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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGruppo Oncologico del Nord-Ovest

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

238 Participants
are divided into 2 treatment groups

Sponsors and collaborators