Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients

Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Study ID
NCT04072198
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    240 mg every 2 weeks for 8 cycles followed by maintenance
  • Bevacizumab — DRUG
    5 mg/kg every 2 weeks for 8 cycles followed by maintenance
  • Irinotecan — DRUG
    165 mg/m2 every 2 weeks for 8 cycles
  • Oxaliplatin — DRUG
    85 mg/m2 every 2 weeks for 8 cycles
  • Leucovorin — DRUG
    200 mg/m2 every 2 weeks for 8 cycles
  • fluoruracil — DRUG
    3200mg/m2 every 2 weeks for 8 cycles

Study Details

This is a multicentric single arm, open label trial. In this study patients candidated to a first line of chemotherapy for metastatic colorectal cancer will be treated with 8 cycles of folfoxiri plus bevacizumab plus nivolumab followed by a maintenance with bevacizumab plus nivolumab. Patients who do not progress during chemotherapy phase will receive bevacizumab plus nivolumab as maintenance therapy. Patients will be treated until disease progression, unacceptable toxicity or patient/physician decision.

Key Dates

Start date
Sep 26, 2019
Status verified
Mar 2025
Primary completion
Aug 30, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
73 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOXIRI/Bevacizumab + Nivolumab
    Bevacizumab 5 mg/m2 Nivolumab 240 mg Irinotecan 165 mg/m2 iv (max 8 cycles) Oxaliplatin + leucovorin 200 mg/m2 (max 8 cycles) Fluorouracil 3200 mg/m2 (max 8 cycles)

Primary Outcome Measure

ORR [ Time Frame: 36 months ]

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