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

PHASE3RecruitingINTERVENTIONAL
Enrollment

238

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2029

Conditions
Colorectal Cancer
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

Trial Locations (21)

20132

RECRUITING

Ospedale San Raffaele, Milan

20133

RECRUITING

Fondazione IRCCS INT - Milano, Milan

25124

RECRUITING

Fondazione Poliambulanza, Istituto Ospedaliero, Brescia

29121

RECRUITING

Azienda Usl di Piacenza, Piacenza

33081

RECRUITING

IRCCS Centro di Riferimento Oncologico, Aviano

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale, Udine

35128

RECRUITING

Istituto Oncologico Veneto Irccs, Padua

41124

RECRUITING

Azienda Ospedaliero Universitaria di Modena, Modena

47014

RECRUITING

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola

48121

RECRUITING

Azienda USL della Romagna, Ravenna

50134

RECRUITING

AOU Careggi, Florence

55100

RECRUITING

Ospedale San Luca, Lucca

56126

RECRUITING

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

57124

RECRUITING

Azienda USL Toscana Nord Ovest, Livorno

59100

RECRUITING

Nuovo Ospedale di Prato S. Stefano, Prato

71013

RECRUITING

Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo

73039

RECRUITING

Azienda Ospedaliera Card. G. Panico, Tricase

80131

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli, Naples

95123

RECRUITING

Azienda Ospedaliero Universitaria Policlinico Rodolico - S. Marco, Catania

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

00133

RECRUITING

Policlinico Universitario Tor Vergata, Rome

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Gruppo Oncologico del Nord-Ovest

OTHER