Estudio global, de fase III, aleatorizado, abierto, controlado y multicéntrico de durvalumab en primera línea en combinación con quimioterapia estándar y durvalumab en combinación con tremelimumab y quimioterapia estándar versus quimioterapia estándar sola en pacientes con cáncer urotelial localmente avanzado irresecable o metastásico.

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03682068Tipo: INTERVENTIONALInicio: 27 de sept de 2018Fin estimado: 29 de abr de 2026

Resumen

Este es un estudio global de fase III, aleatorizado, abierto, controlado y multicéntrico para determinar la eficacia y seguridad de la combinación de durvalumab ± tremelimumab con quimioterapia estándar (doblete cisplatino + gemcitabina o carboplatino + gemcitabina), seguida de monoterapia con durvalumab, frente al tratamiento estándar solo como quimioterapia de primera línea en pacientes con carcinoma de células transicionales del urotelio (incluidos pelvis renal, uréteres, vejiga urinaria y uretra) histológica o citológicamente documentado, irresecable, localmente avanzado o metastásico.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)
Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred \>12 months from the last therapy \[for chemoradiation and adjuvant treatment\] or \>12 months from the last surgery \[for neoadjuvant treatment\].
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
Adequate organ and marrow function as defined in the protocol
Life expectancy ≥12 weeks in the opinion of the investigator
Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

Criterios de exclusión

Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
No severe concomitant condition that requires immunosuppression medication
Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
Patients who may be eligible for or are being considered for radical resection during the course of the study.
Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

Intervenciones

drug

Durvalumab

Durvalumab IV (intravenous infusion)

drug

Tremelimumab

Tremelimumab IV (intravenous infusion)

drug

Cisplatin + Gemcitabine

Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

drug

Carboplatin + Gemcitabine

Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Ubicaciones

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

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.

Estudio global, de fase III, aleatorizado, abierto, contr... | EligiMed