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Study on the Safety and Effectiveness of Lurbinectedin and Dostarlimab for Patients with Advanced Endometrial Cancer After Platinum-based Chemotherapy

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What is this study about?

This clinical trial is focused on studying a treatment for endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study is specifically for patients whose cancer has advanced or returned after previous treatment with platinum-based chemotherapy. The treatment being tested involves two medications: lurbinectedin and dostarlimab. Lurbinectedin is a chemical compound, while dostarlimab is a type of protein-based medication. Both are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the combination of lurbinectedin and dostarlimab in treating patients with advanced or recurrent endometrial cancer. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of lurbinectedin to use in combination with dostarlimab. In the second phase, they will assess how well this combination works in shrinking tumors in patients whose cancer has progressed after previous chemotherapy.

Participants in the study will receive the treatment and be monitored for any side effects and how well the cancer responds to the treatment. The study aims to provide valuable information on whether this combination of medications can be a beneficial treatment option for patients with advanced or recurrent endometrial cancer. The trial is expected to continue until 2026, with recruitment starting in 2024.

1 joining the study

Upon joining the study, the patient will provide written consent to participate. This is a necessary step before any study-related procedures can begin.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of advanced or recurrent endometrial cancer and ensuring previous treatment with platinum-based chemotherapy.

The assessment will also check the patient’s overall health, including blood tests to evaluate bone marrow, liver, and kidney function.

3 treatment phase I

In the first phase, the patient will receive a combination of two medications: lurbinectedin and dostarlimab. Both are administered through an intravenous infusion.

The goal of this phase is to determine the safest and most effective dose of the medications. The patient will be closely monitored for any side effects.

4 treatment phase II

In the second phase, the patient will continue receiving the combination of lurbinectedin and dostarlimab at the dose determined in phase I.

The focus of this phase is to evaluate the effectiveness of the treatment in reducing tumor size and controlling the disease.

5 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment will be regularly monitored through medical examinations and imaging tests.

The patient will also be evaluated for any side effects or adverse reactions to the medications.

6 end of trial

The trial is expected to conclude by September 2026. At the end of the trial, the patient’s overall response to the treatment will be assessed.

The patient will receive information about the results and any further steps regarding their treatment plan.

Who Can Join the Study?

  • You must voluntarily sign and date a written informed consent before any specific study procedure.
  • You need to be over 18 years old.
  • You must have a confirmed diagnosis of endometrial cancer, which is a type of cancer that starts in the lining of the uterus. This can include different types like endometrioid, clear cell, high-grade serous, undifferentiated carcinoma, or mixed types.
  • Your cancer must be proficient in mismatch repair (pMMR), which means your cancer cells can fix certain types of DNA damage. This is determined by a test called immunohistochemistry (IHC).
  • Your disease must have progressed after one prior treatment with platinum-based chemotherapy for advanced or recurrent disease. If your disease progressed less than 1 year after finishing this treatment, you are eligible without further treatment. If it progressed 1 year or more after treatment, and cannot be treated with radiation or surgery, you must have had one more type of systemic treatment before joining the study.
  • You may have had prior hormonal or biological therapies, like targeted therapies, but not immunotherapy. These do not count as previous treatments.
  • You must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
  • You must have measurable disease according to specific criteria called RECIST v.1.1. This means your cancer can be measured on scans. If you had radiation treatment, those areas can be measured if the disease has clearly progressed.
  • At least three weeks must have passed since your last cancer treatment, including radiotherapy, and you must have recovered to a mild level from any side effects of previous treatments, except for certain conditions like mild nerve damage, anemia, weakness, and hair loss.
  • You must have available tumor tissue samples from a previous non-irradiated lesion. These samples should be freshly prepared or prepared within 6 months of use.
  • Your body must be functioning well in terms of bone marrow, kidneys, liver, and metabolism. This includes having enough platelets, hemoglobin, and neutrophils in your blood, normal liver enzyme levels, normal bilirubin levels, a normal blood clotting measure called INR, good kidney function, normal levels of an enzyme called CPK, and enough serum albumin, which is a protein in your blood.
  • If you are a woman who can have children, you must show evidence that you are not currently able to have children. You must agree to use a highly effective form of birth control during the trial and for at least six months after the last dose of the study treatment. Acceptable methods include abstinence, an intrauterine device (IUD), oral contraceptives, a subdermal implant, or using two forms of barrier protection. Male partners of women who can have children should use condoms during treatment and for four months after the last dose of the study medicine.

Who Cannot Join the Study?

  • Patients who have not experienced disease progression after prior therapy with platinum-based chemotherapy.
  • Patients with a type of endometrial cancer that is not advanced or recurrent.
  • Patients who are male, as the study is only for female subjects.
  • Patients who are not proficient in mismatch repair (pMMR), which is a condition where the body’s system for fixing DNA mistakes is working properly.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Ispmdtun Cglyyj Doucfieckrdkmvwem L'hospitalet De Llobregat Spain
Hbbjnyiu Vktx dwrcvwmc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.03.2024

Trial locations

Investigated drugs:

Lurbinectedin is a medication being studied for its potential to treat advanced or recurrent endometrial cancer. It is used in patients whose cancer has progressed after receiving platinum-based chemotherapy. The goal of using lurbinectedin in this trial is to determine the best dose that can be safely given to patients and to evaluate how effective it is in reducing the size of tumors.

Dostarlimab is another medication involved in this study. It is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this trial, dostarlimab is combined with lurbinectedin to see if the combination is more effective in treating advanced or recurrent endometrial cancer than using either medication alone. The study aims to assess the safety and effectiveness of this combination therapy in patients who have not responded well to previous treatments.

Investigated diseases:

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in women who have gone through menopause. The disease can progress from localized growths in the uterine lining to more invasive forms that spread to other parts of the body. Advanced or recurrent endometrial cancer refers to cases where the cancer has returned or continued to grow despite initial treatments. In some patients, the cancer may not respond to standard therapies, such as platinum-based chemotherapy, leading to further progression. The progression of the disease can vary, with some cases remaining stable for extended periods while others may advance more rapidly.

Trial ID:
2023-508583-30-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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