Study of Durvalumab and Tremelimumab for Patients with Advanced Unresectable Urothelial Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Stage IV Urothelial Cancer, a type of cancer that affects the urinary system, including the bladder, ureters, and urethra. The study involves patients whose cancer cannot be removed by surgery and who have not yet received chemotherapy. The trial will test the effectiveness of a medication called MEDI4736, also known as durvalumab, both on its own and in combination with another medication called tremelimumab. These treatments will be compared to the standard chemotherapy treatments currently used for this type of cancer.

The purpose of the study is to determine how well these new treatments work in extending the life of patients with this advanced cancer. Participants in the study will receive either the new treatment or the standard chemotherapy. Some participants may receive a combination of MEDI4736 and tremelimumab, while others will receive MEDI4736 alone. The study will also include a group of patients who will receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the progress of their cancer. The study aims to provide valuable information on whether these new treatments can offer better outcomes for patients with Stage IV Urothelial Cancer compared to the current standard of care. The trial is expected to continue until the end of 2025, with recruitment starting in September 2024.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This assignment is done to compare different treatments for advanced urothelial cancer.

2 treatment with MEDI4736 monotherapy

If assigned to the MEDI4736 monotherapy group, the patient will receive durvalumab (also known as MEDI4736) as an intravenous infusion. The dosage and frequency will be determined by the study protocol.

3 treatment with MEDI4736 and tremelimumab combination

If assigned to the combination therapy group, the patient will receive both durvalumab and tremelimumab as intravenous infusions. The specific dosage and schedule will be outlined in the study protocol.

4 standard of care chemotherapy

If assigned to the standard of care chemotherapy group, the patient will receive chemotherapy drugs as per the standard treatment for advanced urothelial cancer. The exact drugs and schedule will be based on current medical guidelines.

5 monitoring and follow-up

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular medical check-ups, imaging tests, and laboratory tests to assess the effectiveness of the treatment and any side effects.

6 end of study participation

The study is expected to conclude by December 31, 2025. At the end of the study, the patient’s overall health and treatment outcomes will be evaluated. Further treatment options may be discussed based on the results.

Who Can Join the Study?

Must be at least 18 years old.
Must provide written informed consent, which is a document that explains the study and confirms your agreement to participate.
Must have a specific type of cancer called transitional cell carcinoma in the urinary system, which includes areas like the bladder and urethra. The cancer must be at an advanced stage (Stage IV) and cannot be removed by surgery.
Must not have received chemotherapy treatment for this cancer before.
Must have at least one tumor that can be measured accurately using imaging tests like CT or MRI scans.
Must have a good general health status, which is assessed using a scale called ECOG Performance Status. A score of 0 or 1 is required, indicating you are fully active or have some symptoms but can still carry out light work.
Must have a life expectancy of at least 12 weeks, as judged by the doctor.
Can be eligible or ineligible for a specific chemotherapy drug called cisplatin. Ineligibility is based on certain health conditions like reduced kidney function, hearing loss, nerve damage, or severe heart failure.
Must have a known status of a protein called PD-L1 in the tumor, which requires a biopsy, a procedure to take a small sample of the tumor.
Must have adequate function of organs and bone marrow, which includes specific levels of blood cells and liver enzymes.
For women, must either be postmenopausal or have a negative pregnancy test if premenopausal. Postmenopausal means not having menstrual periods for 12 months without another medical reason.

Who Cannot Join the Study?

Patients who have already received chemotherapy for their cancer.
Patients with a different type of cancer that is not transitional cell carcinoma.
Patients with cancer that can be surgically removed.
Patients who are under 18 years old.
Patients who have serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of severe allergic reactions to similar medications.
Patients with active infections that require treatment.
Patients with certain autoimmune diseases, which are conditions where the immune system attacks the body.

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
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
General Oncological Hospital Of Kifissia Agioi Anargyroi	Kifissia	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	13.09.2024
Spain	Not recruiting	13.09.2024

Trial locations

Investigated drugs:

MEDI4736 is a medication being tested in this clinical trial. It is used as a monotherapy, which means it is given alone to see how effective it is in treating patients with a specific type of advanced cancer called unresectable Stage IV urothelial cancer. The goal is to determine if this medication can help patients live longer compared to the standard treatments currently available.

Tremelimumab is another medication involved in this study. It is used in combination with MEDI4736 to see if the two medications together can improve the outcomes for patients with the same type of cancer. The combination therapy aims to enhance the body’s immune response to fight the cancer more effectively than the standard treatments.

Investigated diseases:

Transitional Cell Carcinoma of the Urothelium – This is a type of cancer that originates in the urothelial cells lining the urinary system, including the renal pelvis, ureters, urinary bladder, and urethra. It is characterized by the abnormal growth of transitional cells, which can form tumors. In its advanced stage, known as Stage IV, the cancer is considered unresectable, meaning it cannot be surgically removed. The disease progresses as the cancer cells invade surrounding tissues and may spread to other parts of the body. Patients with this condition are often chemotherapy-naïve, indicating they have not previously undergone chemotherapy treatment. The progression of the disease can lead to various symptoms related to urinary function and general health.

Trial ID:

2024-513399-17-00

Protocol code:

DANUBE/D419BC00001

NCT ID:

NCT02516241

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Durvalumab and Tremelimumab for Patients with Advanced Unresectable Urothelial Cancer

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