Study of Sacituzumab Tirumotecan and Pembrolizumab for Patients with Advanced or Recurrent Endometrial Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for endometrial cancer, specifically a type known as proficient mismatch repair (pMMR) endometrial carcinoma. The study is investigating the effectiveness and safety of a combination treatment using sacituzumab tirumotecan and pembrolizumab, compared to using pembrolizumab alone. Sacituzumab tirumotecan is a medication that targets cancer cells, while pembrolizumab is an immunotherapy drug that helps the immune system fight cancer.

The purpose of the study is to compare these treatments to see which is more effective in maintaining the health of participants with advanced or recurrent endometrial cancer. Participants will receive either the combination of sacituzumab tirumotecan and pembrolizumab or pembrolizumab alone. The study will monitor the participants’ health over time to assess the progression of the disease and overall survival rates.

Throughout the study, participants will be regularly evaluated to track their response to the treatment. This includes monitoring for any side effects and changes in their quality of life. The study aims to provide valuable information on the best treatment approach for individuals with this type of endometrial cancer.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Consent will be obtained to ensure understanding and agreement to participate.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination. Imaging tests may be conducted to evaluate the current state of the endometrial cancer.

3 randomization

Participants will be randomly assigned to one of two groups: one receiving sacituzumab tirumotecan in combination with pembrolizumab, and the other receiving pembrolizumab alone. This process ensures that the study results are unbiased.

4 treatment administration

Participants will receive their assigned treatment. Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein through a drip. The frequency and dosage will be determined by the study protocol and the healthcare team.

5 regular monitoring

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies. The healthcare team will assess the cancer’s response to the treatment and any side effects experienced.

6 completion of treatment

Once the treatment phase is completed, participants will undergo a final assessment. This will include a comprehensive evaluation of their health status and the effectiveness of the treatment.

7 follow-up

After completing the treatment, participants will enter a follow-up phase. This involves periodic visits to monitor long-term health outcomes and any delayed side effects. The follow-up period is crucial for gathering data on the treatment’s long-term efficacy and safety.

Who Can Join the Study?

  • Must have a confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that is proficient mismatch repair (pMMR). This means the cancer cells have a normal ability to repair DNA.
  • Must have disease that can be seen on imaging tests, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease. This is determined by a set of guidelines called Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
  • Must not have received any prior systemic therapy for endometrial carcinoma, except in specific cases: one prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy (treatments given before or after the main treatment to help improve outcomes) in a curative setting, prior radiation with or without chemotherapy that helps radiation work better if it was more than 2 weeks before starting the study treatment, or prior hormonal therapy for endometrial carcinoma that was stopped at least 1 week before starting the study treatment.
  • Must be female.
  • Must be within the age range specified by the study, which typically includes adults.

Who Cannot Join the Study?

  • Participants must not have any other type of cancer besides pMMR endometrial carcinoma. This is a specific type of cancer affecting the lining of the uterus.
  • Participants cannot be male. Only females are eligible for this study.
  • Participants must not be part of a vulnerable population. This means they should not be in a situation that makes them more at risk or unable to give informed consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Kuopio University Hospital Kuopio Finland
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Medical University Of Graz Graz Austria
University Hospital Maastricht Maastricht The Netherlands
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Universitetssykehuset Nord-Norge HF Tromsø Norway
Orszagos Onkologiai Intezet Budapest Hungary
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
CHU Saint Pierre Brussels Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Helse Stavanger HF Stavanger Norway
Az Maria Middelares Gent Gent Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Grand Hopital De Charleroi Charleroi Belgium
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
University Of Debrecen Debrecen Hungary
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Turku University Hospital Turku Finland
Universita’ Di Pisa Pisa Italy
Aalborg University Hospital Aalborg Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum Kassel GmbH Kassel Germany
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Hopital Prive Des Cotes D’armor Plerin France
St. Luke’s Hospital S.A. Thessaloniki Greece
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Pirkanmaan hyvinvointialue Tampere Finland
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut de Cancérologie de l’Ouest Saint-Herblain France
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Centre Francois Baclesse Caen France
Hygjccekz Mzstmabn Sxgrsz Milan Italy
Clelvp Ldjo Bguaoi Lyon France
Ihkpjj Ikceoljc Fcwwvsqfrfbuv Ozjlsangffz Rome Italy
Chfz Ubdjdilfvy Hrhazfan Cork Ireland
Iiozayxi Cecmge Dbsjzvlibqumrsowi L'hospitalet De Llobregat Spain
Ivuk Gaypf Filothei Greece
Fehqcfis nlzhmfazk Mjxkm a Hkqdjol Prague Czechia
Htyoyr Hocjgzao Herlev Denmark
Immgvlry Rjsjrauwo Pbg Lq Sdvxue Dbi Ttxsra Dftt Aqhyojc Iouk Smajcw Meldola Italy
Ucdyrqz Utmyqcceds Huythzbx Uppsala Sweden
Awbhnsz Ofkrbsuqmey Pvy Lulhlzlqmffwjziji Cjmtdfyath Catania Italy
Bgimsjvk Udzprzrqiu Hsbrpjjt Cpphya Besançon France
Hqfjntcl Uqafdfqyef Cjsaccu Hrxubxbn Helsinki Finland
Awfnnzm Odjgjzokbwa Uznbhnmjtzvke Cryeijnoydbk Ddosq Szsdyr E Dhydk Swmiagy Dp Tyozew Turin Italy
Ugtdrmzgdmudvdkzfzlvw Mbdmhtvj Aec Munster Germany
Nggofytz Igqjhept Ogxotaivj Iln Myfhb Swutqmiflfsvulwwfemwhxsjwqwn Iqrdtdgg Btcbrbrg Cracow Poland
Agrbscx Hikgkfkr Athens Greece
Ulqklkqcdbdhcf Cfsknzo Kadhpfhgt Gdansk Poland
Sz Vhyljiohkbflgjl Uqsnlnvxne Httgxpje Dublin Ireland
Fmtlttocv Pqbr Lt Iyucnsagudlwu Bfydgcjgc Dvn Hqdequpw Usxvcvzeghdpj Lr Pkj Madrid Spain
Hamnrfqe Vwby dwtlzjav Barcelona Spain
Iclcjewy Pxxxocuabdlhpbt Cnfekl Cvsdjp Marseille France
Umcbvewzif Gtngsex Hxcyfjhe Aqrhpxj Athens Greece
Izsrmlex Cudik Paris France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.07.2025
Belgium Belgium
Recruiting
01.07.2025
Czechia Czechia
Recruiting
01.07.2025
Denmark Denmark
Recruiting
01.07.2025
Finland Finland
Recruiting
01.07.2025
France France
Recruiting
01.07.2025
Germany Germany
Recruiting
01.07.2025
Greece Greece
Recruiting
01.07.2025
Hungary Hungary
Recruiting
01.07.2025
Ireland Ireland
Recruiting
01.07.2025
Italy Italy
Recruiting
01.07.2025
Norway Norway
Recruiting
01.07.2025
Poland Poland
Recruiting
01.07.2025
Spain Spain
Recruiting
01.07.2025
Sweden Sweden
Recruiting
01.07.2025
The Netherlands The Netherlands
Recruiting
01.07.2025

Trial locations

Sacituzumab Tirumotecan is a type of treatment that combines a drug with an antibody. The antibody part helps the drug find and attach to cancer cells. Once attached, the drug part works to kill the cancer cells. This treatment is being tested to see if it can help people with a specific type of endometrial cancer, which is a cancer that starts in the lining of the uterus.

Pembrolizumab is a medication that helps the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. This medication is already used to treat various types of cancer, and in this study, it is being tested to see how well it works as a maintenance treatment for endometrial cancer when used alone or in combination with another drug.

Investigated diseases:

Endometrial Carcinoma – Endometrial carcinoma is a type of cancer that begins in the lining of the uterus, known as the endometrium. It typically starts when cells in the endometrium undergo changes and begin to grow uncontrollably, forming a tumor. As the disease progresses, the cancerous cells can invade nearby tissues and organs, such as the cervix and ovaries. In advanced stages, the cancer may spread to distant parts of the body, including the lymph nodes, lungs, and liver. The progression of endometrial carcinoma can vary, with some cases remaining localized for extended periods, while others may advance more rapidly. The disease is often associated with symptoms such as abnormal vaginal bleeding, pelvic pain, and changes in menstrual cycles.

Trial ID:
2024-519331-42-00
Protocol code:
MK-2870-033
Trial Phase:
Therapeutic confirmatory (Phase III)

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