A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04039607Tipo: INTERVENTIONALInicio: 30 de sept de 2019Fin estimado: 9 de nov de 2026

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have a diagnosis of HCC based on histological confirmation
Participants must have an advanced HCC
Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
Child-Pugh score 5 or 6
Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

Criterios de exclusión

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Prior liver transplant
Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization
Active brain metastases or leptomeningeal metastases

Intervenciones

drug

Nivolumab

Participants will receive nivolumab as intravenous (IV) infusion.

drug

Ipilimumab

Participants will receive ipilimumab as IV infusion.

drug

Sorafenib

Participants will receive sorafenib as oral tablets.

drug

lenvatinib

Participants will receive lenvatinib as oral capsules.

Ubicaciones

Local Institution - 0037

Caba, Buenos Aires, Argentina

Local Institution - 0194

Pilar, Buenos Aires, Argentina

Local Institution - 0282

Rosario, Santa Fe Province, Argentina

Local Institution - 0136

Buenos Aires, Argentina

Local Institution - 0058

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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.

A Randomized, Multi-center, Phase 3 Study of Nivolumab in... | EligiMed