NCT06733038

FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.

Phase III Randomized Study of FOLFOXIRI Plus Bevacizumab and Atezolizumab Versus FOLFOXIRI Plus Bevacizumab as First-Line Treatment of Unresectable pMMR and Immunoscore IC-High Metastatic Colorectal Cancer Patients

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (estimated)
• 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 the addition of Atezolizumab to FOLFOXIRI plus bevacizumab as first line treatment of patients with pMMR and Immunoscore IC-high metastatic colorectal cancer in terms of Progression Free Survival (PFS).

Detailed description

This is a prospective, open-label, multicenter phase III randomized trial in which patients with initially unresectable, previously untreated pMMR and Immunoscore IC-high mCRC will be randomized in a 1:1 ratio to receive induction treatment with FOLFOXIRI plus bevacizumab up to 8 cycles followed by maintenance with 5-FU/LV plus bevacizumab until disease progression, unacceptable toxicity or patient's refusal (arm A) or FOLFOXIRI plus bevacizumab plus atezolizumab up to 8 cycles followed by maintenance with 5-FU/LV plus bevacizumab plus atezolizumab until disease progression, unacceptable toxicity or patient's refusal (arm B). Stratification factors will be ECOG Performance Status (0 versus 1, 2), primary tumour location (right versus left/rectum) and liver metastases (yes versus no). The second- and subsequent lines of treatment will be at investigators' choice.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	840 mg iv over 30 minutes (60 minutes at first infusion) day 1
DRUG	Bevacizumab	5 mg/kg iv over 90 minutes at cycle 1 (if well tolerated, it is administered over 60 minutes at cycle 2, and over 30 minutes at cycle 3) day 1
DRUG	Irinotecan (CPT-11)	165 mg/sqm iv over 60 minutes day 1
DRUG	Oxaliplatin	85 mg/sqm iv over 2 hours day 1
DRUG	Leucovorin	200 mg/sqm iv over 2 hours day 1
DRUG	Fluorouracil (5-FU)	3200 mg/sqm 48 h-continuous infusion, starting on day 1

Timeline

• Start date: 2024-11-15
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2024-12-13
• Last updated: 2025-12-08

Locations

24 sites across 1 country: Italy