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New drug combo shows promise for tough bladder cancer

NCT ID NCT03473743

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests a targeted cancer drug called erdafitinib, alone or combined with an immunotherapy (cetrelimab) and/or chemotherapy, in 125 people with advanced urothelial cancer that has spread. The goal is to find safe doses and see if the treatments shrink tumors. Participants must have specific genetic changes in their cancer cells.

What this could mean

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

Active substance
Erdafitinib (a targeted cancer pill), sometimes combined with cetrelimab (an immunotherapy) and/or platinum chemotherapy (cisplatin or carboplatin)
What this could lead to
If successful, this could provide a new treatment option for people with advanced urothelial cancer who have specific genetic changes, potentially shrinking tumors and delaying progression.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so results may not apply to all patients. Side effects from the drug combinations could be serious, and the treatment may not work for everyone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

125 people

The number who actually took part.

Started

Apr 2018

Expected to finish

Dec 2026

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: * Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable * Metastatic or locally advanced urothelial cancer * Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline * Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (\>) 30 milliliter per minute (mL/min) to receive carboplatin and \>60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2 Exclusion Criteria: * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks * Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given \>12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation * Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (\>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed * Active malignancies requiring concurrent therapy other than urothelial cancer * Symptomatic central nervous system metastases

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Urothelial carcinoma

Contacts and locations

Locations

  • APHM Hopital Timone

    Marseille, 13005, France

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto

    Piacenza, 29121, Italy

  • AZ Nikolaas - Campus Sint-Niklaas Moerland

    Sint-Niklaas, 9100, Belgium

  • Adana Acibadem Hospital

    Adana, 1130, Turkey (Türkiye)

  • Adnan Menderes University Training and Research Hospital

    Aydin, 09100, Turkey (Türkiye)

  • Altai Regional Oncology Dispensary

    Barnaul, 656049, Russia

  • Arcispedale S. Anna Ferrara

    Ferrara, 44124, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Azienda Ospedaliera S. Maria Terni

    Terni, 05100, Italy

  • Azienda Ospedaliero Universitaria S.Maria Della Misericordia

    Udine, 33100, Italy

  • Azienda Socio Sanitaria Territoriale (ASST) della Valtellin

    Sondrio, 23100, Italy

  • Brest Regional Oncology Dispensary

    Brest, 224027, Belarus

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650, Brazil

  • CHRU de Tours

    Tours, 37044, France

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000, Belgium

  • Campus Bio Medico di Roma

    Roma, 00128, Italy

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507, Poland

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre hospitalier Saint Louis

    La Rochelle, 17019, France

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • City Clinical Hospital n.a. D.D.Pletnev

    Moscow, 105077, Russia

  • Clinical Diagnostic Centre of Nizhny Novgorod Region

    Nizhny Novgorod, 603000, Russia

  • Clinical Oncology Dispensary

    Omsk, 644013, Russia

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125, Italy

  • Clinique Sainte Anne

    Strasbourg, 67000, France

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario de Vigo

    Pontevedra, 36204, Spain

  • Complexo Hosp. Univ. de Ourense

    Ourense, 32005, Spain

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 6200, Turkey (Türkiye)

  • Ege University

    Izmir, 35100, Turkey (Türkiye)

  • Fundacao Pio XII

    Barretos, 14784-400, Brazil

  • GUZ Kursk Regional Oncology Dispensary

    Kislino Village, 305524, Russia

  • GZA Ziekenhuizen- Campus St Augustinus

    Wilrijk, 2610, Belgium

  • Gomel Regional Clinical Oncology Dispensary

    Homyel, 246012, Belarus

  • Grodno University Hospital

    Grodno, 230017, Belarus

  • H. Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hacettepe University Medical Faculty

    Ankara, 6100, Turkey (Türkiye)

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hopital Europeen Georges Pompidou

    Paris, 75015, France

  • Hopital Saint André

    Bordeaux, 33075, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28050, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Clinico San Carlos

    Madrid, 28040, Spain

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010, Spain

  • Hosp. Del Mar

    Barcelona, 08003, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. Virgen Macarena

    Seville, 41009, Spain

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Institut de Cancerologie de Ouest (ICO) Site Paul Papin

    Angers, 49055, France

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001, Brazil

  • Istanbul Medeniyet University Goztepe Training and Research Hospital

    Istanbul, 34732, Turkey (Türkiye)

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096, Turkey (Türkiye)

  • Istituto di Candiolo, IRCCS

    Candiolo, 10060, Italy

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040, Russia

  • Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61080, Turkey (Türkiye)

  • Kocaeli University Medical Faculty

    Kocaeli, Turkey (Türkiye)

  • LLC Novaya Clinica

    Pyatigorsk, 357500, Russia

  • LUX MED Onkologia Sp. z o.o.

    Warsaw, 01-748, Poland

  • Leningrad Regional Oncology Dispensary

    Kuzmolovsky, 188663, Russia

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204, United States

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060, Brazil

  • Maryland Oncology Hematology, PA

    Rockville, Maryland, 20850, United States

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Minsk city Clinical Oncological Dispensary

    Minsk, 220013, Belarus

  • Mogilev Regional Hospital

    Mogilev, 212018, Belarus

  • Moscow City Clinical Hospital # 62

    Moscow, 125130, Russia

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041, Russia

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080, Turkey (Türkiye)

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB, United Kingdom

  • Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro

    Fortaleza, 60170-170, Brazil

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905, Brazil

  • Ospedale Civile Di Livorno

    Livorno, 57122, Italy

  • Ospedale Di Zona B Ramazzini

    Carpi, 41012, Italy

  • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

    Perugia, 06132, Italy

  • PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

    Lecco, 23900, Italy

  • Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033, United States

  • Private Medical Institution Euromedservice

    Saint Petersburg, 196603, Russia

  • Privolzhsky District Medical Centre

    Nizhny Novgorod, 603074, Russia

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, 62-500, Poland

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012, United States

  • Royal Lancaster Infirmary

    Lancaster, LA1 4rp, United Kingdom

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758, Russia

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997, Russia

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221, Brazil

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • State Institution N.N. Alexandrov Republican Scientific and

    Lesnoy, 223040, Belarus

  • Tambov Regional Oncology Clinical Dispansary

    Tambov, 392013, Russia

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104, United States

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247, South Korea

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Toledo Clinic Cancer Centers

    Toledo, Ohio, 43623-3536, United States

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • ULB Hôpital Erasme

    Brussels, 1070, Belgium

  • UOS Oncologia Medica, A.O. Cannizzaro

    Catania, 95126, Italy

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG, United Kingdom

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210603, Belarus

  • Weill Cornell Medical College - NY Presbyterian Hospital

    New York, New York, 10021, United States

  • White Plains Hospital Center for Cancer Care

    White Plains, New York, 10601, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513, Poland

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