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

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT04513951
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 5Fluorouracil — DRUG
    phase II
  • L-leucovorin — DRUG
    phase II
  • Irinotecan — DRUG
    phase II
  • Oxaliplatin — DRUG
    phase II
  • Cetuximab — DRUG
    phase II
  • Avelumab — DRUG
    phase II

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Jan 2025
Primary completion
Jun 28, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mFOLFOXIRI + Cetuximab + Avelumab
    * Avelumab, 800 mg intravenous \[IV\] dose over 60 minutes, day 1, followed by * Cetuximab, 500 mg/m2 IV dose over 2 hours at cycle 1 (if well tolerated, it is administered over 90 minutes at cycle 2 and over 60 minutes by cycle 3), day 1, followed by * Irinotecan 150 mg/ m2 IV dose over 60 minutes day 1, followed by * Oxaliplatin 85 mg/m2 IV dose over 2 hours, day 1 in two-way with * L-Leucovorin 200 mg/ m2 IV dose over 2 hours, day 1 followed by * 5-fluoruracil 2400 mg/m2 IV dose 48 h-continuous infusion, starting on day 1; to be repeated every 14 days for a maximum of 12 cycles. If no progression occurs during the induction treatment, patients will receive maintenance with 5-FU/LV plus cetuximab and avelumab at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus cetuximab and avelumab will be repeated biweekly until disease progression, unacceptable toxicity, patient's refusal or consent withdrawal.

Primary Outcome Measure

Progression-free Survival [ Time Frame: 19 months ]

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