Estado del programa
ReclutamientoFase
Fase 2Inmunoterapia previa permitida
NoEnsayo dirigido por el CRC
SíDrogas
Avelumab, Cetuximab Injection, IrinotecanEtiquetas
MSS/ MMRp| Ubicación | Situación |
|---|---|
| Bélgica | |
|
Cliniques Universitaires Saint-Luc Brussels 1200 |
Reclutamiento |
|
Grand Hôpital de Charleroi Charleroi 6000 |
Reclutamiento |
Contactos
Criterios de inclusión
Criterios de inclusión:
Age 18 and over, Performance status: ECOG 0-1
Histologically proven metastatic colorectal adenocarcinoma, refractory to standard chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan) and anti-EGFR treatment (only for RAS WT tumor)
Measurable disease (RECIST 1.1)
Metastasis accessible for sequential biopsies
Patient consent for metastasis biopsies in the study protocol
BRAF V600E wild-type and MSS tumors
Adequate normal organ and marrow function (see adequate section of the full protocol for definition)
Life expectancy of at least 4 months
Criterios de exclusión
Criterios de exclusión:
Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy that are not indicated in the study protocol
Systemic autoimmune disease,
Chronic treatment with corticoids or other immunosuppressive treatment
Clinically significant cardiac, lung or general disease despite optimal treatment
Non-progressive disease following irinotecan-based treatment.
For RAS WT, non-progressive disease following anti-EGFR treatment.
