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AzTrials

Urinary Bladder NeoplasmsPhase 2SunRISe-1NCT04640623

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

A Phase 2 study testing TAR-200 and Cetrelimab in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 144 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
What is being tested?
TAR-200 and Cetrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
144 sitesin 16 countries
Study dates
18 Dec 2020to 30 Sep 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
  • All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
  • Participants must be ineligible for or have elected not to undergo radical cystectomy
  • BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

Who cannot join

  • Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
  • Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
  • Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
  • Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Trial locations and contacts

144 sites in 16 countries.

144 sites in 16 countries

United States22 sites

  • Urology Austin

    Austin, Texas, 78745

  • Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • The Urology Group

    Cincinnati, Ohio, 45212

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Foothills Urology - Golden Off

    Golden, Colorado, 80401

  • Urology of Indiana

    Greenwood, Indiana, 46143

  • DuPage Medical Group

    Lisle, Illinois, 60532

  • University of Southern California

    Los Angeles, California, 90033

  • Urology Associates, PC

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • NYU Langone Health

    New York, New York, 10017

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Genesis Healthcare Partners - Genesis Research Greater Los Angeles

    Sherman Oaks, California, 91411

  • Spokane Urology

    Spokane, Washington, 99202

  • SUNY Upstate Medical University

    Syracuse, New York, 13210-2375

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

France20 sites

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Acquitaine

    Bordeaux, 33300

  • CHU Grenoble

    Grenoble, 38043

  • Clinique Sainte Marguerite

    Hyères, 83400

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Centre de Cancerologie du Grand Montpellier

    Montpellier, 34070

  • CHU Nimes

    Nîmes, 30029

  • Hopital Saint Louis

    Paris, 75010

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, 75013

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020

  • Hopital Bichat Claude Bernard

    Paris, 75877

  • Clinical La Croix Du Sud - Ramsay Santé

    Quint-Fonsegrives, 31130

  • Hopital Pontchaillou

    Rennes, 35033

  • CHP Saint Gregoire

    Saint-Grégoire, 35760

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200

  • Hopital Foch

    Suresnes, 92151

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Spain13 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Fund. Puigvert

    Barcelona, 08025

  • Hosp. Puerta Del Mar

    Cadiz, 11009

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Italy11 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70120

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1

    Bari, 70124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50135

  • Ospedale San Martino 1

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144

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

    Torino, 10126

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Japan11 sites

  • Aso Co.,Ltd Iizuka Hospital

    Iizuka, 820-8501

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522

  • Kimitsu Chuo Hospital

    Kisarazu-shi, 292-8535

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025

  • Toranomon Hospital

    Tokyo, 105-8470

  • Toyama University Hospital

    Toyama, 930-0194

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • University of Tsukuba Hospital

    Tsukuba, 305-8520

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

South Korea10 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital

    Seoul, 06273

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Germany9 sites

  • Urologische Partnerschaft Koln UPK

    Cologne, 50968

  • Urologicum Duisburg

    Duisburg, 47169

  • Klinikum Herne - Urologie

    Herne, 44625

  • Matthias Schulze - Germany

    Markkleeberg, 04416

  • Urologie Neandertal Praxis Mettmann

    Mettmann, 40822

  • Universitatsklinikum Munster

    Münster, 48149

  • Schön Klinik Nürnberg Fürth

    Nuremberg, 90491

  • Studienpraxis Urologie Nürtingen - Germany

    Nürtingen, 72622

  • Urologische Praxis am Wasserturm - Germany

    Würselen, 52146

Other trials in Germany

Portugal9 sites

  • Hospital Garcia de Orta

    Almada, 2805-267

  • Uls Regiao Aveiro - Hosp. Infante D. Pedro

    Aveiro, 3810-193

  • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

    Guimarães, 4835-044

  • Centro Hospitalar de Lisboa Central

    Lisbon, 1150-199

  • Fund. Champalimaud

    Lisbon, 1400-038

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674 514

  • Instituto Portugues de Oncologia do Porto Francisco Gentil

    Porto, 4200-072

  • Centro Hospitalar de Vila Nova de Gaia Espinho E P E

    Vila Nova de Gaia, 4434 502

  • Centro Hospitalar de Trás os Montes e Alto-Douro

    Vila Real, 5000508

Other trials in Portugal

Russia9 sites

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • Privolzhsky District Medical Centre

    Nizhny Novgorod, 603074

  • Avicenna Medical Center

    Novosibirsk, 630099

  • A. Tsyb Medical Radiological Research Center

    Obninsk, 249031

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • Ultrasound Clinic 4D

    Pyatigorsk, 357502

  • Saratov State Medical University

    Saratov, 410054

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041

  • Bashkir State Medical University

    Ufa, 450008

Other trials in Russia

Belgium7 sites

  • AZ Sint-Lucas Brugge

    Assebroek, 8310

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • Hopital Erasme

    Brussels, 1070

  • Algemeen ziekenhuis Maria Middelares

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

  • AZ Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

Greece6 sites

  • Metropolitan General A E

    Cholargós, 155 62

  • Athens Medical Center

    Marousi, 151 25

  • Bioclinic - Thessaloniki

    Thessaloniki, 546 22

  • General Hospital of Thessaloniki G. Gennimatas

    Thessaloniki, 54635

  • Euromedica General Clinic

    Thessaloniki, 54645

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, TK 56403

Other trials in Greece

Canada5 sites

  • Exdeo Clinical Research Inc

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Universite de Sherbrooke

    Sherbrooke, Quebec, J1H 5H3

  • Princess Margaret Hospital- UHN

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands4 sites

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

  • Catharina Ziekenhuis

    Eindhoven, 5623EJ

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532SZ

  • The Julius Center - Utrecht Science Park - Stratenum

    Utrecht, 3508 GA

Other trials in Netherlands

Australia3 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Eastern Health Research

    Box Hill, 3128

  • Macquarie University Hospital

    Sydney, 2109

Other trials in Australia

Ukraine3 sites

  • Chernihivskyi oblasnyi onkolohichnyi dyspanser

    Chernihiv, 14029

  • Asklepion LLC

    Kiev, 08173

  • Sumy Regional Clinical Oncology Centre

    Sumy, 40022

Other trials in Ukraine

United Kingdom2 sites

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

Other trials in United Kingdom

About this study

Official title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Being tested
TAR-200, Cetrelimab
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAR-200Drug

    Also called JNJ-17000139, Gemcitabine-Releasing Intravesical System

    TAR-200 will be administered transuretherally.

  • CetrelimabBiological

    Also called JNJ-63723283

    Cetrelimab will be administered.

Study groups in NCT04640623
Study groupRoleWhat they receive
Cohort 1: TAR-200 and CetrelimabExperimentalTAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).
Receives: Drug: TAR-200; Biological: Cetrelimab
Cohort 2: TAR-200ExperimentalTAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Receives: Drug: TAR-200
Cohort 3: CetrelimabExperimentalParticipants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
Receives: Biological: Cetrelimab
Cohort 4: TAR-200 (Participants with Papillary Disease only)ExperimentalTAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Receives: Drug: TAR-200

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate

    Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.

    Measured: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)

  2. Cohort 4: Disease-free Survival (DFS)

    DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.

    Measured: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)

Secondary outcomes (14)

  1. Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response

    DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported.

    Measured: From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)

  2. Overall Survival (OS)

    Measured: From Week 0 up to 6 years 7 months

  3. Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)

    Plasma concentrations of gemcitabine and dFdU were reported.

    Measured: Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose

  4. Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)

    Cmax was defined as maximum observed urine concentration.

    Measured: At Week 0

  5. Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)

    Urine concentrations of gemcitabine and dFdU were reported.

    Measured: At Weeks 3, 6, 9, 15, 18, and 21

  6. Cohort 1and 3: Serum Concentration of Cetrelimab

    Serum concentration of cetrelimab were reported.

    Measured: At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]

  7. Cohort 3: Serum Concentration of Cetrelimab

    Serum concentration of cetrelimab were reported.

    Measured: At Weeks 60 (EOI)

  8. Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies

    Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.

    Measured: From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)

  9. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores

    Measured: From Week 0 up to 6 years 7 months

  10. Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

    Measured: From Week 0 up to 6 years 7 months

  11. Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores

    Measured: From Week 0 up to 6 years 7 months

  12. Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

    Measured: From Week 0 up to 6 years 7 months

  13. Number of Participants With Adverse Events (AEs) by Severity Grades

    Measured: From Week 0 up to 6 years 7 months

  14. Number of Participants With Clinical Laboratory Abnormalities by Severity Grades

    Measured: From Week 0 up to 6 years 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start18 Dec 2020
  3. Primary completion3 Jul 2025
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640623
Sponsor's protocol ID
CR108921
Other IDs
17000139BLC2001, 2020-002646-16, 2023-506146-23-00, 2023
Acronym
SunRISe-1
Status last verified
Nov 2026
First submitted
20 Nov 2020
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
Expanded access
Available

Publications

  • Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Nov 20;43(33):3578-3588. doi: 10.1200/JCO-25-01651. Epub 2025 Jul 30.

    PubMed 40737582

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAR-200 and Cetrelimab in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 144 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, France, Spain, Italy, Japan and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate (time frame: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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