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

Metastatic Colorectal Cancer Clinical Trial

Official title:
Phase II Study of AVELUMAB and CETUXIMAB and Modified FOLFOXIRI as Initial Therapy for RAS Wild-type Unresectable Metastatic Colorectal Cancer Patients

Clinical Trial 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.

Clinical Trial Description

This is a prospective, open-label, multicentric phase II single-arm trial in which patients with initially unresectable and previously untreated RAS wild-type mCRC will receive induction treatment with mFOLFOXIRI plus cetuximab and avelumab up to 12 cycles followed by maintenance with 5-FU/LV plus cetuximab plus avelumab until disease progression, unacceptable toxicity or patient's refusal. The second- and subsequent lines of treatment will be at investigators' choice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04513951
Study type Interventional
Source Gruppo Oncologico del Nord-Ovest
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 1, 2020
Completion date July 31, 2024
View Details
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