A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

CompletadoFase 4ClinicalTrials.gov

ID: NCT02869789Tipo: INTERVENTIONALInicio: 5 de oct de 2016Fin estimado: 13 de may de 2022

Traducción no disponible, mostrando original

Resumen

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
Tissue or Programmed death-ligand 1 (PD-L1) results available
Eastern Cooperative Oncology Group (ECOG) score 2 or
Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
High Tumor Mutation Burden

Criterios de exclusión

Untreated brain metastases
An active malignancy that requires concurrent intervention
Active, known or suspected autoimmune disease
Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Intervenciones

drug

Nivolumab in combination with Ipilimumab

Specified dose on specified days

Ubicaciones

Local Institution - 0008

Capital Federal, Buenos Aires, Argentina

Local Institution - 0006

Viedma, Río Negro Province, Argentina

Local Institution - 0007

CABA, Argentina

Local Institution - 0009

Córdoba, Argentina

Local Institution - 0126

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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