosis of endometrial cancer including endometrioid, clear cell, high-grade serous, undifferentiated carcinoma, or mixed types. Cancer must be proficient in mismatch repair (pMMR) determined by immunohistochemistry. Disease must have progressed after one prior treatment with platinum-based chemotherapy for advanced or recurrent disease. Patients must have an ECOG performance status of 0 or 1 and measurable disease according to RECIST v.1.1 criteria. At least three weeks must have passed since last cancer treatment with recovery from side effects. Available tumor tissue samples from a previous non-irradiated lesion are required. Patients must have adequate bone marrow, kidney, liver, and metabolic function including sufficient platelets, hemoglobin, neutrophils, normal liver enzyme levels, good kidney function, and enough serum albumin. Women of childbearing potential must use highly effective birth control.
Main exclusion criteria: Patients who have not experienced disease progression after prior platinum-based chemotherapy, those with cancer that is not advanced or recurrent, male patients, those not proficient in mismatch repair (pMMR), and patients considered part of a vulnerable population.
Focus of the trial: The study is conducted in two phases. In the first phase, researchers determine the best dose of lurbinectedin to use in combination with dostarlimab. In the second phase, they assess how well this combination works in shrinking tumors in patients whose cancer has progressed after previous chemotherapy. Both medications are given through intravenous infusion. Participants are monitored for side effects and how well the cancer responds to treatment. The trial is expected to continue until 2026.
Investigational drugs: Lurbinectedin is an antineoplastic agent that works by binding to DNA in cancer cells, disrupting their transcription process, which leads to cell death. Dostarlimab is an immune checkpoint inhibitor that blocks the PD-1 receptor on immune cells, enhancing the body’s immune response against cancer cells. Both medications are administered intravenously and are being studied in combination to determine if they are more effective together than either medication alone.
Summary
All four clinical trials are investigating innovative treatment approaches for recurrent endometrial cancer in patients who have received prior platinum-based chemotherapy. Spain is notably active in this research field, hosting three of the four trials. The studies explore different therapeutic strategies including antibody-drug conjugates, immunotherapy combinations, PARP inhibitors, and maintenance therapies.
A common requirement across these trials is that participants must have proficient mismatch repair (pMMR) tumors, indicating a specific molecular characteristic of the cancer. The trials employ various approaches: IMGN151 targets cancer cells directly through a specialized antibody-drug conjugate, the durvalumab-olaparib combination pairs immunotherapy with DNA repair inhibition, Selinexor acts as maintenance therapy to prevent recurrence, and the lurbinectedin-dostarlimab combination merges DNA-targeting treatment with immune system enhancement.
Most trials require adequate organ function and an ECOG performance status indicating patients can maintain daily activities. The research spans multiple European countries, with Spain, Germany, Belgium, and Italy participating in multiple studies, providing broader access to these experimental treatments for eligible patients across Europe.
