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

NCT06733038 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2025-12-08

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • Carlotta Antoniotti, MD, PhD · Department of Translational Research and New Technologies in Medicine and Surgery - University of Pisa

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
2024-11-15
Primary Completion
2028-04-01
Completion
2029-04-01

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT06733038 on ClinicalTrials.gov