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Study on Durvalumab, Olaparib, and Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer in Spain

3 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study is specifically looking at cases where the cancer is advanced or has returned after treatment. The treatment being tested involves a combination of medications. The first medication is durvalumab, also known by its code name MEDI4736, which is given as an infusion. An infusion is a way of delivering medication directly into the bloodstream through a vein. The second medication is olaparib, which is taken as a tablet by mouth. These medications are used together with a type of chemotherapy that contains platinum, a metal used in some cancer treatments.

The purpose of the study is to understand the safety of using durvalumab with platinum-based chemotherapy, followed by durvalumab and olaparib as a first treatment option for patients with this type of cancer. The study will follow a specific course where patients will first receive the combination of durvalumab and chemotherapy. After this initial phase, patients will continue with durvalumab and olaparib. Some patients may receive a placebo instead of the active medications to help compare the effects.

Throughout the study, the health and progress of the participants will be closely monitored to gather information on how the treatment affects them. This includes looking at any side effects and how well the cancer responds to the treatment. The study aims to provide valuable insights into the potential benefits and risks of this treatment approach for endometrial cancer.

1 initial treatment phase

The treatment begins with the administration of durvalumab in combination with platinum-based chemotherapy. Durvalumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein.

This phase is designed to target and treat advanced or recurrent endometrial cancer. The specific schedule and duration of this phase will be determined by the healthcare provider based on individual patient needs and response to treatment.

2 maintenance treatment phase

Following the initial treatment phase, the patient will continue with durvalumab in combination with olaparib. Olaparib is taken orally in the form of film-coated tablets.

The dosage of olaparib will be either 100 mg or 150 mg, as prescribed by the healthcare provider. The frequency and duration of this maintenance phase will be tailored to the patient’s response and overall health condition.

3 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess the patient’s response to the treatment and to identify any potential side effects. This includes routine medical examinations and possibly imaging tests.

The healthcare team will evaluate the safety and effectiveness of the treatment, adjusting the regimen as necessary to ensure the best possible outcomes for the patient.

4 end of treatment evaluation

At the conclusion of the treatment period, a comprehensive evaluation will be performed to determine the overall impact of the therapy on the patient’s cancer.

This evaluation will include a review of the patient’s health status, any changes in the cancer’s progression, and the patient’s quality of life throughout the trial.

Who Can Join the Study?

  • Women who are 18 years or older at the time of screening.
  • Must have adequate organ and bone marrow function. This means:
    • Hemoglobin level of at least 10.0 g/dL.
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L.
    • Platelet count of at least 100 x 109/L.
    • Serum bilirubin level no more than 1.5 times the upper limit of normal, except for patients with Gilbert’s syndrome.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 2.5 times the upper limit of normal, or 5 times for patients with liver metastases.
  • Creatinine clearance (a measure of kidney function) must be greater than 51 mL/min, determined by a specific calculation or test.
  • Must provide an informed consent form, which includes agreeing to participate in biomarker research.
  • Must have a confirmed diagnosis of endometrial carcinoma (a type of cancer), with a biopsy sample available.
  • Only patients with pMMR tumors (a specific tumor characteristic) are allowed.
  • Must have endometrial cancer in one of these categories:
    • Newly diagnosed Stage III disease with measurable disease after surgery or biopsy.
    • Newly diagnosed Stage IV disease, even if no disease remains after surgery.
    • Recurrent disease where surgery alone is unlikely to cure.
  • Must not have received first-line systemic anti-cancer treatment. If they have recurrent disease, previous treatment is allowed only if it was given after surgery and at least 6 months have passed since the last treatment.
  • Must have at least one, preferably two, tumor sample blocks available for testing. These samples should have a certain amount of tumor cells and size.
  • Must have an ECOG/WHO performance status of 2 or less, which is a measure of daily living abilities. No more than 20% of patients can have a status of 2.
  • Must be postmenopausal or have evidence of not being able to have children. This includes a negative pregnancy test before starting treatment. Women are considered postmenopausal if they have not had a period for 12 months without another medical reason, or if they have had certain surgeries or treatments.

Who Cannot Join the Study?

  • Patients with other types of cancer besides advanced or recurrent endometrial cancer cannot participate.
  • Patients who have previously received treatment with the same drugs being tested in the study are not eligible.
  • Patients with serious health conditions that could interfere with the study treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with known allergies to the study drugs are not eligible.
  • Patients who are unable to follow the study procedures or attend study visits are excluded.
  • Patients with certain infections or diseases that could affect the study results are not eligible.
  • Patients who are participating in another clinical trial at the same time are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario De Cruces Barakaldo Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Alvaro Cunqueiro Vigo Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Hqnqddym Uqghrprscages Mhiedrs Dh Vzbyjwunbt Santander Spain
Ivcknxuk Cnzxzl Dvxloazasdcduxltw L'hospitalet De Llobregat Spain
Hjuefdbp Uzuvynbuhxfad Dxickrhn Donostia / San Sebastian Spain
Fakvqudhe Pntz Lf Iearrfrrhliqb Brmabidwv Dwe Hpykpkvy Ujixhcmygouph Ln Pcg Madrid Spain
Haixybkt Vnsk ddsmlxzb Barcelona Spain
Hcaubhol Uyphfdpzhvwhe dl A Cpexvr A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.11.2024

Trial locations

Investigated drugs:

Durvalumab is a medication used to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this trial, it is used in combination with other treatments to help treat advanced or recurrent endometrial cancer.

Platinum-based Chemotherapy refers to a group of cancer treatments that contain the metal platinum. These medications work by damaging the DNA of cancer cells, which prevents them from growing and dividing. In this trial, platinum-based chemotherapy is used alongside durvalumab to treat endometrial cancer.

Olaparib is a medication that targets cancer cells by interfering with their ability to repair damaged DNA. This can lead to the death of cancer cells. In this trial, olaparib is used after initial treatment with durvalumab and platinum-based chemotherapy to continue fighting endometrial cancer.

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 often presents with symptoms such as abnormal vaginal bleeding or discharge. As it progresses, the cancer can invade the muscular layer of the uterus and spread to nearby organs. In advanced stages, it may metastasize to distant parts of the body, including the lungs and liver. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.

Trial ID:
2024-514728-17-00
Protocol code:
D9311L00001
Trial Phase:
Human Pharmacology (Phase I) – Other

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