Study of Durvalumab alone and in combination with Tremelimumab in children with advanced solid tumors and blood cancer

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What is this study about?

This clinical trial focuses on studying advanced solid tumors and blood cancer in children. The study uses two medications: durvalumab (also known as IMFINZI) and tremelimumab (also known as IMJUDO). Both medications are given through intravenous administration, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how safe these medications are when used alone or together in young patients, and to determine the most appropriate dose levels. The medications being tested belong to a group of drugs that help the body’s immune system fight cancer cells. During the study, some patients will receive durvalumab by itself, while others will receive a combination of durvalumab and tremelimumab.

The study involves children and young people under 18 years of age whose cancer has not responded to standard treatments or has come back after previous treatment. Throughout the study, doctors will monitor patients’ health through regular check-ups and medical tests to understand how well the treatment is working and to watch for any side effects.

1 Initial treatment phase

You will receive two medications through intravenous infusion (directly into a vein):

– Imjudo (tremelimumab) 20 mg/ml solution for infusion

– Imfinzi (durvalumab) 50 mg/ml solution for infusion

These medications will be administered every 4 weeks

2 Continuation phase

After the initial combined treatment, you will continue receiving only Imfinzi (durvalumab) as a single medication

The treatment will continue to be administered through intravenous infusion every 4 weeks

3 Monitoring during treatment

Throughout the treatment, regular assessments will include:

– Physical examinations

– Blood tests

– Heart monitoring (ECG – electrical recording of heart activity)

– Vital signs measurements

– Tumor response evaluation using imaging methods

4 Safety monitoring

Your blood will be tested to check:

– Medication levels in your body

– Immune system cell counts

– Development of antibodies against the medications

Any side effects or changes in your health will be monitored and recorded

Who Can Join the Study?

Must have confirmed cancer diagnosis that has not responded to standard treatments or has gotten worse, and no other standard treatment options are available
If possible, must provide a tumor sample taken less than 3 years before screening to test for PD-L1 (a protein that helps determine treatment effectiveness)
Must meet minimum performance status requirements:
- For children aged 1-15 years: Lansky play score of 50 or higher (measures how active and able to play a child is)
- For those 16 years and older: Karnofsky score of 50 or higher (measures ability to perform daily activities)
- Children under 1 year do not need to meet this requirement
Must have cancer that can be measured or evaluated using standard medical practices
Must not have previously received:
- Immune checkpoint inhibitors (medications that help immune system fight cancer)
- CAR-T therapy or other cellular therapies (treatments using modified immune cells)
- Other similar immune system treatments (except cancer vaccines)

Who Cannot Join the Study?

Active or prior documented autoimmune disease (a condition where the immune system attacks healthy cells) within the past 2 years
History of primary immunodeficiency (weakened immune system from birth)
History of organ transplant requiring ongoing immunosuppression
Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
Current or prior use of immunosuppressive medication within 14 days before the first dose
Receipt of live attenuated vaccine within 30 days before the first dose
Uncontrolled concurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Uncontrolled high blood pressure
- Unstable chest pain
History of another cancer within 3 years before study entry
Known history of previous serious allergic reactions to study drugs
Pregnant or breastfeeding women
Any condition that may interfere with the interpretation of study results

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hxecvjhk Vzyb dtukqbrq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	31.01.2019

Trial locations

Investigated drugs:

Durvalumab is a medication that helps the immune system fight cancer cells. It belongs to a group of drugs called immunotherapy medications. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body’s natural defenses to better recognize and attack the cancer.

Tremelimumab is also an immunotherapy medication that works with the body’s immune system to fight cancer. It helps activate immune cells called T-cells to recognize and destroy cancer cells. When combined with durvalumab, it may provide a stronger anti-cancer effect by targeting the immune system in two different ways.

The trial studies these medications both individually and in combination to treat children who have advanced solid tumors and blood cancers that have not responded well to other treatments.

Investigated diseases:

Neoplasm malignant

Advanced Solid Tumors – A condition where abnormal cells form solid masses or tumors that have spread beyond their original location to other parts of the body. These tumors can develop in various organs or tissues, such as the lungs, liver, bones, or brain. The disease progresses when cancer cells continue to grow and multiply, forming new tumors in different locations. Advanced solid tumors typically involve multiple sites in the body and represent a later stage of cancer development. The tumors can grow larger over time and may affect the function of surrounding tissues and organs.

Trial ID:

2023-510424-68-00

Protocol code:

D419EC00001

NCT ID:

NCT03837899

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Durvalumab alone and in combination with Tremelimumab in children with advanced solid tumors and blood cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?