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

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT06733038
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    840 mg iv over 30 minutes (60 minutes at first infusion) day 1
  • Bevacizumab — DRUG
    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
  • Irinotecan (CPT-11) — DRUG
    165 mg/sqm iv over 60 minutes day 1
  • Oxaliplatin — DRUG
    85 mg/sqm iv over 2 hours day 1
  • Leucovorin — DRUG
    200 mg/sqm iv over 2 hours day 1
  • Fluorouracil (5-FU) — DRUG
    3200 mg/sqm 48 h-continuous infusion, starting on day 1

Study Details

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).

Key Dates

Start date
Nov 15, 2024
Status verified
Dec 2025
Primary completion
Apr 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
238 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A - FOLFOXIRI plus bevacizumab
    Every 2 weeks for a maximum of 8 cycles: * Bevacizumab 5 mg/kg iv 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, followed by * Irinotecan 165 mg/sqm iv over 60 minutes day 1, followed by * Oxaliplatin 85 mg/sqm iv over 2 hours day 1, in two-way with * L-Leucovorin 200 mg/sqm iv over 2 hours day 1, followed by * 5-fluorouracil 3200 mg/sqm 48 h-continuous infusion, starting on day 1. If no progression occurs during FOLFOXIRI plus bev, patients will receive maintenance 5-FU/LV plus bev at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus bev will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal.
  • Experimental: Arm B - FOLFOXIRI plus bevacizumab plus atezolizumab
    Every 2 weeks for a maximum of 8 cycles: * Atezolizumab 840 mg iv over 30 minutes (60 minutes at first infusion) day 1 followed by * 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 followed by * Irinotecan 165 mg/sqm iv over 60 minutes day 1, followed by * Oxaliplatin 85 mg/sqm iv over 2 hours day 1, in two-way with * L-Leucovorin 200 mg/sqm iv over 2 hours day 1, followed by * 5-fluorouracil 3200 mg/sqm 48 h-continuous infusion, starting on day 1. If no progression occurs during FOLFOXIRI plus bev plus atezolizumab, patients will receive maintenance 5-FU/LV plus bev plus atezolizumab at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus bev plus atezolizumab will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 24 months ]

Central Contacts

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