A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
NCT ID: NCT06919965
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2025-09-10
2032-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: TAR-210
Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.
TAR-210
TAR-210 will be administered intravesically.
Group B: Mitomycin C (MMC) or Gemcitabine
Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.
Mitomycin C
MMC will be administered intravesically.
Gemcitabine
Gemcitabine will be administered intravesically.
Interventions
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TAR-210
TAR-210 will be administered intravesically.
Mitomycin C
MMC will be administered intravesically.
Gemcitabine
Gemcitabine will be administered intravesically.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Georgia Urology
Atlanta, Georgia, United States
UroHealth Partners
Omaha, Nebraska, United States
Dayton Physicians Network Urology
Centerville, Ohio, United States
Helios Clinical Research, LLC
Middleburg Heights, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
MidLantic Urology
Lancaster, Pennsylvania, United States
The Conrad Pearson Clinic
Germantown, Tennessee, United States
Urology Austin
Austin, Texas, United States
Urology San Antonio PA dba USA Clinical Trials
San Antonio, Texas, United States
Liga Norte Riograndense Contra O Cancer
Natal, , Brazil
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente, , Brazil
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
São José do Rio Preto, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, , Brazil
West China Hospital Sichuan University
Chengdu, , 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
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Funabashi Municipal Medical Center
Funabashi Shi, , Japan
Hakodate Goryoukaku Hospital
Hakodate, , Japan
St Marianna University Hospital
Kawasaki, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
Yokohama Municipal Citizen's Hospital
Yokohama, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
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
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
Countries
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Central Contacts
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Other Identifiers
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42756493BLC3005
Identifier Type: OTHER
Identifier Source: secondary_id
2024-519493-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
42756493BLC3005
Identifier Type: -
Identifier Source: org_study_id