Study on Atezolizumab for Patients with High-Risk Muscle-Invasive Bladder Cancer with Positive ctDNA After Surgery

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What is this study about?

This clinical trial is focused on studying high-risk muscle-invasive bladder cancer, a type of cancer that affects the bladder and can spread to other parts of the body. The study is investigating the effects of a treatment called atezolizumab, which is a type of medication known as an anti-PD-L1 antibody. This medication is designed to help the immune system recognize and fight cancer cells more effectively. The trial will compare the effects of atezolizumab with a placebo in patients who have undergone surgery to remove the bladder cancer and are found to have circulating tumor DNA (ctDNA) in their blood, which indicates a higher risk of cancer returning.

The purpose of the study is to evaluate how well atezolizumab works in preventing the return of cancer in these patients. Participants in the study will receive either atezolizumab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period of time to assess their disease-free survival, which refers to the length of time patients remain free from cancer after treatment. The study will also look at other factors, such as overall survival and the presence of any side effects from the treatment.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the status of their cancer. These tests may include blood tests to check for ctDNA and other markers, as well as imaging tests to look for any signs of cancer returning. The study aims to provide valuable information on the effectiveness of atezolizumab as an additional therapy for patients with high-risk muscle-invasive bladder cancer, potentially offering a new option for preventing cancer recurrence in this group of patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of high-risk muscle-invasive bladder cancer and a positive test for circulating tumor DNA (ctDNA) following surgery.

2 treatment assignment

Participants are randomly assigned to receive either the medication atezolizumab or a placebo. Atezolizumab is an anti-PD-L1 antibody, which is a type of protein that helps the immune system fight cancer cells.

3 medication administration

The medication or placebo is administered through an intravenous infusion. This means it is given directly into a vein through a drip. The dosage for atezolizumab is 840 mg.

4 treatment schedule

The treatment is given on a regular schedule, which will be explained in detail by the healthcare team. The duration of the treatment phase is determined by the study protocol.

5 monitoring and assessments

Regular monitoring is conducted to assess the effects of the treatment. This includes checking for any changes in health, measuring vital signs, and conducting laboratory tests.

The presence of any side effects or adverse reactions is also monitored closely.

6 follow-up

After the treatment phase, follow-up visits are scheduled to continue monitoring health and any long-term effects of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of muscle-invasive urothelial carcinoma (a type of bladder cancer) with a dominant transitional cell pattern.
  • Must have undergone a surgical procedure to remove the bladder cancer.
  • Must have a tumor sample from surgery that can be used for specific tests, including checking for PD-L1 expression (a protein that may affect cancer growth) and other research purposes.
  • Must provide a blood sample after surgery to identify changes in the tumor’s genetic material.
  • Must provide a blood sample for testing circulating-tumor DNA (ctDNA), which is collected at least 6 weeks after surgery. This test looks for cancer-related DNA in the blood.
  • Must meet specific criteria related to previous treatments and health conditions, such as:
    • Having received or not received platinum-based chemotherapy before surgery. If not received, must be unable to take it due to health reasons, have refused it, or not be given it based on the doctor’s decision.
    • Must have certain health conditions if unable to take cisplatin-based chemotherapy, such as:
      • Impaired renal function: Poor kidney function.
      • Hearing loss: Measured by a hearing test.
      • Peripheral neuropathy: Nerve damage causing tingling or sensory changes.
      • ECOG Performance Status of 2: A scale used to assess how a disease affects daily living abilities.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are included.

Who Cannot Join the Study?

  • Patients who have not had a surgery called a cystectomy, which is the removal of the bladder.
  • Patients who do not have circulating-tumor DNA (ctDNA) within 24 weeks after their cystectomy. This is a type of DNA that comes from cancer cells and is found in the blood.
  • Patients who are not considered high-risk for muscle-invasive bladder cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or are part of a vulnerable population that requires special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Jean Perrin Clermont Ferrand France
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Azienda Ospedaliera S Maria Di Terni Terni Italy
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Institut Sainte Catherine Avignon France
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Immobiliere De Nancy Nancy France
Hospital Universitario Ramon Y Cajal Madrid Spain
Tallaght University Hospital Dublin Ireland
General University Hospital Of Larissa Larissa Greece
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Universitario Reina Sofía Cordoba Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
General University Hospital Of Patras Patras Greece
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Azienda USL Toscana Sud Est Arezzo Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Institut de Cancérologie de l’Ouest Saint-Herblain France
Czjfxm Legp Bgcsyp Lyon France
Hfzzoage Untxlmpmttpdm Mgbugkc Dh Vaejwiqxon Santander Spain
Cjuc Umfuyritxf Hdnyfcmo Cork Ireland
Dunjfoipknlu Cgcwfjy Onwrgotwg Pkvnznfxtuiy I Hestnzzltlp Wroclaw Poland
Iwkaichc Msmswrujcr Myckbjeube Paris France
Pcgz Tccsf Hmvfditx Uzsiwcmutbtg Sabadell Spain
Tzyzzenjep Ceymfw Haokjxkx Thessaloniki Greece
Mgxexb Hqtmlwxr Hfbck Uowuvuqzocaivhxueydp dxs Rpjoyuhlsjsolxxu Bhbbth Herne Germany
Fxntjmjv nqyefgzyn Myonv a Hkixjup Prague Czechia
Iqacayqu Rtkfgqlzm Pqi Li Swbrxq Dpg Tloqtx Dvfm Atqovas Izwl Syzpdf Meldola Italy
Uyljuymzayyxyghzrdrdy Dztfsldfhpl Apx Duesseldorf Germany
Hyyszvwg Uupvehlqhelag Dboipenc Donostia / San Sebastian Spain
Usbrwgbvecwvjrwswzzwz Wpyxcwozk Aik Wuerzburg Germany
Azjdxdt Uupjr Sqryfvioe Lkoxbo Dc Bwqqvab Bologna Italy
Hlekerpe Du Lb Sgvtn Ctzy I Sgch Psi Barcelona Spain
Fxfbdgicx Ptts Ln Imnnkjyyiynbl Biyjcjwkd Dmw Hekellhd Uypuvlzjgivib Lo Pon Madrid Spain
Hyyweyle Vrtz dftstfeo Barcelona Spain
Uboudslmar Gasexkn Hririmdp Aramhnd Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.08.2021
Czechia Czechia
Not recruiting
31.08.2021
France France
Not recruiting
31.08.2021
Germany Germany
Not recruiting
31.08.2021
Greece Greece
Not recruiting
31.08.2021
Ireland Ireland
Not recruiting
31.08.2021
Italy Italy
Not recruiting
31.08.2021
Poland Poland
Not recruiting
31.08.2021
Spain Spain
Not recruiting
31.08.2021

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this clinical trial. It is an antibody that works by blocking a protein called PD-L1. This protein can prevent the immune system from attacking cancer cells. By blocking PD-L1, atezolizumab helps the immune system to recognize and destroy cancer cells more effectively. In this trial, it is being tested as an additional treatment for patients with high-risk muscle-invasive bladder cancer who have undergone surgery to remove the bladder and are found to have circulating tumor DNA, which indicates the presence of cancer cells in the body.

High-risk muscle-invasive bladder cancer – This is a type of bladder cancer that has spread into the muscle layer of the bladder wall. It is considered high-risk due to its potential to grow and spread more aggressively compared to non-muscle-invasive bladder cancer. The disease often begins with symptoms such as blood in the urine, frequent urination, or pain during urination. As it progresses, it may invade surrounding tissues and organs, potentially leading to more severe symptoms. The progression of this cancer can vary, with some cases remaining localized while others may metastasize to distant parts of the body. Regular monitoring and medical evaluation are crucial to understanding its progression.

Trial ID:
2022-502705-15-00
Protocol code:
BO42843
Trial Phase:
Therapeutic confirmatory (Phase III)

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