Study Comparing Pembrolizumab and Chemotherapy for Patients with Advanced or Recurrent 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 is comparing the effectiveness of a medication called pembrolizumab (also known by its code name MK-3475) against a group of chemotherapy drugs known as platinum doublet chemotherapy. The chemotherapy drugs being used in this study include cisplatin, paclitaxel, carboplatin, and docetaxel. 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 how well pembrolizumab works compared to the chemotherapy drugs in treating patients with a specific type of endometrial cancer that is advanced or has come back after treatment. This type of cancer is known as mismatch repair deficient (dMMR) endometrial carcinoma. The study will involve participants receiving either pembrolizumab or the chemotherapy drugs, and their progress will be monitored over time to see which treatment is more effective in controlling the cancer.

Participants in the study will receive treatment for a period of up to 24 months. During this time, doctors will regularly check the size of the cancer and the overall health of the participants to determine how well the treatments are working. The study aims to provide valuable information on which treatment option might be better for patients with this type of endometrial cancer, potentially leading to improved treatment strategies in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication pembrolizumab, and the other group will receive a combination of chemotherapy drugs. This process is called randomization and ensures that the study results are unbiased.

2 treatment with pembrolizumab

If assigned to the pembrolizumab group, you will receive this medication through an intravenous infusion. This means the medication is given directly into your vein using a needle. The dosage is 25 mg/mL, and the frequency and duration of administration will be determined by the study team based on your specific needs and the study protocol.

3 treatment with chemotherapy

If assigned to the chemotherapy group, you will receive a combination of drugs, which may include cisplatin, paclitaxel, carboplatin, or docetaxel. These medications are also administered intravenously. The specific drugs, their dosages, and the frequency of administration will be determined by the study team.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effectiveness of the treatment. This may include physical exams, blood tests, imaging tests, and questionnaires about your quality of life.

5 end of treatment

At the end of the treatment period, you will undergo final assessments to determine the overall impact of the treatment on your condition. This will help the study team understand the effectiveness and safety of the treatments being tested.

6 follow-up

After completing the treatment, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment. These visits are important for gathering information about the long-term benefits and risks of the treatments.

Who Can Join the Study?

Must have a confirmed diagnosis of inoperable, Stage III or IV, or recurrent Endometrial Carcinoma (a type of cancer that starts in the lining of the uterus) or carcinosarcoma (a rare type of cancer that contains two types of cells) that is confirmed as dMMR (a specific genetic feature of the cancer).
Must have disease that can be seen on imaging tests, either measurable or non-measurable, as assessed by the doctor. If the cancer was surgically removed at Stage IVB, participation is allowed regardless of measurable disease.
Must not have received prior systemic therapy for endometrial cancer, except:
- May have had one prior line of platinum-based chemotherapy if the cancer returned at least 6 months after the last dose.
- May have had prior radiation therapy if it was completed more than 2 weeks before starting the study treatment. Must have recovered from any side effects of radiation and not need steroids.
- May have had prior hormonal therapy if it was stopped at least 1 week before starting the study.
Must have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work, within 7 days before starting the study.
Must not be pregnant or breastfeeding and must agree to use a highly effective birth control method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if of childbearing potential.
Must have a negative pregnancy test within 24 hours (for urine) or 72 hours (for blood) before the first dose of study treatment if of childbearing potential.
Must provide a sample of tumor tissue for verification of dMMR status and cancer type.
If positive for Hepatitis B, must have received antiviral therapy for at least 4 weeks and have an undetectable viral load before starting the study.
If has a history of Hepatitis C, must have an undetectable viral load at screening.
Must be female, as the study does not include male participants.

Who Cannot Join the Study?

Patients who are not diagnosed with endometrial cancer cannot participate.
Only female patients are eligible for this study.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients with active infections that require treatment cannot participate.
Patients with other cancers that are not endometrial cancer cannot participate.
Patients who have received another experimental treatment within a certain time frame cannot participate.
Patients with uncontrolled medical conditions that could interfere with the study cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Kuopio University Hospital	Kuopio	Finland
Hospital Universitario De Navarra	Pamplona	Spain
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
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
Helse Stavanger HF	Stavanger	Norway
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Grand Hopital De Charleroi	Charleroi	Belgium
Bon Secours Hospital Cork	Cork	Ireland
Fakultni Nemocnice Bulovka	Prague	Czechia
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
Szpital Kliniczny Im. Ks. Anny Mazowieckiej samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Fakultni Nemocnice Brno	Brno	Czechia
Karolinska University Hospital	Solna	Sweden
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Aalborg University Hospital	Aalborg	Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Rigshospitalet	Copenhagen	Denmark
Pirkanmaan hyvinvointialue	Tampere	Finland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Region Sjaelland	Holbæk	Denmark
University Hospital Ostrava	Ostrava	Czechia
Inlfoc Iqhamaox Fqcqcymmjigbr Owtdmbgdebr	Rome	Italy
Lzwwi Uluoqddlxeue Mhqqbcr Ctnjoiw (bmdwa	Leiden	The Netherlands
Uwlborvpcpze Mdccazt Cthelsl Gejinlfdm	Groningen	The Netherlands
Idrwqoqv Csmqmf Dtylgrakbbirdyhzt	L'hospitalet De Llobregat	Spain
Hlwfnd Hgedgrkk	Herlev	Denmark
Irjackaf Rstbrsjvw Plw Lt Shfyal Dco Tlukda Dkbv Anivtoa Iqtl Sgqgzx	Meldola	Italy
Auhytpatd Unv	Amsterdam	The Netherlands
Hzfsyrux Ugsrcnicky Cihfbde Hsawqtff	Helsinki	Finland
Ecyhvlm Uisthrqunfmh Mlyxunu Cbarvop Rjyrgcaew (fbwdumr Mki	Rotterdam	The Netherlands
Nlrxgwhw Iktxeqtx Ogcnfxdym Ity Mfuff Skuqvrsnhqkyrtitjkhexpurkfmi Iwtdkiik Bhxqldij	Cracow	Poland
Abgneuf Ubcqa Smcoppoto Lhxvgj Dm Bdmnzzi	Bologna	Italy
Hbksrrlz Vmvn djkopjpw	Barcelona	Spain
Hrfkllaq Umibwmyaoepwk dc A Catgpo	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2022
Czechia	Not recruiting	01.04.2022
Denmark	Not recruiting	01.04.2022
Finland	Not recruiting	01.04.2022
Germany	Not recruiting	01.04.2022
Hungary	Not recruiting	01.04.2022
Ireland	Not recruiting	01.04.2022
Italy	Not recruiting	01.04.2022
Norway	Not recruiting	01.04.2022
Poland	Not recruiting	01.04.2022
Spain	Not recruiting	01.04.2022
Sweden	Not recruiting	01.04.2022
The Netherlands	Not recruiting	01.04.2022

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help people with a specific type of endometrial cancer that has certain genetic features. The goal is to find out if pembrolizumab can help stop the cancer from growing or spreading and if it can help patients live longer.

Platinum Doublet Chemotherapy is a combination of two chemotherapy drugs that are often used together to treat cancer. These drugs work by killing cancer cells or stopping them from growing. In this trial, the combination is used as a standard treatment to compare against pembrolizumab. The aim is to see which treatment is more effective in controlling the cancer and improving survival in patients with advanced or recurrent endometrial cancer.

Endometrial cancer – Endometrial cancer 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. The disease often progresses slowly, initially causing symptoms such as abnormal vaginal bleeding or discharge. As it advances, the cancer may invade nearby tissues and organs, such as the cervix or bladder. In some cases, it can spread to distant parts of the body through the lymphatic system or bloodstream. The progression of endometrial cancer can vary, with some cases remaining localized while others become more widespread.

Trial ID:

2023-506361-56-00

Protocol code:

MK-3475-C93

NCT ID:

NCT05173987

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Pembrolizumab and Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?