NCT04513951: AVETRIC

AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients

Completed Phase 2 Last updated 9 January 2025

What this trial tests

Phase 2 trial testing 5Fluorouracil in Metastatic Colorectal Cancer in 62 participants. Completed in 31 December 2024.

Timeline

1 April 2020

Primary endpoint
28 June 2023

31 December 2024

Quick facts

Lead sponsor	Gruppo Oncologico del Nord-Ovest
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	1 April 2020
Primary completion	28 June 2023
Estimated completion	31 December 2024
Sites	1 location across Italy

Drugs / interventions tested

• 5Fluorouracil
• L-leucovorin
• Irinotecan (irinotecan) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Cetuximab (cetuximab) — full drug profile →
• Avelumab (avelumab) — 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 aim of this study is to evaluate the efficacy of mFOLFOXIRI plus cetuximab and avelumab as first line treatment of patients with initially unresectable and previously untreated RAS wild-type metastatic colorectal cancer (mCRC), in terms of Progression-free Survival.

Publications & conference data

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

1. Molecular mechanisms targeting drug-resistance and metastasis in colorectal cancer: Updates and beyond.
   Al Bitar S, El-Sabban M, Doughan S, Abou-Kheir W. · · 2023 · cited 53× · PMID 36998426 · DOI 10.3748/wjg.v29.i9.1395
2. Combined Treatment with Immunotherapy-Based Strategies for MSS Metastatic Colorectal Cancer.
   Baraibar I, Mirallas O, Saoudi N, Ros J, et al · · 2021 · cited 44× · PMID 34944931 · DOI 10.3390/cancers13246311
3. Advances in immune checkpoint inhibitor combination strategies for microsatellite stable colorectal cancer.
   Ros J, Balconi F, Baraibar I, Saoudi Gonzalez N, et al · · 2023 · cited 33× · PMID 36816981 · DOI 10.3389/fonc.2023.1112276
4. The role of immunotherapy in microsatellites stable metastatic colorectal cancer: state of the art and future perspectives.
   Gandini A, Puglisi S, Pirrone C, Martelli V, et al · · 2023 · cited 29× · PMID 37207140 · DOI 10.3389/fonc.2023.1161048
5. Immune-Checkpoint Inhibitors for Metastatic Colorectal Cancer: A Systematic Review of Clinical Outcomes.
   Shek D, Akhuba L, Carlino MS, Nagrial A, et al · · 2021 · cited 21× · PMID 34503155 · DOI 10.3390/cancers13174345
6. Current Landscape and Potential Challenges of Immune Checkpoint Inhibitors in Microsatellite Stable Metastatic Colorectal Carcinoma.
   San-Román-Gil M, Torres-Jiménez J, Pozas J, Esteban-Villarrubia J, et al · · 2023 · cited 12× · PMID 36765821 · DOI 10.3390/cancers15030863
7. Immunocheckpoint Inhibitors in Microsatellite-Stable or Proficient Mismatch Repair Metastatic Colorectal Cancer: Are We Entering a New Era?
   Matteucci L, Bittoni A, Gallo G, Ridolfi L, et al · · 2023 · cited 8× · PMID 37958363 · DOI 10.3390/cancers15215189
8. Colorectal Cancer at the Crossroads: The Good, the Bad, and the Future of Platinum-Based Drugs.
   Kee JX, Yau JNN, Kumar Muthuramalingam RP, Wang X, et al · · 2025 · cited 6× · PMID 40985211 · DOI 10.1021/acs.chemrev.5c00041