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* 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.

5Fluorouracil

L-leucovorin

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.

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.

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

Progression-free survival is defined as the time from enrollment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.

Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during the induction and the maintenance phases of treatment.

Objective Response Rate is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the induction and the maintenance phases of treatment. The determination of clinical response will be based on investigator reported measurements. Responses will be evaluated every 8 weeks.

Immuno-related Objective Response Rate is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to immune-modified RECIST criteria, during the induction and the maintenance phases of treatment. The determination of clinical response will be based on investigator reported measurements. Responses will be evaluated every 8 weeks.

Early Objective Response Rate is defined as the percentage of patients, relative to the total of the enrolled subjects, achieving a ≥ 20% decrease in the sum of diameters of RECIST target lesions at week 8 compared to baseline.

Deepness of Response is defined as the relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline.

R0 Resection Rate is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing secondary R0 resection of metastases. Secondary R0 surgery is defined as microscopically margin free complete surgical removal of all residual disease, performed during treatment or after its completion, allowed by tumoral shrinkage and/or disappearance of one or more lesions.

Overall survival is defined as the time from registration to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients	NCT04513951	Metastatic Colo...	5Fluorouracil L-leucovorin Irinotecan Oxaliplatin Cetuximab Avelumab	18 Years - 75 Years	Gruppo Oncologico del Nord-Ovest
AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients	NCT04513951	Metastatic Colo...	5Fluorouracil L-leucovorin Irinotecan Oxaliplatin Cetuximab Avelumab	18 Years - 75 Years	Gruppo Oncologico del Nord-Ovest

Spots Global Cancer Trial Database for modified folfoxiri