Estudio de fase II, de un solo brazo, para evaluar la quimioterapia intravesical con gemcitabina/docetaxel en combinación con pembrolizumab sistémico en sujetos con CVNMI de alto riesgo no respondedores o expuestos a la terapia con bacilo de Calmette-Guérin (BCG)

Aún no reclutaFase 2ClinicalTrials.gov

ID: NCT06972615Tipo: INTERVENTIONALInicio: 1 de abr de 2026Fin estimado: 15 de jun de 2030

Resumen

Estudio de intervención de quimioterapia intravesical e inmunoterapia sistémica en el cáncer de vejiga no músculo invasivo (CVNMI).

Descripción detallada

Los pacientes recibirán quimioterapia intravesical cada 3 semanas e inmunoterapia sistémica con pembrolizumab cada 6 semanas, por un total de 1 año de tratamiento.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Be willing and able to provide documented informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
Be ≥18 years of age on the day of signing informed consent.
Have a histologically confirmed diagnosis of high-risk non-muscle invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology. Subjects with predominant or exclusively non-transitional cell histology are not allowed. Confirmation of histology, grade and stage will be performed by central review and must be completed during the screening period and prior to enrollment.
In subjects who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:Attainment of a visually complete resection of all papillary tumors (Ta and T1) 5- Have been treated with adequate BCG therapy and have developed high risk NMIBC that is unresponsive or exposed to BCG therapy.
Adequate BCG therapy must include:
An induction course with at least 5 out of 6 BCG instillations (adequate induction); and
At least 7 out of 9 BCG instillations within 9 months of the first instillation of adequate induction therapy
BCG unresponsive high risk NMIBC is defined as:
Stage progression at 3 months (±4 weeks) despite adequate induction therapy (e.g., Ta to T1, or CIS to T1; note: adequate induction therapy only, defined above, is required in this case); or
High grade T1 disease at the first evaluation after adequate BCG induction or
Persistent high risk NMIBC at 6 months (±4 weeks) after adequate BCG; or
Recurrent high risk NMIBC within 12 months of the last BCG instillation despite having received adequate BCG.
BCG Exposed is defined as: having high-grade persistent (BCG resistant) or recurrent NMIBC within 24 months of the last BCG dose but not meeting the definition of BCG-unresponsive

Criterios de exclusión

\. Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
\. Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle-invasive transitional cell carcinoma of the urothelium.
\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
\. Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/ transurethral resection of bladder tumor to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/ transurethral resection of bladder tumor, during the screening period, such as with chemotherapy as per local/regional practices, is acceptable.)
\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

Intervenciones

drug

intravesical Chemotherapy docetaxel/gemcitabine

intravesical quimiotherapy plus intravenous immunotherapy

Ubicaciones

BLATAM

CABA, Argentina

Patrocinadores

PrincipalBLATAM

Contactos

Gustavo M Villoldo, MD

CONTACT

gvilloldo@blatam.com +541156164207

Martin O Angel, MD

CONTACT

mangel@blatam.com +541149455892

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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