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

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What is this study about?

This clinical trial is focused on studying treatments for endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study involves patients with recurrent or primary advanced stages of this cancer. The main treatment being tested is a medication called Dostarlimab, also known by its code name TSR-042. Dostarlimab is a type of drug known as a monoclonal antibody, which is designed to help the immune system fight cancer cells. In this study, Dostarlimab is combined with two chemotherapy drugs, Carboplatin and Paclitaxel, and compared to a combination of a placebo with Carboplatin and Paclitaxel. Additionally, another medication called Niraparib is being tested in combination with Dostarlimab in some parts of the study.

The purpose of the study is to determine if adding Dostarlimab to the standard chemotherapy treatment can delay the return of cancer or improve survival rates in patients with advanced endometrial cancer. The study is divided into two parts. In the first part, patients receive either Dostarlimab with chemotherapy or a placebo with chemotherapy. In the second part, some patients receive Dostarlimab with Niraparib and chemotherapy, while others receive a placebo with chemotherapy. The study is designed to be double-blind, meaning neither the patients nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

Participants in the study will receive treatment over a period of time and will be monitored regularly to assess the progression of their cancer and overall health. The study aims to provide valuable information on the effectiveness of Dostarlimab and Niraparib in treating advanced endometrial cancer, potentially leading to improved treatment options for patients in the future.

1 Joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving the study treatment or a placebo.

2 Initial treatment phase

The patient will receive a combination of medications. This includes dostarlimab administered through an intravenous infusion, and two chemotherapy drugs, carboplatin and paclitaxel. The exact dosage and frequency will be determined by the study protocol and the patient’s specific condition.

3 Continuation of treatment

After the initial phase, the patient will continue to receive dostarlimab or a placebo, depending on the group they were assigned to. This phase aims to maintain the treatment’s effects and monitor the patient’s response.

4 Additional treatment phase (Part 2 only)

In Part 2 of the study, some patients will receive an additional medication called niraparib, which is taken orally. This phase is designed to evaluate the combined effect of dostarlimab and niraparib on the patient’s condition.

5 Monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular medical assessments, imaging tests, and laboratory evaluations to track the progression of the disease and any side effects of the treatment.

6 Completion of the study

The study is expected to conclude by November 2026. At the end of the study, the patient’s overall health and treatment outcomes will be evaluated to determine the effectiveness of the treatment regimen.

Who Can Join the Study?

  • The participant must be a female who is at least 18 years old and can understand the study procedures. She must agree to participate by signing a written consent form.
  • The participant must have endometrial cancer that has been confirmed through tests. The cancer should be either recurring or advanced.
  • The participant must provide a sample of their tumor tissue for testing during the screening process. This sample will be used to check specific characteristics of the cancer. The quality of the sample must be confirmed by a central laboratory before the participant can be included in the study.
  • The participant must have either primary Stage III or Stage IV endometrial cancer or a first recurrence of the cancer. The cancer should have a low chance of being cured by radiation or surgery alone. The participant must meet at least one of the following conditions:
    • Has primary Stage IIIA to IIIC1 disease with measurable or visible disease based on specific criteria. If there are any unclear areas, they should be tested to confirm the presence of a tumor.
    • Has primary Stage IIIC1 disease with specific types of cancer cells, regardless of measurable disease on imaging.
    • Has primary Stage IIIC2 or Stage IV disease, regardless of measurable disease.
    • Has a first recurrence of the disease and has not received systemic anticancer therapy before.
    • Has received prior anticancer therapy before surgery and had a recurrence or disease progression at least 6 months after completing treatment.

    Note: Participants with uterine sarcoma are not allowed.

  • The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
  • The participant must have adequate organ function, which includes:
    • A certain level of white blood cells called neutrophils.
    • A certain number of platelets, which help with blood clotting.
    • A certain level of hemoglobin, which carries oxygen in the blood.
    • A certain level of creatinine, which indicates kidney function, or a calculated creatinine clearance level.
    • A certain level of bilirubin, which is a substance made by the liver.
    • Certain levels of liver enzymes, which are proteins that help the liver function.
    • Certain levels of blood clotting times, which measure how well the blood clots.
  • The participant must use contraception that is highly effective if they are of childbearing potential. They must not be pregnant or breastfeeding and must agree not to donate eggs during the study and for a certain period after the last dose of study treatment. A negative pregnancy test is required before starting the study treatment.
  • For Part 2 only: The participant must have normal blood pressure or controlled high blood pressure.
  • For Part 2 only: The participant must be able to take medication by mouth.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than endometrial cancer. Endometrial cancer is a type of cancer that starts in the lining of the uterus.
  • Patients who are not in Stage III or IV of endometrial cancer. These stages indicate advanced cancer that has spread beyond the uterus.
  • Patients who are male, as the study is only for female patients.
  • Patients who are not considered part of a vulnerable population. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as those with limited ability to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Orszagos Onkologiai Intezet Budapest Hungary
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Universitario 12 De Octubre Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Hochtaunus-Kliniken gGmbH Bad Homburg Germany
Ospedale Di Sassuolo S.p.A. Sassuolo Italy
University Of Debrecen Debrecen Hungary
Odense University Hospital Odense Denmark
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Fakultni Nemocnice Brno Brno Czechia
Karolinska University Hospital Solna Sweden
Turku University Hospital Turku Finland
Aalborg University Hospital Aalborg Denmark
Hospital Universitario Virgen De Valme Sevilla Spain
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rigshospitalet Copenhagen Denmark
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Region Sjaelland Holbæk Denmark
Hospital Universitario Virgen De La Victoria Malaga Spain
Iuujbd Ipbanpwe Fokqbbmnwzlyr Oygalkqkwnx Rome Italy
Oofudqnjbpbpldfsewkodffecs Aalst Belgium
Urvtsfdeyxrhi Slszqao Kxyitdiox Nb 2 Pqj W Sybtitoqwu Szczecin Poland
Hhqfzl Hvoajtae Herlev Denmark
Akwafewgq Uhq Amsterdam The Netherlands
Uydiuew Utabqcluao Hmlgtcgl Uppsala Sweden
Hxsur Bwgsxv Hz Bergen Norway
Eipbeyu Uvwevhryhvwy Mlcxvaj Cunyduo Rztkwtihh (jhzvobr Mvq Rotterdam The Netherlands
Htbdpdwh Upiygfiuptaqq Drgmnmnt Donostia / San Sebastian Spain
Hiimoioy Vpmn dqqwdndm Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
18.07.2019
Czechia Czechia
Not recruiting
18.07.2019
Denmark Denmark
Not recruiting
18.07.2019
Finland Finland
Not recruiting
18.07.2019
Germany Germany
Not recruiting
18.07.2019
Greece Greece
Not recruiting
18.07.2019
Hungary Hungary
Not recruiting
18.07.2019
Italy Italy
Not recruiting
18.07.2019
Norway Norway
Not recruiting
18.07.2019
Poland Poland
Not recruiting
18.07.2019
Spain Spain
Not recruiting
18.07.2019
Sweden Sweden
Not recruiting
18.07.2019
The Netherlands The Netherlands
Not recruiting
18.07.2019

Trial locations

Investigated drugs:

Dostarlimab (TSR-042) is an investigational medication used in this trial to treat patients with recurrent or primary advanced endometrial cancer. It is designed to help the immune system recognize and attack cancer cells more effectively. In this study, it is used in combination with other cancer treatments to evaluate its effectiveness in improving patient outcomes.

Carboplatin is a chemotherapy drug used in this trial to treat endometrial cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. Carboplatin is commonly used in combination with other chemotherapy drugs to enhance its effectiveness.

Paclitaxel is another chemotherapy medication used in this study. It helps stop the growth of cancer cells by inhibiting their ability to divide. Paclitaxel is often used alongside other chemotherapy agents to treat various types of cancer, including endometrial cancer.

Niraparib is a medication included in the second part of the trial. It is a type of targeted therapy known as a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, leading to cell death. Niraparib is used in combination with other treatments to assess its potential benefits in improving the survival of patients with 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 can be classified into different stages, with Stage III and IV indicating advanced cancer that may have spread beyond the uterus. Symptoms often include abnormal vaginal bleeding, pelvic pain, and weight loss. The progression of endometrial cancer can vary, with some cases growing slowly while others may spread more rapidly. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:
2023-506551-23-00
Protocol code:
4010-03-001
NCT ID:
NCT03981796
Trial Phase:
Therapeutic confirmatory (Phase III)

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