Klinische Studie
A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator’s Choice of Intravesical Chemotherapy in Participants with High-risk Non-muscle-invasive Bladder Cancer with Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)(MoonRISe-3)TAR-210 Versus Intravesical Chemotherapy in High-Risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) with Susceptible FGFR Alterations
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. Histologically confirmed diagnosis by local histopathology of papillary-only
HR-NMIBC (defined as HG 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.
2. Have a susceptible FGFR mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing.
3. All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for HG UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC.
4. Participants must have:
Had adequate induction course of BCG (5 of 6 doses) and either 2 of 3 doses of maintenance BCG or 2 of 6 doses of second induction course of BCG, with HG T1 disease at first disease assessment after induction or HG Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population).
OR
Had adequate induction course of BCG (5 or 6 doses) with or without maintenance BCG with HG Ta/any T1 disease within 12 months after last BCG excluding BCGunresponsive (BCG-experienced population).
OR
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).
5. For participants with BCG-unresponsive or BCG-experienced disease:
Diagnosis of recurrence must be within 90 days prior to screening.
Participants with BCG-unresponsive disease (recurrence) must have HG T1 disease at first disease assessment after Induction or HG Ta/any T1 disease within 6 months after last BCG.
Participants with BCG-experienced disease (recurrence) must have HG Ta/any T1 disease within 12 months after last BCG.
For BCG-intolerant participants:
For participants without recurrence after BCG: qualifying diagnosis must be within 180 days prior to screening and most recent BCG instillation was within 90 days prior to start of screening.
For participants with recurrence: must have HG Ta/any T1 disease within 12 months after the last BCG instillation, and diagnosis of recurrence must be within 90 days prior to screening.
Wesentliche Ausschlusskriterien1. 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 UC (ie, T2,T3, T4, N+, and/or M+).
2. Must not currently have UC or histological variant at any site outside of the urinary bladder. UC of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization with no evidence of recurrence.
3. N+ and/or M+ per BICR of CT/MR Urography.
4. Received serial intravesical therapy or systemic therapy from the time of histologic diagnosis of recurrent HR-NMIBC to date of randomization. Immediate post-TURBT single-dose per-operative intravesical chemotherapy is allowed in accordance with institutional guidelines.
5. Prior application of TAR-210 within 6 months of randomization or prior intravesical chemotherapy with gemcitabine or mitomycin within 6 months of randomization.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de