NCT04513951

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	5Fluorouracil	phase II
DRUG	L-leucovorin	phase II
DRUG	Irinotecan	phase II
DRUG	Oxaliplatin	phase II
DRUG	Cetuximab	phase II
DRUG	Avelumab	phase II

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-06-28
• Completion: 2024-12-31
• First posted: 2020-08-14
• Last updated: 2025-01-09

Locations

1 site across 1 country: Italy