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

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.

Timeline

Start

2019-09-26

Primary completion

2024-08-30

Completion

2024-10-30

Publications

• Damato A, Bergamo F, Antonuzzo L, Nasti G, Iachetta F, Romagnani A, Gervasi E, Larocca M, Pinto C. FOLFOXIRI/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS/BRAF Mutated: Safety Run-In of Phase II NIVACOR Trial. Front Oncol. 2021 Dec 14;11:766500. doi: 10.3389/fonc.2021.766500. eCollection 2021.
• Damato A, Iachetta F, Antonuzzo L, Nasti G, Bergamo F, Bordonaro R, Maiello E, Zaniboni A, Tonini G, Romagnani A, Berselli A, Normanno N, Pinto C. Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated - NIVACOR trial (GOIRC-03-2018). BMC Cancer. 2020 Aug 31;20(1):822. doi: 10.1186/s12885-020-07268-4.

Drugs

Indications