Study of Durvalumab and Tremelimumab for Patients with Colorectal and Endometrial Cancer

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What is this study about?

This clinical trial is focused on studying two types of cancer: colorectal cancer and endometrial cancer. These cancers are being examined in two specific forms: microsatellite stable (MSS) and microsatellite instable (MSI). The study is testing the effects of two medications, Durvalumab and Tremelimumab. Durvalumab is also known by its code name MEDI4736, and Tremelimumab is sometimes referred to as CP-675,206 or MEDI1123. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well these medications work in treating the specified types of cancer. Participants in the study will receive either Durvalumab alone or a combination of Tremelimumab followed by Durvalumab. The study will observe how the cancer responds to these treatments over time. The trial will also look at the safety of the medications and any side effects that may occur. The study will involve regular visits to the clinic for treatment and monitoring, but specific details about the schedule are not provided here.

Throughout the study, researchers will also analyze the cancer cells at a very detailed level, known as single-cell profiling, to understand how they react to the treatment. This analysis will help identify any changes in the cancer cells and may provide insights into why some cells persist despite treatment. The study aims to gather information that could improve future cancer treatments and help understand the role of certain biomarkers, which are substances in the body that can indicate how well the treatment is working.

1 initial visit and consent

Upon joining the study, you will have an initial visit where you will be asked to provide signed informed consent. This consent confirms your understanding of the study and your agreement to participate. It includes compliance with the requirements and restrictions outlined in the consent form.

2 screening and eligibility

During this phase, your eligibility for the study will be assessed. This includes confirming that you have at least one measurable tumor lesion suitable for biopsy and that you meet other health criteria such as age, weight, and organ function.

You will also need to confirm your willingness to use adequate contraception if applicable, and provide evidence of post-menopausal status or a negative pregnancy test if you are a female of childbearing potential.

3 treatment initiation

If eligible, you will begin treatment with durvalumab or a combination of durvalumab and tremelimumab. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

The dosage for tremelimumab is 300 mg as a single dose, followed by durvalumab. The specific schedule and duration of the treatment will be explained to you by the study team.

4 ongoing assessments

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to evaluate the response of your tumors to the treatment.

The study team will also assess any side effects you may experience and adjust your treatment as necessary.

5 end of treatment and follow-up

Once your treatment is complete, you will enter a follow-up phase. During this time, your health will continue to be monitored to assess the long-term effects of the treatment and your overall well-being.

The study team will provide you with a schedule for follow-up visits and any additional tests that may be required.

Who Can Join the Study?

Capable of giving signed informed consent, which means you understand the study and agree to participate.
Have at least one tumor that is at least 10 mm in size and can be biopsied, which means a small sample can be taken for testing.
Have at least one measurable tumor according to specific medical guidelines.
If you are a male or female who can have children, you must agree to use birth control during the study and for a certain period after the study ends. Abstinence is acceptable if it is your usual lifestyle.
Must be over 18 years old.
Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
For Cohort 1: Have colorectal or endometrial cancer that has come back or spread, and cannot be treated with surgery. The cancer must have specific genetic characteristics known as MSI-H or dMMR.
For Cohort 2: Have colorectal cancer that has come back or spread, cannot be treated with surgery, and has specific genetic characteristics known as MSS or pMMR. The cancer must have worsened after certain treatments, or you could not tolerate these treatments. If your cancer is EGFR positive/RAS wild type, you must have had prior treatment targeting EGFR. Or, have endometrial cancer that has worsened after specific treatments and cannot be treated with surgery, with known MSS or pMMR status.
Have a life expectancy of more than 12 weeks.
Weigh more than 30 kg (about 66 pounds).
Have normal organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function.
If you are a woman, you must either be post-menopausal or have a negative pregnancy test. Post-menopausal means you have not had a period for 12 months without another medical reason.
Willing and able to follow the study protocol, which includes attending treatment sessions, visits, and examinations.

Who Cannot Join the Study?

Patients with other types of cancer that are not microsatellite stable (MSS) or microsatellite instable (MSI) colorectal or endometrial tumors cannot participate. Microsatellite stable (MSS) and microsatellite instable (MSI) refer to specific genetic characteristics of the tumors.
Patients who have received other cancer treatments that might interfere with the study drugs cannot participate.
Patients with severe or uncontrolled medical conditions that could affect their safety or the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had an organ transplant cannot participate.
Patients with active infections, including HIV, hepatitis B, or hepatitis C, cannot participate.
Patients with a history of severe allergic reactions to similar drugs cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hawfgmem Vllh dfqeyzxd	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.03.2022

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, Durvalumab is being used to see how well it can help treat certain types of colorectal and endometrial cancers. The goal is to understand if it can help shrink the tumors or stop them from growing.

Tremelimumab is another immunotherapy medication. It also helps your immune system fight cancer by targeting specific cells that can prevent your immune system from working properly. In this trial, Tremelimumab is used in combination with Durvalumab to see if the two medications together can be more effective in treating certain types of colorectal and endometrial cancers. The researchers want to find out if this combination can improve the response to treatment in patients.

Investigated diseases:

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby. In advanced stages, the cancer may spread to other parts of the body, such as the liver or lungs. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others become more aggressive.

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, known as the endometrium. It typically develops when cells in the endometrium grow uncontrollably, forming a tumor. As the disease progresses, it can invade the muscular layer of the uterus and spread to other pelvic organs. In more advanced stages, it may metastasize to distant organs such as the lungs or liver. Common symptoms include abnormal vaginal bleeding, pelvic pain, and weight loss. The rate of progression can differ, with some tumors growing slowly and others advancing more rapidly.

Trial ID:

2023-509619-10-00

Protocol code:

ESR 21-21165

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab and Tremelimumab for Patients with Colorectal and Endometrial Cancer

What is this study about?

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