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Study Comparing Chemotherapy Alone to Dostarlimab, Paclitaxel, and Carboplatin for Patients with Advanced or Metastatic Endometrial Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for endometrial cancer, specifically in patients with a type of genetic change known as MMR deficiency. Endometrial cancer affects the lining of the uterus and can become advanced or spread to other parts of the body, which is referred to as metastatic. The study is comparing the effectiveness of a new treatment using a medication called Dostarlimab against standard chemotherapy treatments. Chemotherapy involves using drugs to kill cancer cells, and in this study, the drugs being used are Paclitaxel and Carboplatin. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see if Dostarlimab can help patients live longer without their cancer getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to receive either Dostarlimab or the standard chemotherapy treatment. The study will last for a period of time, during which participants will receive their assigned treatment and be monitored regularly to check on their health and the status of their cancer. The study will also look at other important outcomes, such as overall survival, quality of life, and how well the cancer responds to the treatment.

Throughout the study, participants will have regular check-ups and assessments to monitor their progress. These assessments may include imaging tests and other evaluations to see how the cancer is responding to the treatment. The study aims to provide valuable information about the potential benefits of Dostarlimab for patients with advanced or metastatic endometrial cancer, helping to improve future treatment options for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving chemotherapy alone and the other receiving chemotherapy combined with dostarlimab.
The study focuses on patients with a specific type of endometrial cancer that is advanced or has returned after treatment.
Step 2
Treatment administration
The treatment involves the administration of three medications: paclitaxel, dostarlimab, and carboplatin. All medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
The specific dosage and frequency of these medications will be determined by the study protocol and the patient's individual health condition.
Step 3
Monitoring and assessments
Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular assessments to check for any progression of the cancer and to evaluate the effectiveness of the treatment.
The main goal is to measure progression-free survival, which is the length of time during and after the treatment that the patient lives with the disease without it getting worse.
Step 4
End of treatment
The treatment will continue until the study's end date or until the patient experiences significant disease progression or unacceptable side effects.
The estimated end date for the study is December 31, 2029.
Step 5
Follow-up
After the treatment phase, there will be a follow-up period to monitor the patient's overall survival and quality of life.
Additional assessments may be conducted to evaluate the long-term effects of the treatment and any subsequent therapies.

Who can join the trial?

15 criteria

The patient must be a female who is at least 18 years old.
The patient must sign an agreement to participate and be able to follow the study's requirements.
The patient must have a type of cancer called endometrial adenocarcinoma that has come back or is advanced.
The patient must have a performance status score of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must have a specific stage of cancer (Stage IIIA to C2 or Stage IV) or a first recurrence of endometrial cancer that cannot be cured with surgery or radiation alone.
The patient must have cancer that can be measured or evaluated according to specific guidelines.
The patient may have had previous chemotherapy for the primary cancer and had a recurrence at least 6 months after finishing treatment.
All types of endometrial adenocarcinoma can be included if they have certain characteristics called **MMRd**/**MSI-H**.
The tumor must have **MMRd**/**MSI-H** status, which means it has specific genetic features. This will be confirmed before joining the study.
The patient must provide a sample for testing to confirm **MMR**/**MSI** status.
The patient may have been treated with hormone therapy for advanced or metastatic disease.
The patient may have received certain types of radiation therapy.
The patient must have adequate organ function, which means their blood and organ tests must meet specific levels.
The patient must have a negative pregnancy test before starting the study medication, unless they cannot have children.
If the patient can have children, they must agree to use a highly effective method of birth control during the study and for 180 days after the last dose of study treatment.

Who cannot join the trial?

3 criteria

Patients who do not have **MMR deficient** relapse or advanced/metastatic endometrial cancer. **MMR deficient** means that the cancer cells have a problem with a system that usually fixes mistakes in DNA.
Patients who are not female, as the study is only for female participants.
Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.

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Verified sites

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Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

Dostarlimab is a medication being studied for its potential to treat endometrial cancer. It is being tested in patients with advanced or metastatic cancer that is deficient in a specific repair mechanism known as MMR. The trial is comparing the effectiveness of this medication when used alone versus traditional chemotherapy. The goal is to see if it can help patients live longer without their cancer getting worse.

What is already known about the treatment

Dostarlimab – Dostarlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating patients with MMR deficient relapse or advanced/metastatic endometrial cancer. It is a monoclonal antibody that works by blocking the PD-1 receptor, which helps the immune system recognize and attack cancer cells. This medication is classified as an immune checkpoint inhibitor. The main therapeutic indication for Dostarlimab is to improve progression-free survival in patients with specific types of endometrial cancer.

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 often presents with symptoms such as abnormal vaginal bleeding or discharge, pelvic pain, and weight loss. As the cancer progresses, it may spread to other parts of the body, including the ovaries, fallopian tubes, and lymph nodes. The progression of the disease can vary, with some cases remaining localized while others become more advanced or metastatic. Factors such as genetic mutations, including MMR deficiency, can influence the behavior and progression of the cancer.