About this trial
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 criteria
Qualifiers
Histologically proven diagnosis of colorectal cancer;
Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
Proficient mismatch repair (pMMR) status in tumour tissue (primary or metastatic), as determined by a local laboratory assay in a CLIA- or similarly certified;
Immunoscore IC-high status in tumour tissue (primary or metastatic), as determined by a sponsor-defined central laboratory (HEGP, AP-HP, INSERM, France).
Disqualifiers
Radiotherapy to any site within 4 weeks before the study;
Previous adjuvant oxaliplatin-containing chemotherapy;
Previous treatment with bevacizumab;
Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents;
Trial design
Treatments tested in this trial
- Atezolizumab
- Bevacizumab
- Irinotecan (CPT-11)
- Oxaliplatin
- Leucovorin
- Fluorouracil (5-FU)
Treatment groups
Sponsors and collaborators
Gruppo Oncologico del Nord-Ovest
Lead sponsor
Hoffmann-La Roche
Collaborator