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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06919965

Registry updated: 2026-09-28
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Description

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Interventions

  • TAR-210 (Drug)
    TAR-210 will be administered intravesically.
  • Mitomycin C (Drug)
    MMC will be administered intravesically.
  • Gemcitabine (Drug)
    Gemcitabine will be administered intravesically.

Eligibility criteria

Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing * All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC * Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population) * Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2 * Must be ineligible for or refusing radical cystectomy (RC) Exclusion criteria: * Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+) * Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence * 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 210 * A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Conditions

Non-Muscle Invasive Bladder Neoplasms

Locations

  • Academic Urology and Urogynecology of Arizona — Sun City, Arizona, United States
  • UCLA — Los Angeles, California, United States
  • Colorado Clinical Research — Lakewood, Colorado, United States
  • Advanced Urology Institute — Largo, Florida, United States
  • Georgia Urology — Atlanta, Georgia, United States
  • Associated Urological Specialists — Chicago Ridge, Illinois, United States
  • UroPartners — Glenview, Illinois, United States
  • Urology of Indiana — Carmel, Indiana, United States
  • Southern Urology LLC — Lafayette, Louisiana, United States
  • Greater Boston Urology — Plymouth, Massachusetts, United States
  • Comprehensive Urology — Royal Oak, Michigan, United States
  • UroHealth Partners — Omaha, Nebraska, United States
  • New Jersey Urology LLC — Voorhees Township, New Jersey, United States
  • Associated Medical Professionals — Syracuse, New York, United States
  • Dayton Physicians Network Urology — Centerville, Ohio, United States
  • The Urology Group — Cincinnati, Ohio, United States
  • Central Ohio Urology Group — Gahanna, Ohio, United States
  • Helios Clinical Research, LLC — Middleburg Heights, Ohio, United States
  • Oregon Urology Institute — Springfield, Oregon, United States
  • MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
  • Keystone Urology Specialists — Lancaster, Pennsylvania, United States
  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
  • The Conrad Pearson Clinic — Germantown, Tennessee, United States
  • Texas Oncology-Austin — Austin, Texas, United States
  • Urology Austin — Austin, Texas, United States
  • Urology San Antonio PA dba USA Clinical Trials — San Antonio, Texas, United States
  • Hospital Sirio Libanes — Buenos Aires, Argentina
  • Instituto Alexander Fleming — Buenos Aires, Argentina
  • Investigaciones Clinico Moleculares (ICM) — Caba, Argentina
  • Centro Urologico Profesor Bengio — Córdoba, Argentina
  • Sanatorio de la Mujer — Rosario, Argentina
  • Hopital Erasme — Brussels, Belgium
  • Ziekenhuis Oost-Limburg — Genk, Belgium
  • AZ Maria Middelares — Ghent, Belgium
  • Universitair Ziekenhuis Leuven — Leuven, Belgium
  • Algemeen Ziekenhuis Delta — Roeselare, Belgium
  • Liga Norte Riograndense Contra O Cancer — Natal, Brazil
  • Hospital Regional do Cancer Hospital de Esperanca — Presidente Prudente, Brazil
  • Funfarme Sjrp — São José do Rio Preto, Brazil
  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo — São Paulo, Brazil
  • Real e Benemerita Associacao Portuguesa de Beneficencia — São Paulo, Brazil
  • Peking University First Hospital — Beijing, China
  • The Third People's Hospital of Chengdu — Chengdu, China
  • West China Hospital Sichuan University — Chengdu, China
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, China
  • Nanjing Drum Tower Hospital — Nanjing, China
  • The First Affiliated Hospital of Ningbo University — Ningbo, China
  • The Second Hospital Of Tianjin Medical University — Tianjin, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology — Wuhan, China
  • Institut Paoli Calmettes — Marseille, France
  • Hopital Saint Louis — Paris, France
  • CHU Pitie Salpetriere — Paris, France
  • Hopital Saint Joseph — Paris, France
  • Clinique de la Croix du Sud — Quint-Fonsegrives, France
  • CHP Saint Gregoire — Saint-Grégoire, France
  • Gustave Roussy — Villejuif, France
  • Universitaetsklinikum Koeln — Cologne, Germany
  • Marien hospital Herne — Herne, Germany
  • Klinikum Leverkusen gGmbH — Leverkusen, Germany
  • Universitaetsklinikum Mannheim — Mannheim, Germany
  • Studienpraxis Urologie Nurtingen — Nürtingen, Germany
  • Caritas-Krankenhaus St. Josef — Regensburg, Germany
  • General Hospital of Athens G Gennimatas — Athens, Greece
  • Laiko General Hospital of Athens — Athens, Greece
  • Sismanogleio General Hospital — Athens, Greece
  • General Hospital Of Thessaloniki Papageorgiou — Thessaloniki, Greece
  • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki — Thessaloniki, Greece
  • Rambam Medical Center — Haifa, Israel
  • Carmel Medical Center — Haifa, Israel
  • Meir Medical Center — Kfar Saba, Israel
  • Rabin Medical Center — Petah Tikva, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
  • Cliniche Humanitas Gavazzeni — Bergamo, Italy
  • ASST Spedali Civili Brescia — Brescia, Italy
  • SPDC Villa Scassi — Genova, Italy
  • Ospedale San Raffaele — Milan, Italy
  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS — Naples, Italy
  • Istituto Nazionale Tumori Regina Elena — Roma, Italy
  • Aou San Luigi Gonzaga — Sanatorio San Luigi, Italy
  • Ospedale S. Maria Della Misericordia — Udine, Italy
  • Juntendo University Hospital — Bunkyō City, Japan
  • Funabashi Municipal Medical Center — Funabashi Shi, Japan
  • Hakodate Goryoukaku Hospital — Hakodate, Japan
  • St Marianna University Hospital — Kawasaki, Japan
  • The Jikei University Hospital — Minatoku, Japan
  • Toho University Sakura Medical Center — Sakura, Japan
  • Yokohama Municipal Citizen's Hospital — Yokohama, Japan
  • Yokohama City University Medical Center — Yokohama, Japan
  • Radboud Umcn — Nijmegen, Netherlands
  • Canisius-Wilhelmina ZH — Nijmegen, Netherlands
  • Erasmus MC — Rotterdam, Netherlands
  • UMC Utrecht — Utrecht, Netherlands
  • Chungbuk National University Hospital — Cheongju-si, South Korea
  • Samsung Medical Center — Gangnam Gu, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital Yonsei University Health System — Seoul, South Korea
  • Hosp Univ A Coruna — A Coruña, Spain
  • Hosp. Clinic de Barcelona — Barcelona, Spain
  • Hosp. Puerta Del Mar — Cadiz, Spain
  • Hosp. Gral. Univ. de Castellon — Castellon, Spain
  • Hosp. Arquitecto Marcide — Ferrol, Spain
  • Hosp. de Jerez de La Frontera — Jerez de la Frontera, Spain
  • Hosp. Univ. 12 de Octubre — Madrid, Spain
  • Hosp Virgen de La Victoria — Málaga, Spain
  • Hosp.Univ.Parc Tauli — Sabadell, Spain
  • Hull University Teaching Hospitals NHS Trust — Cottingham, United Kingdom
  • St Bartholomews Hospital — London, United Kingdom
  • Southampton University Hospital — Southampton, United Kingdom
  • Lister Hospital — Stevenage, United Kingdom
  • Royal Marsden Hospital — Surrey, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record