A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

CompletadoFase 2ClinicalTrials.gov

ID: NCT03668119Tipo: INTERVENTIONALInicio: 31 de oct de 2018Fin estimado: 2 de ago de 2023

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
Must be able to provide tissue and blood TMB-H testing results
Must have measurable disease for response assessment

Criterios de exclusión

Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment

Intervenciones

biological

Nivolumab

Specified dose on specified days

biological

Ipilimumab

Specified dose on specified days

Ubicaciones

Local Institution - 0016

Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina

Local Institution - 0087

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0078

CABA, Argentina

Local Institution - 0015

CABA, Argentina

Local Institution - 0119

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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