Study on Atezolizumab with Radiotherapy for Patients with Muscle-Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for muscle-invasive bladder cancer. The treatment being tested is a medication called atezolizumab, which is also known by its code name RO5541267. Atezolizumab is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream. The study aims to evaluate how well atezolizumab works when used together with radiotherapy, a treatment that uses high-energy rays to target and kill cancer cells.

The purpose of the study is to determine if this combination of atezolizumab and radiotherapy can lead to a complete response in patients, which means that the cancer is no longer detectable. Participants in the study will receive atezolizumab and radiotherapy over a period of time, and their response to the treatment will be monitored. The study will assess the effectiveness of the treatment based on specific criteria used to measure cancer response.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to observe any changes in their condition. The study is designed to provide valuable information about the potential benefits of combining atezolizumab with radiotherapy for treating muscle-invasive bladder cancer, with the hope of improving outcomes for patients with this type of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

A negative pregnancy test is required for female participants of childbearing potential within 72 hours prior to registration.

2 treatment initiation

The treatment involves the administration of atezolizumab, a medication given through an intravenous infusion.

The medication used is Tecentriq 1 200 mg concentrate for solution for infusion.

3 concurrent radiotherapy

Radiotherapy is administered concurrently with the atezolizumab treatment.

The aim is to evaluate the effectiveness of this combined approach in treating muscle-invasive bladder cancer.

4 monitoring and assessments

Regular monitoring of health status and response to treatment is conducted throughout the study.

Assessments include blood tests and imaging to evaluate the cancer’s response to the treatment.

5 completion of treatment

The primary endpoint is the evaluation of the pathological complete response, defined as a response of grade 5 according to specific criteria, after the end of the treatment.

The study aims to determine the effectiveness of the treatment in achieving this response.

Who Can Join the Study?

Patients must be 18 years of age or older.
Female participants who can have children should have a negative pregnancy test within 72 hours before joining the study. If the urine test is positive or unclear, a blood test will be needed.
Female participants who can have children should agree to use two methods of birth control, be surgically sterile, or avoid heterosexual activity during the study and for 5 months after the last dose of the study medication. Participants who can have children are those who have not had surgery to prevent pregnancy or have not stopped having periods for more than 1 year.
Male participants should agree to use a reliable method of birth control starting with the first dose of the study treatment and continuing for 120 days after the last dose.
A sample of the tumor, preserved in a special way (paraffin-embedded), must be available for additional study.
Patients must have a confirmed diagnosis of muscle-invasive bladder cancer, specifically a type called urothelial carcinoma, in certain stages (T2-4a N0 M0), and are not suitable for surgery to remove the bladder due to medical reasons, personal choice, or refusal.
Patients who refuse or cannot receive a specific type of chemotherapy called cisplatin-based chemotherapy.
Patients must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a patient can perform daily activities.
Patients must have adequate bone marrow function, which means having a certain level of white blood cells, platelets, and hemoglobin (a protein in red blood cells).
Patients must have adequate kidney and liver function, which includes a certain level of creatinine clearance (a measure of kidney function) and liver enzymes.
Total bilirubin and liver enzymes (SGOT/AST and SGPT/ALT) must be less than 2.5 times the upper limit of normal.
Blood clotting tests, such as International Normalized Ratio (INR) or Prothrombin Time (PT), must be 1.5 times the upper limit of normal or less, unless the participant is on blood-thinning medication and the levels are within the intended range.
Another blood clotting test, Activated Partial Thromboplastin Time (aPTT), must also be 1.5 times the upper limit of normal or less, unless the participant is on blood-thinning medication and the levels are within the intended range.

Who Cannot Join the Study?

Patients who have a different type of cancer other than muscle-invasive bladder cancer cannot participate. This type of cancer affects the bladder muscle.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.

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 Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Salut Sant Joan De Reus	Reus	Spain
Hdxfzgkz Uesnpwekjmucn Df Lq Potpqwbu	Madrid	Spain
Phoe Tleli Hqhuxscd Uqbwvzwdcxzi	Sabadell	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.10.2019

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a medication used in this clinical trial to help the body’s immune system fight cancer cells. It is an immunotherapy drug that works by blocking a protein that can stop the immune system from attacking cancer cells. In this study, it is being used alongside radiotherapy to see if it can improve the treatment outcomes for patients with muscle-invasive bladder cancer.

Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is being used in combination with atezolizumab to evaluate if the combination can lead to a better response in patients with muscle-invasive bladder cancer. The goal is to preserve the bladder while effectively treating the cancer.

Investigated diseases:

Bladder cancer

Muscle-invasive bladder cancer – This is a type of bladder cancer where the cancer cells have spread into the muscle layer of the bladder wall. It often begins in the cells lining the bladder and progresses to invade deeper layers. As the disease advances, it can affect nearby tissues and organs. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression of the disease can lead to more severe symptoms as the cancer spreads. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2024-514604-14-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atezolizumab with Radiotherapy for Patients with Muscle-Invasive Bladder Cancer

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