A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (SunRISe-3)
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility Criteria
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
Sites / Locations
- Arkansas UrologyRecruiting
- Genesis Research, LLC - West Coast UrologyRecruiting
- Genesis ResearchRecruiting
- Providence Medical FoundationRecruiting
- Colorado Clinical ResearchRecruiting
- Urological Research NetworkRecruiting
- Blessing HospitalRecruiting
- Urology of IndianaRecruiting
- First UrologyRecruiting
- AMR Kansas City OncologyRecruiting
- Wichita Urology GroupRecruiting
- Chesapeake Urology Research AssociatesRecruiting
- The Urology Center, PCRecruiting
- Associated Medical Professionals of NyRecruiting
- SUNY Upstate Med UnivRecruiting
- Vidant Urology - GreenvilleRecruiting
- Centers for Advanced Urology, LLC; d/b/a MidLantic UrologyRecruiting
- Carolina Urologic Research CenterRecruiting
- Urology AssociatesRecruiting
- Houston Metro UrologyRecruiting
- Urology San Antonio ResearchRecruiting
- George E. Wahlen VAMCRecruiting
- Urology Of Virginia, PllcRecruiting
- Spokane UrologyRecruiting
- Hospital Italiano de Buenos AiresRecruiting
- Sociedade Beneficente de Senhoras - Hospital Sírio LibanêsRecruiting
- Centro Urologico Profesor BengioRecruiting
- Hospital Privado - Centro Medico de CordobaRecruiting
- Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion ClinicaRecruiting
- Hospital Privado de la ComunidadRecruiting
- Instituto Médico Río CuartoRecruiting
- Austin HealthRecruiting
- Macquarie University HospitalRecruiting
- Hollywood Private HospitalRecruiting
- Mater Hospital BrisbaneRecruiting
- ZNA MiddelheimRecruiting
- AZ Sint-JanRecruiting
- AZ Maria MiddelaresRecruiting
- UZ GentRecruiting
- Centre Hospitalier de l'ArdenneRecruiting
- AZ DeltaRecruiting
- VitazRecruiting
- GZA Ziekenhuizen- Campus St AugustinusRecruiting
- Fundacao Pio XIIRecruiting
- NAIC - Nair Antunes Instituto do CâncerRecruiting
- Universidade Estadual De CampinasRecruiting
- Liga Paranaense de Combate ao CancerRecruiting
- Hospital Regional do Câncer - Hospital de EsperançaRecruiting
- Hospital Ana Nery Santa Cruz do SulRecruiting
- Real e Benemérita Associação Portuguesa de BeneficênciaRecruiting
- Fundacao Antonio Prudente - A.C. Camargo Cancer CenterRecruiting
- Nova Scotia Health AuthorityRecruiting
- St Josephs Healthcare HamiltonRecruiting
- Princess Margaret Cancer Centre University Health NetworkRecruiting
- CHUM - Centre hospitalier universitaire de MontrealRecruiting
- CHU de Quebec-Universite Laval-Hopital de l'Enfant-JesusRecruiting
- Peking University First HospitalRecruiting
- Beijing Luhe Hospital, Capital Medical UniversityRecruiting
- The First Bethune Hospital of Jilin UniversityRecruiting
- West China Hospital Sichuan UniversityRecruiting
- Chongqing University Cancer HospitalRecruiting
- People's Hospital of Deyang CityRecruiting
- Sun Yat-Sen University Cancer CenterRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
- Nanjing Drum Tower HospitalRecruiting
- The First Affiliated Hospital of Ningbo UniversityRecruiting
- Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of MedicineRecruiting
- Huadong Hospital Affiliated to Fudan UniversityRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- The Second Hospital of Tianjin Medical UniversityRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & TechnologyRecruiting
- First Affiliated Hospital of Medical College of Xi'an Jiaotong UniversityRecruiting
- Yantai Yuhuangding HospitalRecruiting
- Fakultni nemocnice u sv. Anny v BrneRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Krajská nemocnice Liberec a.s.Recruiting
- Fakultní nemocnice OlomoucRecruiting
- Fakultni nemocnice v MotoleRecruiting
- Thomayerova nemocnice, Onkologicka klinikaRecruiting
- Fakultni nemocnice Kralovske VinohradyRecruiting
- Polyclinique Bordeaux Nord AcquitaineRecruiting
- CHU Gabriel-MontpiedRecruiting
- CHU GrenobleRecruiting
- Polyclinique de Limoges - Francois ChenieuxRecruiting
- Hôpital Edouard HerriotRecruiting
- CHU de Nantes hotel-DieuRecruiting
- CHU NîmesRecruiting
- Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La SourceRecruiting
- Groupe Hospitalier Diaconesses Croix Saint SimonRecruiting
- Hopital Europeen Georges-PompidouRecruiting
- APHP - Hopital Bichat - Claude BernardRecruiting
- Clinical La Croix Du Sud - Ramsay SantéRecruiting
- Chu Rennes - Hopital PontchaillouRecruiting
- CHU RangueilRecruiting
- Urologicum DuisburgRecruiting
- Universitätsklinikum ErlangenRecruiting
- Universitatsklinikum EssenRecruiting
- Universitaetsklinikum FrankfurtRecruiting
- Urologische Partnerschaft Köln UPKRecruiting
- Urologie Neandertal Praxis MettmannRecruiting
- Universitätsklinikum MünsterRecruiting
- Klinikum Nürnberg Nord - HautklinikRecruiting
- Medizinisches Versorgungszentrum - UrologieRecruiting
- Studienpraxis Urologie NürtingenRecruiting
- Caritas-Krankenhaus St. JosefRecruiting
- Universität TübingenRecruiting
- Health Care Global Enterprises pvt LtdRecruiting
- Artemis HospitalRecruiting
- Netaji Subhas chandra Bose Cancer Research InstituteRecruiting
- CIMET's Inamdar Multispeciality HospitalRecruiting
- Generale Regionale F. MiulliRecruiting
- Ospedale Cardinal MassaiaRecruiting
- Ospedale San Giuseppe Moscati di AvellinoRecruiting
- Ospedale San Giacomo Apostolo, Guardia pediatrica territorialeRecruiting
- Ospedale San Raffaele di MilanoRecruiting
- Istituto Europeo di OncologiaRecruiting
- Fondazione G. Pascale - Istituto Nazionale Tumori IRCCSRecruiting
- Ospedale S. Maria Delle CrociRecruiting
- Istituto Nazionale Tumori Regina ElenaRecruiting
- Fuji City General HospitalRecruiting
- Kimitsu Chuo HospitalRecruiting
- Kobe City Medical Center General HospitalRecruiting
- Nagano Municipal HospitalRecruiting
- JRC Nagasaki Genbaku HospitalRecruiting
- Saiseikai Narashino HospitalRecruiting
- Toyama University HospitalRecruiting
- Yamaguchi University HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Pusan National University HospitalRecruiting
- Chungbuk National University HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- Keimyung University Dongsan HospitalRecruiting
- National Cancer CenterRecruiting
- Chonnam National University Hwasun HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Samsung Medical CenterRecruiting
- The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
- Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
- IN VIVO Sp. z o.oRecruiting
- Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZRecruiting
- Centrum MedyczneRecruiting
- Clinical Research Center sp. z o.o MEDIC-R s.k.Recruiting
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,Recruiting
- Provita PoliklinikaRecruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Recruiting
- Hosp. Univ. A CoruñaRecruiting
- Hosp. Punta de EuropaRecruiting
- Fundacion PuigvertRecruiting
- Hosp. Gral. Univ. De CastellonRecruiting
- Hosp. Puerta Del MarRecruiting
- Hosp. Univ. de BellvitgeRecruiting
- Hosp. Univ. Lucus AugustiRecruiting
- Clinica Univ. de NavarraRecruiting
- Hosp. Univ. 12 de OctubreRecruiting
- Hosp. Univ. La PazRecruiting
- Hosp. Virgen de La VictoriaRecruiting
- Hosp. Univ. Marques de ValdecillaRecruiting
- Hosp. Clinico Univ. de ValenciaRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- Chang Kung Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- Taichung Veterans General HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Linkou Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Treatment Group A: TAR-200 + Cetrelimab
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
Treatment Group C: TAR-200 Alone
Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Participants will receive intravesical TAR-200 alone once Q3W.