A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03383458Tipo: INTERVENTIONALInicio: 18 de abr de 2018Fin estimado: 27 de feb de 2031

Traducción no disponible, mostrando original

Resumen

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
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
Any evidence of tumor metastasis or co-existing malignant disease
Participants previously receiving any prior therapy for HCC, including loco-regional therapies
Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).

Intervenciones

biological

Nivolumab

Specified dose on specified days

other

Placebo

specified dose on specified days

Ubicaciones

Local Institution - 0243

Gorriti, Buenos Aires, Argentina

Local Institution - 0254

Pilar, Buenos Aires, Argentina

Local Institution - 0244

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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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