IMPROVE-2 Trial
Randomized phase 3 study of intermittent or continuous Panitumumab plus FOLFIRI for first-line treatment of patients with left-sided RAS/B-RAF wild-type metastatic colorectal cancer.
The IMPROVE-2 trial is an innovative study exploring a new way to treat metastatic colorectal cancer (mCRC). It compares intermittent versus continuous use of Panitumumab plus chemotherapy (FOLFIRI) in patients with left-sided, RAS/BRAF wild-type mCRC. The goal is to find a balance between treatment effectiveness and quality of life.
Current treatments for mCRC can be effective but often lead to significant side effects and drug resistance. The IMPROVE-2 trial investigates whether taking breaks from Panitumumab (intermittent treatment) is as effective as continuous use while reducing side effects and improving tolerability.
The primary objective of the trial is to determine whether intermittent treatment effectively delays tumour progression in first-line therapy for mCRC. Secondary objectives include assessing whether intermittent treatment improves activity, safety, tolerability, and quality of life compared to continuous treatment. The trial will also aim to identify biomarkers of resistance and monitor treatment efficacy and toxicity using tumour tissue, resected metastases, and blood samples.
The trial will also analyse blood samples over time to better understand how the cancer evolves and responds to treatment. By studying specific biomarkers in the blood, researchers can track how the tumour adapts and whether certain changes might indicate resistance to treatment. This could help personalise future treatment approaches and improve patient outcomes.
This study could provide effective treatment while reducing severe skin reactions and improving quality of life. Additionally, it will explore the use of blood tests to track cancer evolution and create more personalised treatment plans. If successful, the IMPROVE-2 trial could revolutionise treatment strategies for metastatic colorectal cancer, making therapy more effective and manageable for patients worldwide.
Previous Trial: IMPROVE-1
The previous IMPROVE-1 trial (ClinicalTrials.gov identifier: NCT04425239) tested a similar intermittent approach in a phase II setting. It showed that patients who received Panitumumab with planned treatment breaks had fewer side effects while maintaining treatment effectiveness. These promising results provided the foundation for the larger, phase III IMPROVE-2 trial.
For more information about IMPROVE-1, please click here.
