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Endometrial cancer – Trials in Disease

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Clinical Trials for Endometrial Cancer

There are currently 35 ongoing clinical trials investigating new treatments for endometrial cancer, also known as uterine cancer or cancer of the endometrium. These studies are taking place across multiple countries in Europe and are testing various innovative approaches including immunotherapy drugs, targeted therapies, chemotherapy combinations, and maintenance treatments. The trials range from early phase studies evaluating safety and dosing to large-scale studies comparing new treatments against standard care.

Clinical trial locations

Study for Patients with BRCA Mutated Ovarian, Breast, Pancreatic, Prostate, and Endometrial Cancers Continuing Olaparib Treatment

This study focuses on patients who have completed previous cancer studies using olaparib and continue to benefit from this treatment. The trial aims to provide ongoing access to olaparib for eligible patients with various BRCA-mutated cancers, including endometrial cancer.

Main inclusion criteria: Patients must have previously participated in an AstraZeneca oncology study with olaparib and be experiencing clinical benefit from the treatment as determined by their doctor. They must provide signed informed consent and continue to meet the eligibility criteria from their previous study.

Main exclusion criteria: Patients without BRCA mutations or those not experiencing clinical benefit from olaparib treatment are excluded. The study is also limited to specific cancer types, and patients outside the defined age range or not meeting other health criteria cannot participate.

Main focus/goal: The trial provides continuous treatment with olaparib while monitoring safety and tolerability. It tracks serious adverse events and ensures patients who respond well to olaparib can continue their treatment. The study follows patients throughout their treatment period, assessing both effectiveness and safety.

Investigational drug: Olaparib is a PARP inhibitor that interferes with cancer cells’ ability to repair DNA damage, thereby slowing or stopping cancer growth. In this trial, it is provided as film-coated tablets in 100 mg and 150 mg doses, taken orally according to individual treatment needs.

Study of AZD8205 Alone or with Other Cancer Drugs for Patients with Advanced Breast, Biliary Tract, Ovarian, and Endometrial Cancer

This trial evaluates a new treatment called AZD8205 for advanced cancers including endometrial cancer. The study tests AZD8205 both alone and in combination with other anticancer medications to determine the safest and most effective dosing approach.

Main inclusion criteria: Participants must be at least 18 years old with confirmed advanced or metastatic solid tumors that have progressed after standard treatment. For endometrial cancer specifically, patients must have documented disease progression and have tried PARP inhibitors or bevacizumab if eligible. Good venous access and adequate organ function are required.

Main exclusion criteria: Patients with cancer types other than those specified in the study cannot participate. Those outside the specified age range or belonging to vulnerable populations are also excluded.

Main focus/goal: The study evaluates safety and tolerability of AZD8205, both as a single treatment and combined with other drugs. Researchers will monitor tumor response using imaging tests and assess organ function through regular evaluations. The trial aims to identify the optimal dose for future studies.

Investigational drug: AZD8205 is administered intravenously and targets specific molecular pathways involved in cancer cell growth. This early-stage medication is being investigated for its potential to shrink or control tumors in various advanced cancers.

Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers

This study examines AZD9574, a new medication tested both alone and with other anticancer treatments for various advanced solid tumors. The trial includes patients with specific genetic mutations and investigates both safety and initial effectiveness.

Main inclusion criteria: Patients must be at least 18 years old with good physical functioning ability and adequate organ and bone marrow function. They should have advanced cancer that is progressing, confirmed through testing, and meet specific criteria based on their cancer type. Participants must have a life expectancy of at least 12 weeks and good heart function.

Main exclusion criteria: Patients without the specific types of cancer or genetic mutations being studied are excluded. Those with certain breast cancer features, such as brain metastases, or outside the study’s age range cannot participate.

Main focus/goal: The trial assesses safety and tolerability of AZD9574, examining how the body processes the medication and its initial effectiveness against cancer. Researchers evaluate both single-agent and combination therapy approaches through regular monitoring and dose adjustment based on individual response.

Investigational drug: AZD9574 is an oral medication in film-coated tablet form that targets specific molecular pathways involved in cancer cell growth and survival. It is being studied for its potential to treat advanced solid tumors with particular genetic characteristics.

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This clinical trial investigates DS-3939a, a new treatment for various advanced cancers including endometrial cancer. The study is divided into phases focusing first on safety and dose determination, then on effectiveness at the recommended dose.

Main inclusion criteria: Patients must be adults who have signed informed consent and have adequate organ function. They need measurable disease according to specific criteria and an ECOG performance status of 0-1, meaning they can carry out daily activities with minimal limitations. Heart function must show a left ventricular ejection fraction of at least 50%.

Main exclusion criteria: Patients with metastatic or advanced solid tumors outside the study’s focus, those not meeting age requirements, or belonging to vulnerable populations cannot participate. Those not meeting safety and tolerability requirements for the study drug are also excluded.

Main focus/goal: Phase 1 determines the maximum tolerated dose and recommended Phase 2 dose of DS-3939a. Phase 2 evaluates the medication’s effectiveness in reducing or controlling tumors at the recommended dose. Throughout both phases, researchers closely monitor patient health and tumor response.

Investigational drug: DS-3939a is administered through intravenous infusion and is designed to target specific cancer cell pathways. The trial aims to understand its safety profile and potential effectiveness in treating advanced solid tumors.

Study of E7386 and Lenvatinib for Patients with Liver, Colon, Endometrial, or Other Solid Tumors

This trial examines the combination of E7386 and Lenvima (lenvatinib) for treating various solid tumors including endometrial cancer. The study evaluates both safety and effectiveness of this drug combination.

Main inclusion criteria: Patients must have confirmed diagnosis of one of the specified cancers, including endometrial cancer, with adequate liver, kidney, and bone marrow function. They must have measurable disease, a life expectancy of at least 12 weeks, and an ECOG performance status of 0-1. Body weight must exceed 30 kg.

Main exclusion criteria: Patients not meeting safety and tolerability requirements, those outside the specified age range, or belonging to vulnerable populations are excluded. Those with inadequate organ function or other serious health conditions cannot participate.

Main focus/goal: The study assesses safety and tolerability of E7386 combined with lenvatinib, determining optimal dosing for future research. Researchers monitor how well the treatment controls cancer growth, measuring tumor response and tracking treatment duration over up to 26 weeks.

Investigational drug: E7386 is an oral medication in tablet form that inhibits specific proteins involved in cancer cell growth. It is being tested in combination with lenvatinib (hard capsules, 10 mg or 4 mg doses) to evaluate effectiveness against various solid tumors.

Study of PC14586 for Patients with Advanced Solid Tumors with a Specific TP53 Mutation

This study focuses on PC14586, a treatment for advanced solid tumors carrying a specific TP53 Y220C mutation. The trial evaluates both effectiveness and safety of this targeted therapy for patients with particular genetic tumor characteristics.

Main inclusion criteria: Patients must be at least 18 years old with ECOG status of 0 or 1, able to understand study procedures and provide consent. They must have confirmed locally advanced or metastatic solid tumors with TP53 Y220C mutation verified through testing. Previous standard treatment must have been received or deemed inappropriate. Adequate organ function is required.

Main exclusion criteria: Patients without the TP53 Y220C mutation or those with tumors that are not locally advanced or metastatic are excluded. Those outside the specified age range or belonging to vulnerable populations cannot participate.

Main focus/goal: The trial evaluates safety and effectiveness of PC14586 while monitoring for side effects. Regular assessments track tumor response through imaging and other tests. The study aims to determine if this medication can help control or reduce tumors with this specific genetic mutation.

Investigational drug: PC14586 is taken orally as film-coated tablets and works by targeting and stabilizing the mutated form of the p53 protein involved in controlling cell division. This investigational anti-cancer agent is being evaluated for tumors with the specific TP53 Y220C mutation.

Study of Pembrolizumab for Patients with Mismatch Repair Deficient Uterine Cancer

This Dutch trial investigates pembrolizumab (KEYTRUDA) as treatment before surgery for a specific type of endometrial cancer characterized by mismatch repair deficiency. The study aims to evaluate how well this immunotherapy approach works when given before surgical removal of the tumor.

Main inclusion criteria: Female participants at least 18 years old with confirmed mismatch repair deficient (MMRd) uterine cancer who are planning to undergo hysterectomy. Participants must not be pregnant or breastfeeding and must agree to use contraception during treatment. Written informed consent is required.

Main exclusion criteria: Male patients and those without confirmed MMRd/MSI-H endometrial cancer cannot participate. The study excludes vulnerable populations.

Main focus/goal: The study evaluates whether pembrolizumab given before surgery can achieve a major pathologic response, meaning 10% or less remaining viable tumor after treatment. Researchers monitor safety and assess recurrence-free survival for up to 2 years from diagnosis. Treatment consists of 9 cycles of pembrolizumab followed by standard hysterectomy.

Investigational drug: Pembrolizumab (KEYTRUDA) is administered as intravenous infusion at 500 mg per dose. This immunotherapy works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively.

Study of Trastuzumab Deruxtecan, Rilvegostomig, and Pembrolizumab for Advanced or Recurrent Endometrial Cancer in HER2-Positive Patients

This large multinational study compares different treatment combinations for HER2-expressing, mismatch repair proficient endometrial cancer. Participants receive either trastuzumab deruxtecan with immunotherapy or standard chemotherapy with pembrolizumab.

Main inclusion criteria: Patients must be at least 18 years old with adequate organ and bone marrow function. They must have confirmed HER2-expressing (IHC 3+ or 2+), pMMR endometrial carcinoma that is either primary advanced (Stage III/IV) or first recurrent. Heart function must be adequate with left ventricular ejection fraction of at least 50%. No prior first-line systemic anticancer therapy is allowed, except for certain conditions.

Main exclusion criteria: Previous treatment with antibody-drug conjugates or immune checkpoint inhibitors, tumors without required HER2 expression levels, dMMR status, active or untreated brain metastases, history of interstitial lung disease, significant heart problems, active autoimmune disease, or active infections are excluded.

Main focus/goal: The study compares progression-free survival and overall survival among three treatment groups. Researchers evaluate tumor response through regular imaging, monitor side effects, and assess quality of life. Treatment continues until disease progression or unacceptable toxicity.

Investigational drugs: Trastuzumab Deruxtecan targets HER2 proteins on cancer cells, delivering cytotoxic agents directly. Rilvegostomig enhances immune system response, while pembrolizumab blocks PD-1 to help immune recognition of cancer cells. Standard chemotherapy includes carboplatin and paclitaxel, both interfering with cancer cell division.

Study of Tulmimetostat (CPI-0209) for Patients with Advanced Solid Tumors and Lymphomas

This trial evaluates CPI-0209, an oral medication for various advanced cancers and lymphomas including endometrial cancer. The study progresses through dose-escalation to dose-confirmation phases to establish optimal treatment approaches.

Main inclusion criteria: Adults 18 years or older with advanced or metastatic tumors that have progressed after standard treatment or lack effective standard treatment options. Patients must have life expectancy of at least 12 weeks, tumor tissue available for testing, ECOG performance status of 0 or 1, and adequate bone marrow, kidney, and liver function. Blood and tumor samples for testing specific markers must be provided.

Main exclusion criteria: Patients not fully recovered from previous treatments, those with other serious health conditions, pregnant or breastfeeding women, recent cancer history (within 5 years), active infections, heart conditions, uncontrolled hypertension, autoimmune diseases, organ transplant history, or recent live vaccine receipt are excluded.

Main focus/goal: Phase 1 determines the maximum tolerated dose and recommended Phase 2 dose of CPI-0209 as monotherapy. Phase 2 evaluates antitumor activity in selected advanced solid tumors and lymphomas at the recommended dose. Throughout both phases, safety and effectiveness are closely monitored.

Investigational drug: CPI-0209 is taken orally as film-coated tablets and works by inhibiting specific proteins that cancer cells use to grow and survive. This investigational cancer therapy aims to disrupt cancer cell mechanisms.

Study on Durvalumab for Patients with High-Risk Endometrial Cancer After Surgery

This trial investigates durvalumab as treatment after surgery for mismatch-repair deficient high-risk endometrial cancer. The study aims to prevent cancer recurrence in patients who have undergone surgical removal of their tumors.

Main inclusion criteria: Female patients with confirmed diagnosis of specific endometrial cancer types (endometrioid, serous, clear cell, dedifferentiated, undifferentiated, carcinosarcoma, or mixed) with MMRd status and non-pathogenic POLE status. Patients must have WHO Performance score of 0-1, life expectancy of at least 12 weeks, adequate organ function, and no prior pelvic radiotherapy. Surgery must have included hysterectomy and bilateral salpingo-oophorectomy with no visible residual disease.

Main exclusion criteria: Patients without confirmed MMRd HREC, those with POLE mutations, male patients, those with residual disease or distant metastases after surgery, and vulnerable populations are excluded.

Main focus/goal: The RAINBO trial aims to improve three-year disease-free survival by studying how durvalumab can prevent cancer recurrence after surgery. The study monitors patients for up to three years, assessing cancer-free survival and overall health.

Investigational drug: Durvalumab (Imfinzi) is administered through IV infusion at 50 mg/mL concentration. This immunotherapy blocks the PD-L1 protein, helping the immune system recognize and attack cancer cells more effectively.

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

This study evaluates a combination treatment approach for newly diagnosed advanced or recurrent endometrial cancer. Patients receive chemotherapy with durvalumab initially, followed by maintenance therapy with either durvalumab alone or durvalumab plus olaparib.

Main inclusion criteria: Female patients at least 18 years old with confirmed epithelial endometrial carcinoma (all types except sarcomas). The cancer must be newly diagnosed Stage III-IV or recurrent disease that cannot be cured with surgery or radiation alone. Patients must have an ECOG performance status of 0 or 1, adequate organ function, and MMRd/MSI-H tumor status confirmed before joining. A tissue sample must be available for MMR evaluation.

Main exclusion criteria: Male patients and those without MMR deficient relapsed or advanced/metastatic endometrial cancer are excluded. Vulnerable populations are not included in this study.

Main focus/goal: The trial compares progression-free survival between treatment arms, evaluating chemotherapy (paclitaxel and carboplatin) combined with durvalumab followed by maintenance therapy. The study monitors how long patients live without cancer progression and assesses overall survival and safety.

Investigational drugs: Durvalumab is an immunotherapy given by IV infusion that blocks PD-L1 protein. Olaparib is a PARP inhibitor taken orally that interferes with cancer cells’ DNA repair. Both carboplatin and paclitaxel are chemotherapy drugs given by IV infusion that stop cancer cell growth.

Summary

The 35 ongoing clinical trials for endometrial cancer represent a comprehensive research effort across Europe, with particularly strong participation from countries like France, Spain, Italy, Germany, and Poland. Several notable patterns emerge from this landscape of research.

Immunotherapy dominance: A significant proportion of trials involve pembrolizumab (marketed as KEYTRUDA), an immune checkpoint inhibitor that helps the body’s immune system fight cancer. This drug appears in multiple studies, both as a single agent and in various combinations, reflecting the important role immunotherapy has taken in endometrial cancer treatment.

Targeted therapy focus: Many trials investigate targeted therapies like olaparib (a PARP inhibitor), lenvatinib, and durvalumab, often in combination approaches. These medications target specific molecular features of cancer cells, representing a more personalized approach to treatment compared to traditional chemotherapy.

Molecular classification emphasis: Several studies specifically focus on molecularly defined subgroups, particularly those with mismatch repair deficiency (dMMR/MSI-H) or HER2 expression. This molecular classification approach allows for more tailored treatment selection based on tumor characteristics.

Maintenance therapy interest: Multiple trials examine maintenance therapy approaches using drugs like navtemadlin, selinexor, and olaparib after initial chemotherapy response. These studies aim to extend the time patients remain cancer-free following successful initial treatment.

Combination strategies: Many trials test novel drug combinations, such as immunotherapy plus targeted therapy, or immunotherapy plus chemotherapy. This reflects growing understanding that combination approaches may be more effective than single-agent treatments for many patients.

The geographic distribution shows strong European collaboration, though some countries like Sweden, Netherlands, and Denmark host unique trials examining specific approaches such as biomarker-based staging or neoadjuvant immunotherapy. The diversity of approaches being tested offers hope that treatment options for endometrial cancer will continue to improve in coming years.

Ongoing Clinical Trials on Endometrial cancer

  • Study for Patients with BRCA Mutated Ovarian, Breast, Pancreatic, Prostate, and Endometrial Cancers Continuing Olaparib Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Hungary +6

  • Study of Pembrolizumab for Patients with Mismatch Repair Deficient Uterine Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Olaparib and Bevacizumab for Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety and Effects of Farletuzumab Ecteribulin for Patients with Ovarian, Breast, Endometrial, and Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • Study of E7386 and Lenvatinib for Patients with Liver, Colon, Endometrial, or Other Solid Tumors

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study of PC14586 for Patients with Advanced Solid Tumors with a Specific TP53 Mutation

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • Study on Olaparib for Patients with p53abn Endometrial Cancer After Chemoradiation Therapy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Durvalumab for Patients with High-Risk Endometrial Cancer After Surgery

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Italy The Netherlands

  • Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Study on Dostarlimab and Niraparib for Patients with Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

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