At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 218 enrolled
Drug / intervention
Bevacizumab +5 moredrug
Likely dose
Bevacizumab 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Study of FOLFOXIRI Plus Bevacizumab Plus Atezolizumab Versus FOLFOXIRI Plus Bevacizumab as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients.
In Brief
A Phase 2 clinical trial evaluating Bevacizumab, Irinotecan, and 4 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 218 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesItaly
CollaboratorsRoche Pharma AG
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionJun 2021
Study CompletionAug 2023
TodayJul 2026
First PostedOct 26, 2018
Enrollment StartNov 30, 2018
Primary CompletionJun 15, 2021
Study CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.7 years ago
Interventions
Bevacizumabdrug
5 mg/kg iv over 30 minutes day 1
Irinotecandrug
165 mg/sqm iv over 60 minutes day 1
Oxaliplatindrug
85 mg/sqm iv over 2 hours day 1
L-Leucovorindrug
200 mg/sqm iv over 2 hours day 1
5-fluorouracildrug
3200 mg/sqm 48 h-continuous infusion
Atezolizumabdrug
840 mg iv over 30 minutes (60 minutes at the first infusion) day 1