A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

CompletadoFase 3ClinicalTrials.gov

ID: NCT04003636Tipo: INTERVENTIONALInicio: 24 de sept de 2019Fin estimado: 1 de abr de 2025

Traducción no disponible, mostrando original

Resumen

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Has a life expectancy of greater than 3 months
Has adequate organ function

Criterios de exclusión

Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
Has ampullary cancer
Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
Has had an allogenic tissue/solid organ transplant

Intervenciones

biological

Pembrolizumab

Pembrolizumab by intravenous (IV) infusion

drug

Gemcitabine

Gemcitabine by IV infusion

drug

Cisplatin

Cisplatin by IV infusion

drug

Placebo

Placebo to pembrolizumab

Ubicaciones

CEMIC ( Site 0581)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Favaloro ( Site 0578)

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Centro Medico San Roque ( Site 0579)

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)

CABA, Argentina

Centro Oncologico Riojano Integral ( Site 0584)

La Rioja, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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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