A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06211764Tipo: INTERVENTIONALInicio: 9 de abr de 2024Fin estimado: 14 de abr de 2031

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\]
Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Criterios de exclusión

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+)
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-200. Participants with tumors involving the prostatic urethra in men will be excluded
A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL)
Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Previous treatment with TAR-200

Intervenciones

drug

TAR-200

Participants will receive TAR-200 intravesically.

drug

Mitomycin C

Participants will receive MMC intravesically.

drug

Gemcitabine

Participants will receive gemcitabine intravesically.

Ubicaciones

Clinica Santa Isabel

Buenos Aires, Argentina

Investigaciones Clinico Moleculares (ICM)

CABA, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Centro Urologico Profesor Bengio

Córdoba, Argentina

Hospital Privado de la Comunidad

Mar del Plata, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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