Study Comparing Erdafitinib and Mitomycin for Patients with Intermediate-risk Non-muscle Invasive Bladder Cancer with FGFR Gene Alterations

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What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) that has specific changes in the FGFR gene. The study is comparing two treatments: a new system called TAR-210 that delivers the drug Erdafitinib directly into the bladder, and a single chemotherapy drug also given directly into the bladder. The chemotherapy drugs being studied are Mitomycin and Gemcitabine Hydrochloride. The purpose of the study is to see which treatment is more effective and safe for patients with this type of bladder cancer.

Participants in the study will be randomly assigned to receive either the TAR-210 system or one of the chemotherapy drugs. The study will last for up to 12 months, during which time the effects of the treatments will be monitored. The TAR-210 system uses a special device to place the medication directly into the bladder, which is a non-surgical procedure. The study aims to find out how long it takes for the cancer to return or worsen, or for any other serious health issues to occur.

This trial is important for understanding better treatment options for people with bladder cancer that has FGFR gene changes. By comparing these treatments, researchers hope to improve the management of this disease and provide more effective care for patients in the future.

1 joining the study

Upon joining the study, a diagnosis of intermediate-risk non-muscle invasive bladder cancer with FGFR gene alterations is confirmed. This involves testing either through urine or tumor tissue.

Visible papillary disease must be fully removed before starting the trial, and the absence of disease is confirmed through a screening procedure.

2 randomization

Participants are randomly assigned to one of two groups: Group A or Group B. This process is essential to compare the effectiveness of different treatments.

3 treatment administration

Group A receives the TAR-210 erdafitinib intravesical delivery system. This involves administering the medication directly into the bladder.

Group B receives a single agent intravesical chemotherapy, which could include mitomycin or gemcitabine hydrochloride, also administered directly into the bladder.

4 monitoring and follow-up

Participants undergo regular monitoring to assess the treatment’s effectiveness and any side effects. This includes periodic check-ups and imaging tests.

The primary goal is to measure the time from randomization to the first documented recurrence of bladder cancer, disease progression, or death from any cause.

5 completion of the study

The study is estimated to conclude by June 2028. Participants will be informed of the study’s outcomes and any relevant findings related to their health.

Who Can Join the Study?

Must have a confirmed diagnosis of Intermediate-risk Non-muscle Invasive Bladder Cancer within 90 days before joining the study. This type of cancer affects the bladder but does not invade the muscle.
Must meet at least one of the following conditions:
- Recurrent Ta LG/G1: This means the cancer has come back and is of a low grade.
- Primary and multifocal Ta LG/G1: The cancer is new, low grade, and appears in multiple places.
- Primary and ≥3 cm Ta LG/G1: The cancer is new, low grade, and at least 3 centimeters in size.
- Primary or recurrent Ta G2: The cancer is either new or has come back and is of a slightly higher grade.
Must have at least one of the following risk factors:
- Multiple low-grade tumors.
- A single low-grade tumor larger than 3 centimeters.
- Early recurrence, meaning the cancer comes back within one year.
- Frequent recurrence, meaning the cancer comes back more than once a year.
- Recurrence after previous treatment inside the bladder.
Must have a specific change in the FGFR gene, which can be checked through urine or tumor tissue testing.
Any visible cancer must be completely removed before joining the study, and no disease should be present during a bladder examination called cystoscopy.
Both men and women can participate.
Participants must be adults, typically aged 18 and older.

Who Cannot Join the Study?

Patients with a different type of bladder cancer than the one being studied.
Patients who have a high risk of their cancer spreading or returning.
Patients who have had other types of cancer in the past, unless it was a type that is not likely to come back.
Patients who have had certain treatments for their cancer that might affect the study results.
Patients who have serious health problems that could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or instructions.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Institut Gustave Roussy	Villejuif	France
Urologikum Hamburg MVZ	Hamburg	Germany
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Medical University Of Graz	Graz	Austria
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Gemeinschaftspraxis Haematologie Onkologie	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Mater Misericordiae University Hospital	Dublin	Ireland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Edouard Herriot	Lyon	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Az Maria Middelares Gent	Gent	Belgium
Vitaz	Sint-Niklaas	Belgium
Hospital Universitario De La Ribera	Alzira	Spain
Mazowiecki Szpital Onkologiczny Sp. z o.o.	Wieliszew	Poland
Barmherzige Brueder gemeinnuetzige Traeger GmbH	Straubing	Germany
Fundacio Puigvert	Barcelona	Spain
Polyclinique De Limoges	Limoges	France
Tallaght University Hospital	Dublin	Ireland
Hospital Clinico Universitario De Valencia	Valencia	Spain
Capio La Croix Du Sud	Quint-Fonsegrives	France
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Hospital General Universitario De Castellon	Castello De La Plana	Spain
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie	Tarnow	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Rigshospitalet	Copenhagen	Denmark
Azienda USL Toscana Sud Est	Arezzo	Italy
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Fakultni Thomayerova nemocnice	Prague	Czechia
Region Sjaelland	Holbæk	Denmark
Mater Private Hospital	Dublin	Ireland
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Azorg	Aalst	Belgium
Uniklinikum Salzburg	Salzburg	Austria
Iopnoj Iywykyss Flcbdshhvsaod Oaeappdpejs	Rome	Italy
Ojmuovmewekqge Ldxy Gxzi	Linz	Austria
Ccvi Udrlxikyya Hmrzhhgg	Cork	Ireland
Dkgrumihnxwd Cnolorj Oiqlsxptw Puvknohdiyvk I Hlvnmjgxars	Wroclaw	Poland
Uiwwadkwbhv Pwbjdhmkotcaf Kpxw Uzo	Cologne	Germany
Pmok Ttekq Hnyqsynk Ublqrxkholjw	Sabadell	Spain
Mrjygq Hfvegllr Hgfvk Uvwjoundsddpsaznowdi dbk Rrppvpvblxeezczi Bgceax	Herne	Germany
Fnjhophh nwssspion Mlult a Huqdayf	Prague	Czechia
Hkfinh Hsinogvl	Herlev	Denmark
Aiqnlw Uvcyfohtig Hpagamjh	Aarhus	Denmark
Auuuoxc Olqvphzorxm Umbqqrqjprbxj Cxvmtjegnbub Deika Slybzs E Dhlnx Sahrxxb Ds Trqgon	Turin	Italy
Guwjnx Ulnniugthr Frccnargx	Frankfurt	Germany
Upnuuabpva Os Azoowhl	Edegem	Belgium
Hswfsjwu Vshs dogrbffn	Barcelona	Spain
Iymircsn Pjmnpoeetwlvaah Cpupwq Cwajhm	Marseille	France
Hniebnnr Unyyhwfxwkbhh dq A Civzjg	A Coruna Galicia	Spain
Wayxkaqbqf Szhgijb Ivx Saphluc Ptt W Prfqooufn	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.08.2024
Belgium	Recruiting	01.08.2024
Czechia	Recruiting	01.08.2024
Denmark	Recruiting	01.08.2024
France	Recruiting	01.08.2024
Germany	Recruiting	01.08.2024
Ireland	Not recruiting	01.08.2024
Italy	Recruiting	01.08.2024
Poland	Recruiting	01.08.2024
Spain	Recruiting	01.08.2024

Trial locations

Investigated drugs:

TAR-210 is a new treatment being tested for bladder cancer. It is designed to be delivered directly into the bladder. This method aims to target cancer cells more effectively and reduce side effects compared to traditional treatments. The study is looking at how well this treatment works for people with a specific type of bladder cancer that has certain genetic changes.

Erdafitinib is a medication used in this study to treat bladder cancer. It works by blocking certain proteins that help cancer cells grow. This medication is being tested to see if it can help stop the cancer from coming back or getting worse.

Intravesical Chemotherapy is a standard treatment for bladder cancer where chemotherapy drugs are placed directly into the bladder. This method helps to kill cancer cells in the bladder and is being used in the study to compare its effectiveness against the new treatment being tested.

Investigated diseases:

Bladder transitional cell carcinoma

Non-muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by cancer cells that are found in the tissue lining the inside of the bladder but have not spread into the muscle layer. It is often detected at an early stage and can vary in risk from low to high, depending on factors like tumor size and grade. The disease may cause symptoms such as blood in the urine, frequent urination, or pain during urination. Over time, if not managed, it can progress to muscle-invasive bladder cancer, which is more serious. Monitoring and regular check-ups are crucial to manage the disease and prevent progression.

Trial ID:

2023-507684-19-00

Protocol code:

42756493BLC3004

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Erdafitinib and Mitomycin for Patients with Intermediate-risk Non-muscle Invasive Bladder Cancer with FGFR Gene Alterations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?