Last updated 16 days ago
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
540 patients around the world
Available in Spain, Argentina, United States
Janssen Research & Development, LLC
5Research sites
540Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 testingParticipants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that armVisible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method)Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatmentHave an Eastern Cooperative Oncology Group performance status of 0 to 2
- Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugsPresence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapyPolyuria with recorded 24-hour urine volumes greater than (>) 4000 mLCurrent indwelling urinary catheters, however, intermittent catheterization is acceptableHad major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
Sites
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Centro Urológico Profesor Bengió - Córdoba
Recruiting
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Hospital Privado de la Comunidad
Recruiting
Centro Gutman
Recruiting
StudyMoonRISe-1
SponsorJanssen Research & Development, LLC
Conditions
Non-muscle-invasive bladder cancerBladder Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06319820
