drugset / Trial / NCT04513951

AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients

NCT04513951

Phase 2 Completed 62 enrolled Gruppo Oncologico del Nord-Ovest
NaSingle-groupOpen-labelTreatment

Summary

The aim of this study is to evaluate the efficacy of mFOLFOXIRI plus cetuximab and avelumab as first line treatment of patients with initially unresectable and previously untreated RAS wild-type metastatic colorectal cancer (mCRC), in terms of Progression-free Survival.

Timeline

Start
2020-04-01
Primary completion
2023-06-28
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 800 mg Intravenous
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Irinotecan Small molecule 150 mg/m2 Intravenous
Subject Levoleucovorin Unknown 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications