Resumen del Estudio
Este estudio de investigación busca evaluar nuevas opciones de tratamiento para pacientes con cáncer colorrectal localmente avanzado o metastásico (mCRC) que no puede ser operado y que presenta una mutación genética específica llamada KRAS G12C. Actualmente, el tratamiento estándar incluye quimioterapia (mFOLFOX6) combinada a menudo con bevacizumab. Los investigadores quieren determinar si añadir un nuevo medicamento oral llamado MK-1084 junto con cetuximab (una terapia dirigida) a la quimioterapia estándar es seguro y más eficaz. El objetivo principal es ver si esta nueva combinación ayuda a los pacientes a vivir más tiempo sin que el cáncer crezca o se extienda, comparado con el tratamiento habitual.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar: Personas con diagnóstico confirmado de adenocarcinoma colorrectal localmente avanzado o metastásico (Estadio III inoperable o IV) que tengan la mutación KRAS G12C en el tejido tumoral. Para la Parte 2 del estudio, no deben haber recibido quimioterapia sistémica previa para esta etapa de la enfermedad. No pueden participar: Personas con enfermedad inflamatoria intestinal activa (Crohn, colitis ulcerosa), problemas cardiovasculares graves no controlados, deficiencia de DPD conocida, metástasis cerebrales activas o infecciones graves que requieran tratamiento sistémico.
- Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer \[AJCC\] eighth edition) colorectal adenocarcinoma
- Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
- Tumor tissue demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has known dihydropyrimidine dehydrogenase (DPD) deficiency
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
- Has active infection requiring systemic therapy
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease