Study on Durvalumab, Paclitaxel, Carboplatin, and Olaparib 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 occurs in the lining of the uterus or womb. The study involves a combination of medications, including Durvalumab and Olaparib. Durvalumab, also known by its code name MEDI4736, is a medication given through an infusion into the vein. Olaparib, also known by its code name AZD2281, is taken orally in the form of film-coated tablets. The purpose of the study is to evaluate the effectiveness and safety of these medications when used together with standard chemotherapy drugs, Paclitaxel and Carboplatin, in patients who have newly diagnosed advanced or recurrent endometrial cancer.

Participants in the study will receive a combination of these treatments. Initially, they will be given Paclitaxel and Carboplatin along with Durvalumab. After this initial phase, some participants will continue to receive Durvalumab alone, while others will receive Durvalumab in combination with Olaparib. The study is designed to compare these different treatment approaches to see which is most effective in preventing the cancer from progressing.

The study will be conducted over a period of time, with regular monitoring to assess the health and response of the participants to the treatments. The goal is to determine how well these treatments work in extending the time patients live without their cancer getting worse and to evaluate the overall safety of the treatment combinations. Participants will be closely observed for any side effects or changes in their condition throughout the study.

1 initial treatment phase

The initial treatment phase involves the administration of chemotherapy drugs, specifically carboplatin and paclitaxel. These medications are used to treat endometrial cancer, which affects the lining of the uterus.

During this phase, the chemotherapy drugs are given to the patient to help reduce the size of the cancer and prevent it from spreading further.

2 combination therapy with durvalumab

Following the initial chemotherapy, the patient receives durvalumab, a medication administered through an intravenous infusion. This is a type of immunotherapy that helps the immune system recognize and attack cancer cells.

Durvalumab is given in combination with the chemotherapy drugs to enhance the treatment’s effectiveness.

3 maintenance therapy

After the combination therapy, the patient enters the maintenance phase. In this phase, durvalumab is continued to help maintain the response achieved with the initial treatments.

Depending on the specific treatment arm, the patient may also receive olaparib, which is taken orally in the form of film-coated tablets. Olaparib is used to further support the treatment by targeting cancer cells at a molecular level.

4 monitoring and follow-up

Throughout the trial, the patient’s health and response to the treatment are closely monitored. This includes regular check-ups, imaging tests, and laboratory assessments to evaluate the effectiveness of the treatment and to detect any potential side effects.

The trial aims to assess various outcomes, such as progression-free survival, overall survival, and the duration of response to the treatment.

Who Can Join the Study?

Must be a female who is at least 18 years old at the time of screening.
Must have a confirmed diagnosis of epithelial endometrial carcinoma. This includes all types of this cancer, except for sarcomas.
Must have endometrial cancer in one of these categories:
- Newly diagnosed Stage III disease with measurable disease after surgery or a biopsy.
- Newly diagnosed Stage IV disease, with or without disease after surgery or a biopsy.
- Recurrent disease, which means the cancer has come back, and it is either measurable or not measurable, where surgery alone or with other treatments is unlikely to cure it.
Must not have received any first-line systemic anti-cancer treatment. If the patient has recurrent disease, previous treatment is allowed only if it was given as part of the initial treatment and at least 12 months have passed since the last dose of chemotherapy before the cancer returned.
A FFPE tumor sample must be available for MMR evaluation. FFPE stands for formalin-fixed, paraffin-embedded, which is a way of preserving tissue samples. MMR evaluation checks for certain genetic features of the tumor.
Must have an ECOG performance status of 0 or 1 within 7 days of starting the study treatment. This is a scale used to assess how well a patient can perform daily activities, where 0 means fully active and 1 means some restrictions but still able to do light work.

Who Cannot Join the Study?

Patients who are not diagnosed with endometrial cancer cannot participate. Endometrial cancer is a type of cancer that begins in the lining of the uterus.
Only female patients are eligible, so male patients cannot participate.
Patients who are not newly diagnosed with advanced or recurrent endometrial cancer are excluded.
Patients who are not considered part of a vulnerable population are excluded. A vulnerable population may include individuals who are at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Universitario De Jaen	Jaen	Spain
Hopital De Libramont	Libramont-Chevigny	Belgium
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Alexandra Hospital	Athens	Greece
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Tartu University Hospital	Tartu	Estonia
Klinikum Chemnitz gGmbH	Chemnitz	Germany
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
CHC MontLegia	Liege	Belgium
Budapesti Uzsoki Utcai Korhaz	Budapest	Hungary
Cznhupibd Ulgrfsmnikjxei Swtbcrnkg	Woluwe-Saint-Lambert	Belgium
Uawo Cjnxrtta Tojorj Sai z omck	Lodz	Poland
Wsunlqonomc Wjsyealclyhmrwyzqlku Coqbxyk Ookcsusaa I Tthuhzhcmylgp Im Mwizjcyotcw W Lzviq	Lodz	Poland
Pygr Ttenu Harxfmod Uowdpayjfode	Sabadell	Spain
Gugjqgrffwxdcooai Vdulpycpp Prbg Afabfz Edakozaa Ozpcht Kaacvc	Gyor	Hungary
Acfmlqg Hvmaksfp	Athens	Greece
Uilbigssliuahw Chpkjxo Klylfpyog	Gdansk	Poland
Ioplpvtx Cyvwli Dsiwwuutlcgqgnsxj	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.03.2020
Estonia	Not recruiting	02.03.2020
Germany	Not recruiting	02.03.2020
Greece	Not recruiting	02.03.2020
Hungary	Not recruiting	02.03.2020
Lithuania	Not recruiting	02.03.2020
Poland	Not recruiting	02.03.2020
Spain	Not recruiting	02.03.2020

Trial locations

Investigated drugs:

Carboplatin is a chemotherapy medication used to treat various types of cancer. In this trial, it is used as part of the initial treatment to help stop the growth of cancer cells in patients with advanced or recurrent endometrial cancer.

Paclitaxel is another chemotherapy drug that works by stopping cancer cells from dividing and growing. It is used in combination with carboplatin to enhance the effectiveness of the treatment in the initial phase of the trial.

Durvalumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. In this trial, it is used both in combination with chemotherapy and as a maintenance therapy to help prevent the cancer from returning or progressing.

Olaparib is a targeted therapy that works by interfering with the cancer cells’ ability to repair their DNA, leading to cell death. In this trial, it is used in combination with durvalumab during the maintenance phase to potentially improve outcomes for patients.

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 after menopause, but it can occur in younger women as well. The disease often presents with symptoms such as abnormal vaginal bleeding or discharge, pelvic pain, and weight loss. As the cancer progresses, it may invade the muscular layer of the uterus and spread to nearby organs or lymph nodes. In advanced stages, it can metastasize to distant parts of the body, such as the lungs or liver. Early detection and monitoring of symptoms are crucial for managing the progression of this disease.

Trial ID:

2022-502746-27-00

Protocol code:

D9311C00001

NCT ID:

NCT04269200

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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