NCT06808685

Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie

Real-world Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie in First-line Treatment in Participants With Unresectable Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 133 (estimated)
• Sponsor: Libbs Farmacêutica LTDA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Colorectal cancer is one of the most common tumors and is the second most prevalent cause of cancer death, leading to almost 1 million deaths per year.Elovie is a bevacizumab biosimilar medicine marketed by Libbs Farmacêutica, which had its registration approved by ANVISA in May 2022.At the time of registration a robust evidence package was presented that included, for example, pharmacokinetic bioequivalence studies in patients with metastatic RCC (mRCC) and a phase III study in participants with non-small cell lung cancer .Conducting a real-world study to evaluate the effectiveness and safety of bevacizumab biosimilar Elovie in patients with mCRC is crucial to provide relevant information on how this therapy behaves in real-world clinical conditions in brazilian population.

Detailed description

Observational, multicenter study with real-world data from specialized cancer centers in Brazil. Participants over 18 years of age, of both sexes, with unresectable clinical stage IV metastatic colorectal cancer, who have received Elovie® (bevacizumab biosimilar) at participating centers and who meet the eligibility criteria will be invited to participate. In this study, data on the effectiveness and safety of treatment with Elovie, as well as clinical and demographic characteristics and treatment patterns will be collected. Participants will undergo standard treatment and clinical follow-up as determined by the treating physician. Data collection will be performed by the researcher and the data transcribed into the Case Report Form data collection form designed specifically for the study.

Conditions

• Metastatic Colorectal Cancer

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2025-02-05
• Last updated: 2025-12-16

Locations

1 site across 1 country: Brazil