Actively Recruiting
FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2025-12-08
238
Participants Needed
24
Research Sites
228 weeks
Total Duration
On this page
Sponsors
G
Gruppo Oncologico del Nord-Ovest
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal cancer diagnosis
- Initially unresectable metastatic colorectal cancer with no prior chemotherapy for metastatic disease
- Proficient mismatch repair (pMMR) status confirmed by certified local lab
- Immunoscore IC-high status confirmed by central lab
- At least one measurable lesion by RECIST 1.1 criteria
- Adequate tumor tissue available (primary or metastatic)
- Age between 18 and 75 years
- ECOG performance status 0 to 2 if younger than 71 years, or 0 if aged 71 to 75 years
- Life expectancy of at least 12 weeks
- Previous adjuvant chemotherapy allowed only if fluoropyrimidine monotherapy and relapse occurred more than 6 months after adjuvant treatment
- Neutrophil count above 1.5 x 10^9/L, platelets above 100 x 10^9/L, hemoglobin above 9 g/dL
- Total bilirubin at or below 1.5 times upper normal limit; AST/ALT below 2.5 times upper normal limit (or 5 times if liver metastases present); alkaline phosphatase below 2.5 times upper normal limit (or 5 times if liver metastases present)
- Creatinine clearance at least 50 mL/min or serum creatinine at or below 1.5 times upper normal limit
- INR or aPTT at or below 1.5 times upper limit for patients not on therapeutic anticoagulation
- Proteinuria less than 2+ on dipstick; if 2+ detected, 24-hour urine collection must show 1 g or less protein
- Women of childbearing potential must have a negative pregnancy test at baseline
- Use of adequate contraception by males with female partners of childbearing potential and by females of childbearing potential during and after study as specified
- Ability and willingness to comply with study protocol
- Signed informed consent
You will not qualify if you...
- Radiotherapy within 4 weeks before study start
- Prior adjuvant oxaliplatin-containing chemotherapy
- Previous treatment with bevacizumab
- Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 agents
- Complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- Untreated brain metastases, spinal cord compression, or primary brain tumors
- History or current central nervous system disease unless adequately treated
- Significant haemoptysis within one month prior to screening
- Active or untreated CNS metastases
- Symptomatic peripheral neuropathy grade greater than 2
- Serious non-healing wounds, ulcers, or bone fractures
- Bleeding disorders or coagulopathy
- Uncontrolled hypertension or history of hypertensive crisis or encephalopathy
- Significant cardiovascular disease including recent stroke, heart attack, unstable angina, heart failure, or serious arrhythmia
- Significant vascular disease requiring recent surgery or with recent arterial thrombosis
- Active infection needing antibiotics at treatment start
- Previous severe venous thromboembolism
- Recent history of abdominal fistula, gastrointestinal perforation, abscess, or bleeding
- Current or recent full-dose anticoagulant treatment for therapeutic purposes
- Chronic high-dose aspirin use over 325 mg/day
- Use of investigational drugs within 30 days or twice the half-life of prior agents
- Other cancers within last 5 years except certain skin or cervical cancers
- Recent major surgery, open biopsy, or major injury within 28 days
- Minor surgical procedure within 7 days before treatment
- Problems with upper gastrointestinal tract or inability to take oral medication
- Pregnant or breastfeeding women; positive or missing pregnancy test for women of childbearing potential
- History of autoimmune diseases
- History or evidence of certain lung diseases or active pneumonitis
- Positive HIV test
- Active hepatitis B or C infection
- Active tuberculosis
- Prior allogenic bone marrow or solid organ transplant
- Recent systemic immunosuppressive treatment or requirement during trial
- Allergy to study drug components
- Recent live attenuated vaccine administration or planned during study
- Recent treatment with systemic immunostimulatory agents
- Unwillingness to adopt alternative treatments if receiving RANKL inhibitors during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Fondazione Poliambulanza, Istituto Ospedaliero
Brescia, BS, Italy, 25124
Actively Recruiting
2
Azienda Ospedaliero Universitaria Policlinico Rodolico - S. Marco
Catania, CT, Italy, 95123
Actively Recruiting
3
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, FC, Italy, 47014
Actively Recruiting
4
Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy, 71013
Actively Recruiting
5
AOU Careggi
Florence, FI, Italy, 50134
Actively Recruiting
6
Azienda Ospedaliera Card. G. Panico
Tricase, LE, Italy, 73039
Actively Recruiting
7
Azienda USL Toscana Nord Ovest
Livorno, LI, Italy, 57124
Actively Recruiting
8
Ospedale San Luca
Lucca, LU, Italy, 55100
Actively Recruiting
9
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122
Actively Recruiting
10
Ospedale San Raffaele
Milan, MI, Italy, 20132
Actively Recruiting
11
Fondazione IRCCS INT - Milano
Milan, MI, Italy, 20133
Actively Recruiting
12
Azienda Ospedaliero Universitaria di Modena
Modena, MO, Italy, 41124
Actively Recruiting
13
Istituto Oncologico Veneto Irccs
Padova, PD, Italy, 35128
Actively Recruiting
14
IRCCS Centro di Riferimento Oncologico
Aviano, PN, Italy, 33081
Actively Recruiting
15
Nuovo Ospedale di Prato S. Stefano
Prato, PO, Italy, 59100
Actively Recruiting
16
Azienda USL della Romagna
Ravenna, RA, Italy, 48121
Actively Recruiting
17
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy, 00168
Actively Recruiting
18
Azienda Sanitaria Universitaria Friuli Centrale
Udine, UD, Italy, 33100
Actively Recruiting
19
ASL di Viterbo
Viterbo, VT, Italy, 01100
Actively Recruiting
20
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
21
IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"
Naples, Italy, 80131
Actively Recruiting
22
Azienda Usl di Piacenza
Piacenza, Italy, 29121
Actively Recruiting
23
U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa
Pisa, Italy, 56126
Actively Recruiting
24
Policlinico Universitario Tor Vergata
Rome, Italy, 00133
Actively Recruiting
Research Team
C
Carlotta Antoniotti, MD, PhD
CONTACT
L
Laura Delliponti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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