New bladder cancer combo aims to beat standard treatment
NCT ID NCT05714202
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This phase 3 trial tests two new approaches for high-risk bladder cancer that hasn't spread into the muscle. One group gets a drug called TAR-200 placed directly into the bladder plus an immunotherapy drug (cetrelimab). Another group gets TAR-200 alone. These are compared to the standard treatment, BCG. The study includes about 1,135 people who have not had BCG before. The main goal is to see which approach delays cancer return or progression the longest.
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 drug)
- What this could lead to
- If successful, this could offer a new treatment option for high-risk bladder cancer that avoids or delays more aggressive surgery.
- What could go wrong
- This is a large phase 3 trial, but results are not yet available. The new treatments may not be more effective than standard BCG therapy, and side effects from the combination 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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
1,135 people
The number who actually took part.
- Started
-
Mar 2023
- Expected to finish
-
Sep 2029
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 Hide 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 initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ \[CIS\]), in participants who are Bacillus Calmette Guérin (BCG)-naïve * BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible) * All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma \[HGUC\]) for patients with papillary only disease (without CIS) * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 * All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (\<) 2 prior to date of randomization * Participants must be willing to undergo all study procedures Exclusion Criteria: * Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to \[\>=\] T2) * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any 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 * Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded * A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bladder cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
AMR Kansas City Oncology
Merriam, Kansas, 66204, United States
-
APHP - Hopital Bichat - Claude Bernard
Paris, 75018, France
-
AZ Delta
Roeselare, 8800, Belgium
-
AZ Maria Middelares
Ghent, 9000, Belgium
-
AZ Sint-Jan
Bruges, 8000, Belgium
-
AZ Sint-Lucas
Bruges, 8310, Belgium
-
Arkansas Urology
Little Rock, Arkansas, 72211, United States
-
Artemis Hospital
Gurugram, 122001, India
-
Associated Medical Professionals of Ny
Syracuse, New York, 13210, United States
-
Austin Health
Heidelberg, 3084, Australia
-
Avix Investigacion Clinica S C
Monterrey, 64710, Mexico
-
Beijing Hospital
Beijing, 100730, China
-
Beijing Luhe Hospital, Capital Medical University
Beijing, 101100, China
-
Blessing Hospital
Quincy, Illinois, 62301, United States
-
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060-870, Brazil
-
CHU Gabriel-Montpied
Clermont-Ferrand, 63003, France
-
CHU Grenoble
Grenoble, 38043, France
-
CHU Nimes
Nîmes, 30029, France
-
CHU Rangueil
Toulouse, 31059, France
-
CHU de Nantes hotel Dieu
Nantes, 44093, France
-
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Québec, Quebec, G1J1Z4, Canada
-
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, H2X 3E4, Canada
-
CIMET s Inamdar Multispeciality Hospital
Pune, 411040, India
-
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6524 KD, Netherlands
-
Caritas-Krankenhaus St. Josef
Regensburg, 93053, Germany
-
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
-
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
-
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
-
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
-
Central Ohio Urology Group
Gahanna, Ohio, 43230, United States
-
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
Orléans, 45067, France
-
Centre Hospitalier de l'Ardenne
Libramont-Chevigny, 6800, Belgium
-
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
-
Centrum Medyczne
Piotrkow Trybunalski, 97 300, Poland
-
Chang Kung Memorial Hospital
Kaohsiung City, 833, Taiwan
-
Charing Cross Hospital
London, W6 8RF, United Kingdom
-
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
-
China Medical University Hospital
Taichung, 404, Taiwan
-
Chongqing University Cancer Hospital
Chongqing, 400000, China
-
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
-
Chu Rennes Hopital Pontchaillou
Rennes, 35000, France
-
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
-
Cleveland Clinic
Cleveland, Ohio, 44195, United States
-
Clinica Univ. de Navarra
Madrid, 28027, Spain
-
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, 31130, France
-
Clinical Research Center sp z o o MEDIC R s k
Poznan, 61 731, Poland
-
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
-
Consultorio Medico dentro del Hospital Angeles Acoxpa
Mexico City, 14308, Mexico
-
Cooper Health System MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
-
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
-
Duly Health and Care
Lisle, Illinois, 60532, United States
-
Ehime University Hospital
Toon-shi, 791-0295, Japan
-
Eme Red Hospitalaria
Mérida, 97000, Mexico
-
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
-
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
-
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
-
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691, Czechia
-
Fakultni nemocnice v Motole
Prague, 15006, Czechia
-
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
-
First Urology
Jeffersonville, Indiana, 47130, United States
-
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, 80138, Italy
-
Fuji City General Hospital
Fuji-shi, 417-8567, Japan
-
Fund. Puigvert
Barcelona, 08025, Spain
-
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
-
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
-
Fundacao Pio XII
Barretos, 14784-400, Brazil
-
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, 2610, Belgium
-
Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021, Italy
-
Genesis Research
San Diego, California, 92123, United States
-
Genesis Research, LLC - West Coast Urology
Los Alamitos, California, 90720, United States
-
George E. Wahlen VAMC
Salt Lake City, Utah, 84148, United States
-
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
-
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75960, France
-
Health Care Global Enterprises pvt Ltd
Bangalore, 560027, India
-
Henan Cancer Hospital
Zhengzhou, 450008, China
-
Hollywood Private Hospital
Nedlands, 6009, Australia
-
Hopital Europeen Georges-Pompidou
Paris, 75015, France
-
Hosp Univ A Coruna
A Coruña, 15006, Spain
-
Hosp Virgen de La Victoria
Málaga, 29010, Spain
-
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
-
Hosp. Gral. Univ. de Castellon
Castellon, 12004, Spain
-
Hosp. Puerta Del Mar
Cadiz, 11009, Spain
-
Hosp. Punta de Europa
Algeciras, 11207, Spain
-
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
-
Hosp. Univ. La Paz
Madrid, 28046, Spain
-
Hosp. Univ. Lucus Augusti
Lugo, 27003, Spain
-
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
-
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
-
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz do Sul, 96835-090, Brazil
-
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060, Brazil
-
Hospital Italiano de Buenos Aires
Buenos Aires, C1199, Argentina
-
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
-
Hospital Privado de la Comunidad
Mar del Plata, B7602CBM, Argentina
-
Hospital Regional do Cancer - Hospital de Esperanca
Presidente Prudente, 19013-050, Brazil
-
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
-
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
Campinas, 13083-888, Brazil
-
Houston Methodist Hospital
Houston, Texas, 77030, United States
-
Houston Metro Urology
Houston, Texas, 77027, United States
-
Huadong Hospital Affiliated to Fudan University
Shanghai, 200400, China
-
Hunan Province Cancer Hospital
Changsha, 410013, China
-
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
-
Hôpital Edouard Herriot
Lyon, 69437, France
-
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013, France
-
IDOR - Regional Bahia
Salvador, 41253-190, Brazil
-
IN VIVO Sp. z o.o
Bydgoszcz, 85 048, Poland
-
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
-
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67200, France
-
Instituto Medico Rio Cuarto
Río Cuarto, 5800, Argentina
-
Ipo Coimbra
Coimbra, 3000-075, Portugal
-
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
-
Istituto Europeo di Oncologia
Milan, 20141, Italy
-
Istituto Nazionale Tumori Regina Elena
Rome, 00128, Italy
-
JRC Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
-
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
-
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
-
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
-
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
-
Kimitsu Chuo Hospital
Kisarazu-shi, 292-8535, Japan
-
Klinikum Nurnberg Nord
Nuremberg, 90419, Germany
-
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, 81675, Germany
-
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
-
Korea University Anam Hospital
Seoul, 02841, South Korea
-
Krajská nemocnice Liberec a.s.
Liberec, 460 01, Czechia
-
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
-
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
-
Liga Norte Riograndense Contra O Cancer
Natal, 59075-740, Brazil
-
Linkou Chang Gung Memorial Hospital
Taoyuan, 33382, Taiwan
-
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
-
Macquarie University Hospital
Macquarie University, 2109, Australia
-
Mater Hospital Brisbane
South Brisbane, 4101, Australia
-
Matthias Schulze - Germany
Markkleeberg, 04416, Germany
-
Mayo Clinic
Scottsdale, Arizona, 85259, United States
-
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
-
Medizinisches Versorgungszentrum - Urologie
Nuremberg, 90491, Germany
-
NAIC Nair Antunes Instituto do Cancer
Bauru, 17033-495, Brazil
-
Nagano Municipal Hospital
Nagano, 381-8551, Japan
-
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
-
Nanjing Drum Tower Hospital
Nanjing, 210008, China
-
Nara Medical University Hospital
Kashihara-shi, 634-8522, Japan
-
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
-
National Cancer Center
Gyeonggi-do, 10408, South Korea
-
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
-
Netaji Subhas chandra Bose Cancer Research Institute
Kolkata, 700094, India
-
Northwestern University
Chicago, Illinois, 60611, United States
-
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
-
Oncologico Potosino
San Luis Potosí City, 78260, Mexico
-
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
-
Ospedale Cardinal Massaia
Asti, 14100, Italy
-
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
-
Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale
Castelfranco Veneto, 31033, Italy
-
Ospedale San Giuseppe Moscati di Avellino
Avellino, 83100, Italy
-
Ospedale San Raffaele di Milano
Milan, 20132, Italy
-
Peking University First Hospital
Beijing, 100034, China
-
People's Hospital of Deyang City
Deyang, 618000, China
-
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33000, France
-
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000, France
-
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012, India
-
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G 1Z5, Canada
-
Providence Medical Foundation
Santa Rosa, California, 95403, United States
-
Providence Saint Johns Cancer Institute
Santa Monica, California, 90404, United States
-
Provita Poliklinika
Warsaw, 02-647, Poland
-
Pusan National University Hospital
Busan, 49241, South Korea
-
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
-
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 1321 001, Brazil
-
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
-
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
Shanghai, 200025, China
-
SUNY Upstate Med Univ
Syracuse, New York, 13210, United States
-
Saiseikai Narashino Hospital
Narashino-shi, 275-8580, Japan
-
Samsung Medical Center
Seoul, 06351, South Korea
-
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
-
Scunthorpe General Hospital
Scunthorpe, DN15 7BH, United Kingdom
-
Seoul National University Hospital
Seoul, 03080, South Korea
-
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
-
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF, United Kingdom
-
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
-
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
-
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652 900, Brazil
-
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Buenos Aires, C1417, Argentina
-
Spaarne Gasthuis
Hoofddorp, 2134 TM, Netherlands
-
Spokane Urology
Spokane, Washington, 99202, United States
-
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
-
St Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
-
Studienpraxis Urologie Nurtingen
Nürtingen, 72622, Germany
-
Sun Yat Sen University Cancer Center
Guangzhou, 430030, China
-
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
-
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
-
Tata Memorial Hospital
Mumbai, 400012, India
-
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
-
The Emory Clinic Department of Urology
Atlanta, Georgia, 30322, United States
-
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
-
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
-
The First Bethune Hospital of Jilin University
Changchun, 130499, China
-
The Royal Marsden NHS Trust
London, SW3 6JJ, United Kingdom
-
The Second Hospital Of Tianjin Medical University
Tianjin, 300211, China
-
The Urology Center, PC
Omaha, Nebraska, 68114, United States
-
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
-
Thomayerova nemocnice, Onkologicka klinika
Prague, 140 59, Czechia
-
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
-
Toyama University Hospital
Toyama, 930 0194, Japan
-
UC Davis Comprehensive Cancer Center
Sacramento, California, 95630, United States
-
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
-
UZ Gent
Ghent, 9000, Belgium
-
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502, Portugal
-
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1769 001, Portugal
-
Unite de Recherche Clinique du CISSS des Laurentides
Saint Jerome Quebec, Quebec, J7Z 2V4, Canada
-
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
-
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
-
Universitat Tubingen
Tübingen, 72076, Germany
-
Universitatsklinikum Erlangen
Erlangen, 91054, Germany
-
Universitatsklinikum Essen
Essen, 45147, Germany
-
Universitatsklinikum Munster
Münster, 48149, Germany
-
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
-
University of Michigan
Ann Arbor, Michigan, 48109, United States
-
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 556, Poland
-
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
-
Urological Research Network
Hialeah, Florida, 33016, United States
-
Urologicum Duisburg
Duisburg, 47169, Germany
-
Urologie Neandertal Praxis Mettmann
Mettmann, 40822, Germany
-
Urologische Partnerschaft Koln UPK
Cologne, 50968, Germany
-
Urology Associates
Nashville, Tennessee, 37209, United States
-
Urology Austin
Austin, Texas, 78745, United States
-
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
-
Urology Of Virginia, Pllc
Virginia Beach, Virginia, 23462, United States
-
Urology San Antonio Research
San Antonio, Texas, 78229, United States
-
Urology of Indiana
Carmel, Indiana, 46032, United States
-
VA Long Beach Health Care System
Long Beach, California, 90822, United States
-
VA NY Harbor Healthcare System
New York, New York, 10010, United States
-
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
-
Vidant Urology - Greenville
Greenville, North Carolina, 27834, United States
-
Vitaz
Sint-Niklaas, 9100, Belgium
-
West China Hospital Sichuan University
Chengdu, 610044, China
-
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
-
Wichita Urology Group
Wichita, Kansas, 67226, United States
-
Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, 76-200, Poland
-
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20 708, Poland
-
Yamaguchi University Hospital
Ube, 755-8505, Japan
-
Yantai Yuhuangding Hospital
Yantai, 264000, China
-
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
-
ZNA Middelheim
Antwerp, 2020, Belgium
-
Zhejiang Provincial People's Hospital
Hangzhou, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dutch bladder cancer cohort aims to map survival and recurrence
- Can two drugs plus chemoradiation let bladder cancer patients keep their bladder?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?