A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)

CompletadoFase 2ClinicalTrials.gov

ID: NCT04567615Tipo: INTERVENTIONALInicio: 4 de feb de 2021Fin estimado: 19 de nov de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
Must have advanced/metastatic HCC
Have to be immunotherapy treatment-naive in the advanced/metastatic setting
Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
Child-Pugh score of 5 or 6
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale

Criterios de exclusión

Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
Prior organ allograft or allogeneic bone marrow transplantation
No uncontrolled or significant cardiovascular disease
No active known autoimmune disease
Have received one or two lines of tyrosine kinase inhibitor therapies
Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy

Intervenciones

biological

Nivolumab

Specified dose on specified days

biological

Relatlimab

Specified dose on specified days

Ubicaciones

Local Institution - 0010

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0019

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0017

Rosario, Santa Fe Province, Argentina

Local Institution - 0063

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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