Study of dostarlimab treatment before surgery in patients with stage II-III endometrial cancer with specific genetic markers

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What is this study about?

This study focuses on patients with endometrial cancer, specifically stage II-III disease with certain genetic characteristics (MMRd/MSI-H). Endometrial cancer is a type of cancer that begins in the lining of the uterus. The study will test a medication called dostarlimab, which is given through an intravenous infusion (delivered directly into a vein).

The purpose of this research is to evaluate how well dostarlimab works when given before surgery (as neoadjuvant therapy) in treating this specific type of endometrial cancer. During the study, participants will receive dostarlimab infusions, with each dose being 500 mg. The treatment may continue for up to 66 weeks, with regular medical check-ups to monitor the patient’s condition.

Throughout the study, doctors will use various imaging tests such as MRI, CT scan, and PET scan to check how the cancer responds to treatment. They will also perform physical examinations and monitor for any side effects. The total amount of dostarlimab that a patient might receive during the entire study period could reach up to 12,000 mg.

1 Initial evaluation

Your eligibility for the trial will be confirmed through medical tests and examinations

A tissue sample will be analyzed by a central laboratory to confirm MMRd status

Basic health parameters will be checked, including blood tests, liver function, and kidney function

2 Treatment phase – Dostarlimab administration

JEMPERLI (dostarlimab) 500 mg will be administered through an intravenous infusion

The treatment is given before any surgery (neoadjuvant therapy)

Regular monitoring of your health status will occur during the treatment period

3 Response evaluation

Your response to treatment will be evaluated using several imaging methods:

– Magnetic Resonance Imaging (MRI)

– Computed Tomography (CT) scan

– PET scan

A physical examination will also be performed

4 Treatment outcome assessment

The medical team will determine if the cancer has completely responded to treatment

Based on the evaluation results, a decision will be made regarding the need for surgery

If surgery is performed, the removed tissue will be examined to confirm the treatment’s effectiveness

5 Follow-up period

Regular check-ups will continue to monitor your health status

Any side effects will be recorded and managed according to standard guidelines

The follow-up period will include regular assessments to check for any signs of cancer recurrence

Who Can Join the Study?

Must be a female aged 18 years or older
Must be able to understand study procedures and provide written consent to participate
Must have a newly diagnosed endometrial cancer (specifically endometrioid type) confirmed by laboratory tests
Must have MMRd status (a specific genetic characteristic of the tumor) confirmed by laboratory testing
Must be able to provide adequate tumor tissue sample for testing
Must have stage II or III disease (cancer that has not spread beyond the pelvic area)
Must have good physical functioning ability (ECOG status of 0 or 1, meaning able to perform daily activities)
Must not have received any previous cancer treatments, including radiation or hormone therapy
Must have adequate organ function as shown by blood tests, including:
- Adequate blood cell counts
- Normal liver function
- Adequate kidney function
- Normal blood clotting tests
If of childbearing potential, must:
- Use highly effective contraception during the study and for 120 days after
- Not be pregnant or breastfeeding
- Agree not to donate eggs during this period

Who Cannot Join the Study?

Male patients (study is only for female participants)
Patients younger than 18 years old
Patients who do not have confirmed MMRd/MSI-H endometrial cancer (a specific type of uterine cancer with certain genetic characteristics)
Patients with cancer stages other than stage II-III
Patients who belong to vulnerable populations (such as persons with mental disabilities, prisoners, or others unable to give informed consent)
Patients who cannot provide informed consent for participation
Patients who are currently participating in other clinical trials
Patients who are pregnant or breastfeeding
Patients with severe allergic reactions to similar medications in the past
Patients with uncontrolled medical conditions that could interfere with the study treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ifgfhvnn Cmeddh Dlazictcqcpcqsbyc	L'hospitalet De Llobregat	Spain
Hxutkaxp Umzhxjjkjbeny dk A Ckyofq	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Dostarlimab

Dostarlimab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, dostarlimab helps your immune system recognize and destroy cancer cells, particularly in endometrial cancer. This medication is given through an intravenous (IV) infusion, which means it’s delivered directly into your bloodstream through a vein.

Investigated diseases:

Endometrial Cancer with MMRd/MSI-H – A specific type of cancer that begins in the lining of the uterus (endometrium) characterized by DNA mismatch repair deficiency (MMRd) or high levels of microsatellite instability (MSI-H). This form of endometrial cancer shows specific genetic changes that affect how DNA repairs itself. The condition specifically refers to stage II-III disease, meaning the cancer has grown beyond the uterus but remains confined to the pelvic region. The cancer develops when cells in the endometrium begin to grow out of control due to these specific genetic alterations. These genetic characteristics (MMRd/MSI-H) make the tumor cells grow and divide in a particular way that distinguishes them from other types of endometrial cancer.

Trial ID:

2024-512021-81-00

Protocol code:

GEICO 137-E

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of dostarlimab treatment before surgery in patients with stage II-III endometrial cancer with specific genetic markers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?