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

NCT03721653 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2023-10-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2021-06-15
Completion
2023-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721653 on ClinicalTrials.gov