Elovie (bevacizumab biosimilar) for metastatic colorectal cancer in Brazil
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
This project will see if the biosimilar bevacizumab Elovie works well and is safe for adults in Brazil with unresectable stage IV metastatic colorectal cancer receiving first-line therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 133 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Libbs Farmacêutica LTDA Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06808685 on ClinicalTrials.gov |
What this trial studies
This observational, multicenter study will collect real-world clinical data from specialized cancer centers in Brazil on adults with unresectable stage IV metastatic colorectal cancer treated with Elovie. Patients will receive standard care determined by their treating physicians and data on effectiveness, safety, demographics, and treatment patterns will be extracted into a study-specific case report form. Eligible participants include adults who started first-line treatment with Elovie or who switched to Elovie and completed at least one cycle, with their records available at participating sites. No experimental interventions are administered and follow-up reflects routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with unresectable stage IV metastatic colorectal cancer receiving first-line treatment with Elovie or who have switched to Elovie and completed at least one cycle, and who can provide informed consent.
Not a fit: Patients who are not being treated with Elovie, who have resectable or earlier-stage disease, who lack adequate medical records at a participating center, or who do not consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If results are favorable, the data could increase confidence in using Elovie for metastatic colorectal cancer in routine Brazilian practice and support broader access.
How similar studies have performed: Regulatory approval for Elovie was supported by pharmacokinetic bioequivalence studies in mRCC and a phase III trial in NSCLC, but dedicated real-world data in metastatic colorectal cancer are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants of both sexes aged 18 years or older at the start of treatment with bevacizumab; * Participants diagnosed with metastatic colorectal cancer, clinical stage IV, unresectable, by clinical definition in medical records, according to the investigator's assessment at the initial consultation and before any type of palliative treatment; * Participants who are undergoing first-line treatment with Elovie and who have completed at least 1 cycle of treatment or participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) but who have currently switched to Elovie and completed at least 1 cycle of treatment with it, and whose data is available at the institution participating in the study; * Participants with the capacity to understand and consent to their participation in the study through the Free and Informed Consent Form Exclusion Criteria: * Participants who use or have used bevacizumab in a manner different from that described in the current version of the Elovie® package insert; * Participants who have been treated with Elovie for a period longer than 12 treatment cycles; * Participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) and have completed more than 2 treatment cycles with it; * Participants with a concomitant diagnosis of another active malignant neoplasm other than metastatic colorectal cancer.
Where this trial is running
São Paulo, São Paulo
- Instituto Dor de Pesquisa E Ensino — São Paulo, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.