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Bladder cancer drug combo shows promise in patients who Can't have chemo

NCT ID NCT04919512

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of two drugs—TAR-200 (placed directly into the bladder) and cetrelimab (an immunotherapy given by IV)—in 163 people with muscle-invasive bladder cancer who were scheduled for bladder removal surgery and could not or would not take standard chemotherapy. The main goal was to see if the treatment could completely eliminate cancer cells in the bladder tissue removed during surgery. The study also tracked side effects and cancer recurrence.

What this could mean

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

Active substance
TAR-200 (a drug placed in the bladder) and cetrelimab (an immunotherapy given by IV)
What this could lead to
If successful, this combination could offer a new treatment option for bladder cancer patients who cannot take standard chemotherapy, potentially improving outcomes before surgery.
What could go wrong
This is a phase 2 trial with a relatively small number of participants (163). The results may not confirm benefit in larger studies, and side effects from the drugs could be significant.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

163 people

The number who actually took part.

Started

Jul 2022

Finished

Mar 2026

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 proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible * Participants with no residual tumor, or intravesical tumor size of less than or equal to (\<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (\>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is \>3 cm after debulking TURBT * Deemed eligible for and willing to undergo RC by the operating urologist * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1 * Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results * All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (\<) 2 prior to randomization Exclusion Criteria: * Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment * Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central radiology staging (chest, abdomen, and pelvis must be performed using computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) within 42 days prior to randomization * 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-200 * Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time * Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment * Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

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

Urinary bladder neoplasms

Contacts and locations

Locations

  • ASL Napoli 2 Nord-SM delle Grazie Hospital

    Pozzuoli, 80078, Italy

  • AZ Sint Jan Brugge Oostende AV

    Bruges, 8000, Belgium

  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

    Frankfurt am Main, 60431, Germany

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8310, Belgium

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals

    Syracuse, New York, 13210, United States

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Barts Health NHS Trust

    London, EC1A 7BE, United Kingdom

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU Nimes

    Nîmes, 30029, France

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532SZ, Netherlands

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Centre Interuniversitaire Ambroise Pare - Ambroise Paré

    Mons, 7000, Belgium

  • City of Hope

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    Madrid, 28027, Spain

  • Clinical La Croix Du Sud - Ramsay Santé

    Quint-Fonsegrives, 31130, France

  • Clinique Pasteur

    Toulouse, 31076, France

  • Clinique Tivoli Ducos

    Bordeaux, 33000, France

  • Colorodo Urology- St. Anthony Hospital

    Golden, Colorado, 80401, United States

  • David C. Pratt Cancer Center

    St Louis, Missouri, 63141, United States

  • DuPage Medical Group

    Lisle, Illinois, 60532, United States

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65201, United States

  • First Urology

    Jeffersonville, Indiana, 47130, United States

  • Fund. Puigvert

    Barcelona, 08041, Spain

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Genesis Research

    San Diego, California, 92123, United States

  • HIA se Sainte-Anne - Toulon

    Toulon, 83041, France

  • Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Haga ziekenhuis

    The Hague, 2545 AA, Netherlands

  • Hopital Bichat Claude Bernard

    Paris, 75877, France

  • Hopital Europeen Georges-Pompidou

    Paris, 75015, France

  • Hopital Henri Mondor

    Créteil, 94000, France

  • Hopital de Jolimont

    Haine Saint Paul La Louviere, 7100, Belgium

  • Hopital de la Timone

    Marseille, 13005, France

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39002, Spain

  • Hosp. Univ. San Cecilio

    Granada, 18016, Spain

  • Hospices Civils de Lyon HCL

    Pierre-Bénite, 69495, France

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Hôpital Privé Le Bois

    Lille, 59000, France

  • ICH Hopital A. Morvan

    Brest, 29200, France

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Inje University Haeundae Paik Hospital

    Busan, 612-030, South Korea

  • Istituto Dei Tumori Di Milano

    Milan, 20133, Italy

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

    Preston, PR2 9HT, United Kingdom

  • Marien hospital Herne

    Herne, 44625, Germany

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic 1

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Mount Sinai Queens Infusion Center

    Astoria, New York, 11102, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • New York University Langone Medical Center

    New York, New York, 10017, United States

  • Ospedale Civile Ramazzini

    Carpi, 41012, Italy

  • Ospedale San Giuseppe Moscati di Avellino

    Avellino, 83100, Italy

  • Penn Medicine - PerelmanCenter for Advanced Medicine

    Baltimore, Maryland, 21218, United States

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000, France

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Rabin Medical Center - Hasharon Hospital

    Petah Tikva, 49372, Israel

  • Radboud Umcn

    Nijmegen, 6525 GA, Netherlands

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901, United States

  • SPDC Villa Scassi

    Genova, 16100, Italy

  • SUNY Upstate Medical University

    Syracuse, New York, 13202, United States

  • Samsung Medical Center

    Gangnam Gu, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Staedtisches Klinikum Braunschweig

    Braunschweig, 38118, Germany

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591, South Korea

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621, Israel

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UAMS Winthrop P. Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205, United States

  • Universitaetsklinikum Halle Saale

    Halle, 06120, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University Of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • University of Washington School of Medicine

    Seattle, Washington, 98195, United States

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741, United States

  • Urology Associates

    Nashville, Tennessee, 37209, United States

  • Urology San Antonio Research

    San Antonio, Texas, 78229, United States

  • Urology of Indiana

    Indianapolis, Indiana, 46260, United States

  • Vivantes Klinikum Am Urban

    Kreuzberg, 10967, Germany

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27103, United States

  • Washington University School Of Medicine - Center For Advanced Medicine (CAM)

    St Louis, Missouri, 63110-1010, United States

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322, United States

  • ZNA Jan Palfijn

    Merksem, 2170, Belgium

  • Ziekenhuis Oost-Limburg

    Genk, 3600, Belgium

  • Ziekenhuisgroep Twente

    Almelo, 7600, Netherlands

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