NCT03721653: AtezoTRIBE

FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients

Completed Phase 2 Last updated 12 October 2023

What this trial tests

Phase 2 trial testing Bevacizumab in Metastatic Colorectal Cancer in 218 participants. Completed in 31 August 2023.

Timeline

30 November 2018

Primary endpoint
15 June 2021

31 August 2023

Quick facts

Lead sponsor	Gruppo Oncologico del Nord-Ovest
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	218
Start date	30 November 2018
Primary completion	15 June 2021
Estimated completion	31 August 2023
Sites	1 location across Italy

Drugs / interventions tested

• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Irinotecan (irinotecan) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• L-Leucovorin
• 5-fluorouracil
• Atezolizumab (atezolizumab) — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Gruppo Oncologico del Nord-Ovest — full company profile →

Who can join

Adults 18 to 75, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Augmenting Anticancer Immunity Through Combined Targeting of Angiogenic and PD-1/PD-L1 Pathways: Challenges and Opportunities.
   Hack SP, Zhu AX, Wang Y. · · 2020 · cited 223× · PMID 33250900 · DOI 10.3389/fimmu.2020.598877
2. 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.
   Antoniotti C, Rossini D, Pietrantonio F, Catteau A, et al · · 2022 · cited 191× · PMID 35636444 · DOI 10.1016/s1470-2045(22)00274-1
3. PD-1 and PD-L1 inhibitors in cold colorectal cancer: challenges and strategies.
   Lin KX, Istl AC, Quan D, Skaro A, et al · · 2023 · cited 90× · PMID 37831146 · DOI 10.1007/s00262-023-03520-5
4. Immunotherapy in Colorectal Cancer: Current and Future Strategies.
   Ooki A, Shinozaki E, Yamaguchi K. · · 2021 · cited 80× · PMID 33537496 · DOI 10.23922/jarc.2020-064
5. From Immunogenic Cell Death to Immunogenic Modulation: Select Chemotherapy Regimens Induce a Spectrum of Immune-Enhancing Activities in the Tumor Microenvironment.
   Fabian KP, Wolfson B, Hodge JW. · · 2021 · cited 77× · PMID 34497771 · DOI 10.3389/fonc.2021.728018
6. Improving antitumor immunity using antiangiogenic agents: Mechanistic insights, current progress, and clinical challenges.
   Li SJ, Chen JX, Sun ZJ. · · 2021 · cited 63× · PMID 34137513 · DOI 10.1002/cac2.12183
7. 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.
   Antoniotti C, Borelli B, Rossini D, Pietrantonio F, et al · · 2020 · cited 58× · PMID 32698790 · DOI 10.1186/s12885-020-07169-6
8. Anti-PD-1/PD-L1 therapy for colorectal cancer: Clinical implications and future considerations.
   Chen X, Chen LJ, Peng XF, Deng L, et al · · 2024 · cited 48× · PMID 38042137 · DOI 10.1016/j.tranon.2023.101851