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A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
220 patients around the world
Available in United States, Brazil
Janssen Research & Development, LLC
4Research sites
220Patients 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
- 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: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.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.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.
- 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 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:Any malignancy that was not progressing nor requiring treatment change in the last 12 months.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.
Sites
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Hospital Regional do Câncer - Hospital de Esperança
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Beneficência Portuguesa de São Paulo
Recruiting
StudyMoonRISe-3
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Non-muscle-invasive bladder cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06919965
