MedTrace Logo

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

NCT04072198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-03-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Nivolumab

240 mg every 2 weeks for 8 cycles followed by maintenance

DRUG

Bevacizumab

5 mg/kg every 2 weeks for 8 cycles followed by maintenance

DRUG

Irinotecan

165 mg/m2 every 2 weeks for 8 cycles

DRUG

Oxaliplatin

85 mg/m2 every 2 weeks for 8 cycles

DRUG

Leucovorin

200 mg/m2 every 2 weeks for 8 cycles

DRUG

fluoruracil

3200mg/m2 every 2 weeks for 8 cycles

Sponsors & Collaborators

  • Gruppo Oncologico Italiano di Ricerca Clinica

    lead OTHER

Principal Investigators

  • Carmine Pinto, MD · Gruppo Oncologico Italiano di Ricerca Clinica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2024-08-30
Completion
2024-10-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072198 on ClinicalTrials.gov