A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07284849Tipo: INTERVENTIONALInicio: 5 de mar de 2026Fin estimado: 28 de sept de 2029

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Stage IV colorectal adenocarcinoma not amenable to curative resection.
No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
Measurable disease per RECIST v1.1.
ECOG performance status of 0 or 1.
Adequate organ function determined by laboratory results.

Criterios de exclusión

MSI-H/dMMR per historical data in the medical record.
BRAF V600E mutation per historical data in the medical record.
Untreated and/or progressing CNS metastases.
History of other malignancy within 2 years.
Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
Active autoimmune disease that has required systemic treatment in the past 2 years.
Significant concurrent and/or uncontrolled medical condition.
History of organ transplant, including allogeneic stem cell transplantation.

Intervenciones

drug

INCA33890

INCA33890 will be administered at protocol defined dose.

drug

Placebo

Placebo will be administered at protocol defined dose.

drug

Bevacizumab

Bevacizumab will be administered at protocol defined dose.

drug

FOLFOX

FOLFOX will be administered at protocol defined dose.

Ubicaciones

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

NOT_YET_RECRUITING

Investigaciones Clinicas Moleculares Icm

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto Medico Especializado Alexander Fleming

Buenos Aires, Argentina

NOT_YET_RECRUITING

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto de Investigaciones Clinicas Cordoba S.A.

Córdoba, Argentina

NOT_YET_RECRUITING

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, Argentina

NOT_YET_RECRUITING

Centro Oncologico Riojano Integral (Cori)

La Rioja, Argentina

NOT_YET_RECRUITING

Investigaciones Oncologicas C Colon

Mar del Plata, Argentina

NOT_YET_RECRUITING

Instituto de Oncologia de Rosario

Rosario, Argentina

NOT_YET_RECRUITING

Exelsus Srl

San Miguel de Tucumán, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalIncyte Corporation

Contactos

Incyte Corporation Call Center (US)

CONTACT

medinfo@incyte.com 1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

eumedinfo@incyte.com +800 00027423

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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