Study of Atezolizumab with BCG Treatment for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Who Have Not Previously Received BCG

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What is this study about?

This study focuses on patients with high-risk non-muscle invasive bladder cancer who have undergone transurethral resection of the bladder. The research evaluates a treatment combining two medications: atezolizumab (given through intravenous infusion) and BCG (Bacillus Calmette-Guerin), which is administered directly into the bladder. The purpose is to determine if using both treatments together works better than using BCG alone.

The treatment plan involves receiving Tecentriq (atezolizumab) as an intravenous solution, with each dose containing 1,200 milligrams of medication. Patients will receive treatment for up to 12 months. During this time, some patients will receive both atezolizumab and BCG bladder treatments, while others will receive only BCG treatments.

Throughout the study, patients will have regular check-ups to monitor their health. These visits include medical examinations and quality of life assessments. The doctors will track how long patients remain free from cancer events and watch for any signs that the disease has returned or gotten worse. Blood and urine samples will be collected to study how the treatment is working.

1 Initial evaluation

Your participation begins after completing the surgical procedure and receiving confirmation of high-risk non-muscle invasive bladder cancer

Medical imaging (CT scan or MRI) must be performed within 90 days before starting treatment to confirm the absence of cancer spread

Basic health tests including blood pressure and laboratory tests will be conducted within 7 days before starting treatment

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: BCG treatment alone (bladder instillation)

Group 2: BCG treatment plus atezolizumab (bladder instillation plus intravenous medication)

3 Treatment period – Year 1

Treatment will continue for one year

You will receive BCG instillations directly into your bladder

If assigned to group 2, you will also receive Tecentriq (atezolizumab) 1,200 mg through intravenous infusion

4 Monitoring and evaluation

Regular check-ups will occur every 12 weeks during the first two years

Health assessments will include cystoscopy (bladder examination) and urine tests

Quality of life questionnaires will be completed every 12 weeks

Side effects will be monitored and recorded throughout the study

5 Long-term follow-up

After the first two years, check-ups will occur every 24 weeks for years 3-5

Continued monitoring of your health status and cancer-related events

The total study duration is expected to continue until October 2028

Who Can Join the Study?

Must be at least 18 years old (adult men and women)
Must have signed an informed consent form after the last bladder surgery
Must have high-risk non-muscle invasive bladder cancer confirmed by tissue examination
Must have had at least two surgical removals of the primary tumor
Must have no spread of cancer to pelvis, abdomen, or chest, confirmed by CT or MRI scan within the last 90 days
Must have an ECOG performance status of 2 or less (ability to perform daily activities)
Must have a life expectancy of at least 12 weeks
Must have controlled blood pressure (systolic below 160 mmHg and diastolic below 95 mmHg)
Must have adequate blood test results and organ function within 7 days before treatment
Must be registered in the social security system
Women who can become pregnant must agree to either avoid sexual intercourse or use highly effective contraception during treatment and for 5 months after the last dose of medication
Must be willing and able to follow the study protocol, including all treatments, scheduled visits, and examinations
Must have tumor tissue available for laboratory testing

Who Cannot Join the Study?

History of autoimmune diseases (conditions where the body’s immune system attacks healthy cells)
Previous treatment with BCG therapy that was not successful
Active or untreated tuberculosis
Known allergies to any of the study medications
Presence of metastatic disease (cancer that has spread to other parts of the body)
Significant heart, liver, or kidney problems
Current participation in other clinical trials
Pregnant or breastfeeding women
Major surgery within 4 weeks before starting the study
Active or chronic infections requiring treatment
Previous treatment with immunotherapy medications
Mental conditions that could interfere with study compliance
History of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer)
Conditions requiring long-term use of steroids or other immunosuppressive medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Tenon	Paris	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Hopital Prive Toulon Hyeres Sainte Marguerite	Hyeres	France
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Prive Des Cotes D’armor	Plerin	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
CHU Helora	La Louviere	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Centre Briochin d’Urologie	Plerin	France
Ctsdda Hicvehazsyg Rnnevsvk Dxeevcqgpmrlnd	Angers	France
Ijqjnimq Mwgovlymtj Mijmpcjglj	Paris	France
Hhqlkph Phmej Ln Lqplidxu	Lille	France
Chmeobdw	Ermont	France
Cjpoxap leqmgrj	Lille	France
Arxgpxqgdn Pqmigqxq Hxzxmqpr Dm Peqec	Paris	France
Awfcvxfkqi Poabjjqs Hjaodigb Df Mgbvqpwqp	Marseille	France
Cdppaq Hyhczdjrnwx Rniurhfn Ubtcueavkglpv Dr Taprp	Tours	France
Ggewjl Hsjgwwirula Ualpzzdesutjx Pjrst Ptlzyiqpwdc Es Njzqpghdufme	Paris	France
Fmmsxtdns Pliq La Izjmjmxrinvol Bhkzbzcfa Dhr Hnswlxqv Uvrjvwfixdxzw Ly Pso	Madrid	Spain
Inyyvfbb Peowbnvmqddezlz Cocdtw Cnarrp	Marseille	France
Hwwmofil Uwidulmbmpgjg dd A Cncgwu	A Coruna Galicia	Spain
Cts Kndnsay Bmjccke	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	17.12.2018
France	Not yet recruiting	17.12.2018
Spain	Not yet recruiting	17.12.2018

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from your immune system, allowing your body’s natural defenses to better recognize and attack the cancer.

BCG (Bacillus Calmette-Guerin) is a treatment that’s placed directly into the bladder through a catheter. It’s made from weakened bacteria that stimulate your immune system to fight cancer cells in the bladder. This is a standard treatment for high-risk bladder cancer that hasn’t invaded the muscle wall.

Investigated diseases:

Bladder cancer

Non-muscle invasive bladder cancer – A type of bladder cancer that affects the inner lining of the bladder without invading the muscle layer. The cancer starts in the cells that line the bladder and can form small growths called papillary tumors or flat areas known as carcinoma in situ (CIS). The disease can occur in different stages, from very early superficial tumors to those that have grown deeper into the bladder lining. When classified as high-risk, it means the cancer has certain characteristics that make it more likely to return after initial treatment. The condition is typically discovered after patients experience symptoms such as blood in urine or changes in urination patterns.

Trial ID:

2024-517621-54-00

Protocol code:

UC-0160/1717

NCT ID:

NCT03799835

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Atezolizumab with BCG Treatment for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Who Have Not Previously Received BCG

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?