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Targeted bladder cancer drug takes on chemo in Late-Stage trial

NCT ID NCT06919965

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This phase 3 trial tests a new drug, TAR-210 (erdafitinib), placed directly into the bladder, against standard chemotherapy for people with a high-risk type of bladder cancer that has come back after BCG treatment. The study includes 220 adults whose tumors have certain FGFR gene changes. The main goal is to see if TAR-210 can keep the cancer from returning or getting worse longer than chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAR-210 (erdafitinib) delivered directly into the bladder
What this could lead to
If it works, this could offer a new targeted treatment option for people with a specific type of bladder cancer that has not responded to standard therapy.
What could go wrong
This is a phase 3 trial, but it is still experimental. The drug may not prove better than existing chemotherapy, and side effects from the intravesical delivery system are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing * All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC * Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population) * Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2 * Must be ineligible for or refusing radical cystectomy (RC) Exclusion criteria: * Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+) * Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence * Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210 * A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    111 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Spedali Civili Brescia

    RECRUITING

    Brescia, 25123, Italy

  • AZ Maria Middelares

    RECRUITING

    Ghent, 9000, Belgium

  • Academic Urology and Urogynecology of Arizona

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Advanced Urology Institute

    RECRUITING

    Largo, Florida, 33771, United States

  • Algemeen Ziekenhuis Delta

    RECRUITING

    Roeselare, 8800, Belgium

  • Aou San Luigi Gonzaga

    RECRUITING

    Sanatorio San Luigi, 10043, Italy

  • Associated Medical Professionals

    RECRUITING

    Syracuse, New York, 13210, United States

  • Associated Urological Specialists

    RECRUITING

    Chicago Ridge, Illinois, 60415, United States

  • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

    RECRUITING

    Thessaloniki, 57001, Greece

  • CHP Saint Gregoire

    RECRUITING

    Saint-Grégoire, 35768, France

  • CHU Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

  • Canisius-Wilhelmina ZH

    RECRUITING

    Nijmegen, 6532 SZ, Netherlands

  • Caritas-Krankenhaus St. Josef

    RECRUITING

    Regensburg, 93053, Germany

  • Carmel Medical Center

    RECRUITING

    Haifa, 3436212, Israel

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Centro Urologico Profesor Bengio

    RECRUITING

    Córdoba, X5000KPH, Argentina

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, 28644, South Korea

  • Cliniche Humanitas Gavazzeni

    RECRUITING

    Bergamo, 24125, Italy

  • Clinique de la Croix du Sud

    RECRUITING

    Quint-Fonsegrives, 31130, France

  • Colorado Clinical Research

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Comprehensive Urology

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Dayton Physicians Network Urology

    RECRUITING

    Centerville, Ohio, 45459, United States

  • Erasmus MC

    RECRUITING

    Rotterdam, 3015, Netherlands

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    RECRUITING

    Naples, 80131, Italy

  • Funabashi Municipal Medical Center

    RECRUITING

    Funabashi Shi, 273 8588, Japan

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    RECRUITING

    São Paulo, 01246 000, Brazil

  • Funfarme Sjrp

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • General Hospital Of Thessaloniki Papageorgiou

    RECRUITING

    Thessaloniki, 56429, Greece

  • General Hospital of Athens G Gennimatas

    RECRUITING

    Athens, 115 27, Greece

  • Georgia Urology

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Greater Boston Urology

    RECRUITING

    Plymouth, Massachusetts, 02360, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Hakodate Goryoukaku Hospital

    RECRUITING

    Hakodate, 040 8611, Japan

  • Helios Clinical Research, LLC

    COMPLETED

    Middleburg Heights, Ohio, 44130, United States

  • Hopital Erasme

    RECRUITING

    Brussels, 1070, Belgium

  • Hopital Saint Joseph

    RECRUITING

    Paris, 75014, France

  • Hopital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hosp Univ A Coruna

    RECRUITING

    A Coruña, 15006, Spain

  • Hosp Virgen de La Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hosp. Arquitecto Marcide

    RECRUITING

    Ferrol, 15405, Spain

  • Hosp. Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hosp. Gral. Univ. de Castellon

    RECRUITING

    Castellon, 12004, Spain

  • Hosp. Puerta Del Mar

    RECRUITING

    Cadiz, 11009, Spain

  • Hosp. Univ. 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hosp. de Jerez de La Frontera

    RECRUITING

    Jerez de la Frontera, 11407, Spain

  • Hosp.Univ.Parc Tauli

    RECRUITING

    Sabadell, 08208, Spain

  • Hospital Regional do Cancer - Hospital de Esperanca

    RECRUITING

    Presidente Prudente, 19013-050, Brazil

  • Hospital Sirio Libanes

    RECRUITING

    Buenos Aires, C1419AHN, Argentina

  • Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Cottingham, HU16 5JQ, United Kingdom

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Instituto Alexander Fleming

    RECRUITING

    Buenos Aires, C1426ANZ, Argentina

  • Investigaciones Clinico Moleculares (ICM)

    RECRUITING

    Caba, C1425, Argentina

  • Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Roma, 00144, Italy

  • Juntendo University Hospital

    RECRUITING

    Bunkyō City, 113 8431, Japan

  • Keystone Urology Specialists

    RECRUITING

    Lancaster, Pennsylvania, 17604, United States

  • Klinikum Leverkusen gGmbH

    RECRUITING

    Leverkusen, 51375, Germany

  • Laiko General Hospital of Athens

    RECRUITING

    Athens, 115 27, Greece

  • Liga Norte Riograndense Contra O Cancer

    RECRUITING

    Natal, 59062 000, Brazil

  • Lister Hospital

    RECRUITING

    Stevenage, SG1 4AB, United Kingdom

  • Marien hospital Herne

    RECRUITING

    Herne, 44625, Germany

  • Meir Medical Center

    RECRUITING

    Kfar Saba, 44281, Israel

  • MidLantic Urology

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, 210008, China

  • New Jersey Urology LLC

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • Oregon Urology Institute

    RECRUITING

    Springfield, Oregon, 97477, United States

  • Ospedale S. Maria Della Misericordia

    RECRUITING

    Udine, 33100, Italy

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Radboud Umcn

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    RECRUITING

    São Paulo, 01323 010, Brazil

  • Royal Marsden Hospital

    RECRUITING

    Surrey, SM2 5PT, United Kingdom

  • SPDC Villa Scassi

    RECRUITING

    Genova, 16149, Italy

  • Samsung Medical Center

    RECRUITING

    Gangnam Gu, 06351, South Korea

  • Sanatorio de la Mujer

    RECRUITING

    Rosario, 2000, Argentina

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • Sismanogleio General Hospital

    RECRUITING

    Athens, 15126, Greece

  • Southampton University Hospital

    RECRUITING

    Southampton, SO16 6HU, United Kingdom

  • Southern Urology LLC

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • St Bartholomews Hospital

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • St Marianna University Hospital

    RECRUITING

    Kawasaki, 216 8511, Japan

  • Studienpraxis Urologie Nurtingen

    RECRUITING

    Nürtingen, 72622, Germany

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    RECRUITING

    Guangzhou, 510260, China

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 64239, Israel

  • Texas Oncology-Austin

    RECRUITING

    Austin, Texas, 78731, United States

  • The Conrad Pearson Clinic

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, 315020, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, 325000, China

  • The Jikei University Hospital

    RECRUITING

    Minatoku, 105 8471, Japan

  • The Second Hospital Of Tianjin Medical University

    RECRUITING

    Tianjin, 300211, China

  • The Third People's Hospital of Chengdu

    RECRUITING

    Chengdu, 610014, China

  • The Urology Group

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Toho University Sakura Medical Center

    RECRUITING

    Sakura, 285-8741, Japan

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    RECRUITING

    Wuhan, 430030, China

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UMC Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Universitaetsklinikum Koeln

    RECRUITING

    Cologne, 50937, Germany

  • Universitaetsklinikum Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UroHealth Partners

    COMPLETED

    Omaha, Nebraska, 68114, United States

  • UroPartners

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Urology Austin

    RECRUITING

    Austin, Texas, 78745, United States

  • Urology San Antonio PA dba USA Clinical Trials

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Urology of Indiana

    RECRUITING

    Carmel, Indiana, 46032, United States

  • West China Hospital Sichuan University

    RECRUITING

    Chengdu, 610093, China

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, 232 0024, Japan

  • Yokohama Municipal Citizen's Hospital

    RECRUITING

    Yokohama, 221 0855, Japan

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, 3600, Belgium

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