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RecruitingPhase 3NCT06733038

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

Sponsor

Gruppo Oncologico del Nord-Ovest

Enrollment

238 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding atezolizumab (an immunotherapy) to a standard intensive chemotherapy + bevacizumab combination (FOLFOXIRI plus bevacizumab) as a first-line treatment improves outcomes in people with metastatic colorectal cancer that has a specific immune profile (pMMR/Immunoscore IC-high). **You may be eligible if...** - You are 18–75 years old - You have confirmed colorectal cancer that has spread (metastatic) and cannot be surgically removed right now - You have not received prior chemotherapy for metastatic disease - Your tumor is classified as pMMR (proficient mismatch repair) and Immunoscore IC-high (specific immune markers) - You have at least one measurable tumor on imaging - You are in adequate overall health **You may NOT be eligible if...** - You have already received chemotherapy for metastatic colorectal cancer - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding - You have active, untreated brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

840 mg iv over 30 minutes (60 minutes at first infusion) day 1

DRUGBevacizumab

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

DRUGIrinotecan (CPT-11)

165 mg/sqm iv over 60 minutes day 1

DRUGOxaliplatin

85 mg/sqm iv over 2 hours day 1

DRUGLeucovorin

200 mg/sqm iv over 2 hours day 1

DRUGFluorouracil (5-FU)

3200 mg/sqm 48 h-continuous infusion, starting on day 1

Locations(24)

Fondazione Poliambulanza, Istituto Ospedaliero

Brescia, BS, Italy

Azienda Ospedaliero Universitaria Policlinico Rodolico - S. Marco

Catania, CT, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola, FC, Italy

Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, Italy

AOU Careggi

Florence, FI, Italy

Azienda Ospedaliera Card. G. Panico

Tricase, LE, Italy

Azienda USL Toscana Nord Ovest

Livorno, LI, Italy

Ospedale San Luca

Lucca, LU, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Ospedale San Raffaele

Milan, MI, Italy

Fondazione IRCCS INT - Milano

Milan, MI, Italy

Azienda Ospedaliero Universitaria di Modena

Modena, MO, Italy

Istituto Oncologico Veneto Irccs

Padova, PD, Italy

IRCCS Centro di Riferimento Oncologico

Aviano, PN, Italy

Nuovo Ospedale di Prato S. Stefano

Prato, PO, Italy

Azienda USL della Romagna

Ravenna, RA, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, UD, Italy

ASL di Viterbo

Viterbo, VT, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, Italy

IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"

Naples, Italy

Azienda Usl di Piacenza

Piacenza, Italy

U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa

Pisa, Italy

Policlinico Universitario Tor Vergata

Rome, Italy

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NCT06733038

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