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

NCT06808685 | Recruiting

• 1 other identifier: LB2401
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

Elovie; bevacizumab; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of treatment with bevacizumab

  Median duration in months and number of cycles of first-line treatment until the switch to second-line treatment, for any reason, through the collection of electronic medical record data.

  24 months

Secondary Outcomes (6)

• progression-free survival

  24 months

• Overall survival

  24 months

• The survival rate

  24 months

• Objective Response Rate

  24 months

• Functional capacity

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants of both sexes 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

Study Sites (1)

Instituto Dor de Pesquisa E Ensino

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

BR (1)