Estudio de fase 3, aleatorizado, para evaluar la eficacia y seguridad del sistema de administración intravesical de erdafitinib TAR-210 versus quimioterapia intravesical con un único agente en participantes con cáncer de vejiga no músculo-invasivo de riesgo intermedio (CVNMI-RI) y alteraciones susceptibles de FGFR

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06319820Tipo: INTERVENTIONALInicio: 18 de abr de 2024Fin estimado: 31 de dic de 2032

Resumen

El objetivo principal de este estudio es comparar la supervivencia libre de enfermedad entre los participantes que reciben tratamiento con TAR-210 frente a quimioterapia intravesical a elección del investigador para el tratamiento del CVNMI de riesgo intermedio.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm
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
Participants 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 arm.
Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
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 treatment
Have an Eastern Cooperative Oncology Group performance status of 0 to 2

Criterios de exclusión

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 drugs
Presence 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 chemotherapy
Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (mL)
Current indwelling urinary catheters, however, intermittent catheterization is acceptable
Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
Substudy:
\- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

Intervenciones

combination_product

TAR-210

TAR-210 will be administered intravesically.

drug

Gemcitabine

Gemcitabine will be administered intravesically.

drug

MMC

MMC will be administered intravesically.

Ubicaciones

Hospital Sirio Libanes

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigaciones Clinico Moleculares (ICM)

CABA, Argentina

ACTIVE_NOT_RECRUITING

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

ACTIVE_NOT_RECRUITING

Centro Urologico Profesor Bengio

Córdoba, Argentina

ACTIVE_NOT_RECRUITING

Hospital Privado de la Comunidad

Mar del Plata, Argentina

ACTIVE_NOT_RECRUITING

Sanatorio de la Mujer

Rosario, Argentina

ACTIVE_NOT_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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