A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers

CompletadoFase 2ClinicalTrials.gov

ID: NCT03377361Tipo: INTERVENTIONALInicio: 31 de ene de 2018Fin estimado: 4 de nov de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)

Criterios de exclusión

BRAF V600 mutant colorectal cancer
Active brain metastases or leptomeningeal metastases
Active, known or suspected autoimmune disease
Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
History of interstitial lung disease or pneumonitis
Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
History of allergy or hypersensitivity to study drug components

Intervenciones

biological

Nivolumab

Specified dose on specified days

drug

Trametinib

Specified dose on specified days

biological

Ipilimumab

Specified dose on specified days

drug

Regorafenib

Specified dose on specified days

Ubicaciones

Local Institution - 0120

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0123

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0122

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0119

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorNovartis

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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