NCT03721653

FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients

Randomized Phase II Study of FOLFOXIRI Plus Bevacizumab Plus Atezolizumab Versus FOLFOXIRI Plus Bevacizumab as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The scope of this study is to evaluate the efficacy of the addition of atezolizumab to FOLFOXIRI plus bevacizumab as first line treatment of patients with metastatic colorectal cancer in terms of Progression Free Survival.

Detailed description

This is a prospective, open-label, multicentric phase II randomized in a 1:2 ratio trial in which patients initially unresectable and previously untreated mCRC will receive induction treatment with FOLFOXIRI plus bev up to 8 cycles followed by maintenance with 5-FU/LV plus bev until disease progression, unacceptable toxicity or patient's refusal (arm A) versus FOLFOXIRI plus bev plus atezolizumab up to 8 cycles followed by maintenance with 5-FU/LV plus bev plus atezolizumab until disease progression, unacceptable toxicity or patient's refusal (arm B). If disease progression does not occur during induction, at the treating physician's discretion, the reintroduction after progression of the same induction treatment (up to 8 cycles) according to randomization arm, followed by maintenance until disease progression, unacceptable toxicity or patient's refusal, is recommended. The third- and subsequent lines of treatment will be at investigators' choice.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	5 mg/kg iv over 30 minutes day 1
DRUG	Irinotecan	165 mg/sqm iv over 60 minutes day 1
DRUG	Oxaliplatin	85 mg/sqm iv over 2 hours day 1
DRUG	L-Leucovorin	200 mg/sqm iv over 2 hours day 1
DRUG	5-fluorouracil	3200 mg/sqm 48 h-continuous infusion
DRUG	Atezolizumab	840 mg iv over 30 minutes (60 minutes at the first infusion) day 1

Timeline

• Start date: 2018-11-30
• Primary completion: 2021-06-15
• Completion: 2023-08-31
• First posted: 2018-10-26
• Last updated: 2023-10-12

Locations

1 site across 1 country: Italy