drugset / Trial / NCT03721653
FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The scope of this study is to evaluate the efficacy of the addition of atezolizumab to FOLFOXIRI plus bevacizumab as first line treatment of patients with metastatic colorectal cancer in terms of Progression Free Survival.
Timeline
- Start
- 2018-11-30
- Primary completion
- 2021-06-15
- Completion
- 2023-08-31
Publications
- Antoniotti C, Rossini D, Pietrantonio F, Salvatore L, Lonardi S, Tamberi S, Marmorino F, Moretto R, Prisciandaro M, Tamburini E, Tortora G, Passardi A, Bergamo F, Raimondi A, Ritorto G, Borelli B, Conca V, Ugolini C, Aprile G, Antonuzzo L, Gelsomino F, Martinelli E, Pella N, Masi G, Boni L, Galon J, Cremolini C. Upfront Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan Plus Bevacizumab With or Without Atezolizumab for Patients With Metastatic Colorectal Cancer: Updated and Overall Survival Results of the ATEZOTRIBE Study. J Clin Oncol. 2024 Aug 1;42(22):2637-2644. doi: 10.1200/JCO.23.02728. Epub 2024 Jun 12.
- Antoniotti C, Rossini D, Pietrantonio F, Catteau A, Salvatore L, Lonardi S, Boquet I, Tamberi S, Marmorino F, Moretto R, Ambrosini M, Tamburini E, Tortora G, Passardi A, Bergamo F, Kassambara A, Sbarrato T, Morano F, Ritorto G, Borelli B, Boccaccino A, Conca V, Giordano M, Ugolini C, Fieschi J, Papadopulos A, Massoue C, Aprile G, Antonuzzo L, Gelsomino F, Martinelli E, Pella N, Masi G, Fontanini G, Boni L, Galon J, Cremolini C; GONO Foundation Investigators. Upfront FOLFOXIRI plus bevacizumab with or without atezolizumab in the treatment of patients with metastatic colorectal cancer (AtezoTRIBE): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2022 Jul;23(7):876-887. doi: 10.1016/S1470-2045(22)00274-1. Epub 2022 May 27.
- Antoniotti C, Borelli B, Rossini D, Pietrantonio F, Morano F, Salvatore L, Lonardi S, Marmorino F, Tamberi S, Corallo S, Tortora G, Bergamo F, Brunella DS, Boccaccino A, Grassi E, Racca P, Tamburini E, Aprile G, Moretto R, Boni L, Falcone A, Cremolini C. AtezoTRIBE: a randomised phase II study of FOLFOXIRI plus bevacizumab alone or in combination with atezolizumab as initial therapy for patients with unresectable metastatic colorectal cancer. BMC Cancer. 2020 Jul 22;20(1):683. doi: 10.1186/s12885-020-07169-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 840 mg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 165 mg/m2 | Intravenous |
| Background | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 3200 mg/m2 | — |