Studies biosimilar bevacizumab Elovie in first-line metastatic colorectal cancer
Observes how the bevacizumab copy Elovie works in adults with spreading colorectal cancer.
Plain-language title generated from the registry record
Registry title: Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
Key facts
- Where
- Campinas, Curitiba, Jaraguá do Sul, Londrina, Porto Alegre, Recife, Santo Ângelo, São Caetano do Sul, São José dos Campos, São Paulo, Teresina, and Vitória, BrazilSee the 14 sites
Where in Brazil
- Hospital Vera CruzCampinas, BrazilTaking people
- Centro de Oncologia do Paraná (COP)Curitiba, BrazilTaking people
- OncoJaraguáJaraguá do Sul, BrazilTaking people
- Centro de Pesquisa Unimed LondrinaLondrina, BrazilTaking people
- Associacao Hospitalar Moinhos de VentoPorto Alegre, BrazilTaking people
- Centro de Pesquisa Unimed Porto AlegrePorto Alegre, BrazilTaking people
- Instituto Dor de Pesquisa E EnsinoRecife, BrazilTaking people
- Unidade de Ensino e Pesquisa UEP-COHMSanto Ângelo, BrazilTaking people
- CEON PesquisasSão Caetano do Sul, BrazilTaking people
- COE Ensino e PesquisaSão José dos Campos, BrazilTaking people
- Centro Paulista de OncologiaSão Paulo, BrazilTaking people
- Instituto Dor de Pesquisa E EnsinoSão Paulo, BrazilTaking people
- Centro de Ensino e Pesquisa - Hospital São MarcosTeresina, BrazilTaking people
- Unimed VitóriaVitória, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Libbs Farmacêutica LTDA
- Trial code
- NCT06808685
- Record updated
- 1 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.