Estudio de fase 3, aleatorizado, abierto, multicéntrico, que evalúa la eficacia y seguridad del sistema de administración intravesical de erdafitinib TAR-210 frente a la elección del investigador de quimioterapia intravesical en participantes con cáncer de vejiga no músculo-invasivo de alto riesgo con alteraciones susceptibles de FGFR que han recibido bacilo de Calmette-Guérin (BCG) intravesical

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06919965Tipo: INTERVENTIONALInicio: 10 de sept de 2025Fin estimado: 16 de mar de 2032

Resumen

El objetivo principal de este estudio es comparar la supervivencia libre de enfermedad (el tiempo transcurrido desde la aleatorización hasta que un participante sobrevive sin signos ni síntomas de recurrencia o progresión del cáncer) entre los participantes tratados con bacilo de Calmette-Guérin (BCG) que reciben tratamiento con TAR-210 frente a la elección del investigador de quimioterapia intravesical para el tratamiento del cáncer de vejiga no músculo-invasivo de alto riesgo (HR-NMIBC).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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: 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)

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 \[i.e.\], 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: 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

Intervenciones

drug

TAR-210

TAR-210 will be administered intravesically.

drug

Mitomycin C

MMC will be administered intravesically.

drug

Gemcitabine

Gemcitabine will be administered intravesically.

Ubicaciones

Hospital Sirio Libanes

Buenos Aires, Argentina

RECRUITING

Instituto Alexander Fleming

Buenos Aires, Argentina

RECRUITING

Investigaciones Clinico Moleculares (ICM)

Caba, Argentina

RECRUITING

Centro Urologico Profesor Bengio

Córdoba, Argentina

RECRUITING

Sanatorio de la Mujer

Rosario, Argentina

RECRUITING

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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