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

Not yet recruiting

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT06808685
• Lead Sponsor: Libbs Farmacêutica LTDA

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.

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-04-24
• Primary Completion: 2027-04-24
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 133

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
• 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
• 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 are or have used bevacizumab in a manner other than that described in the package insert
• Participants who have been treated with Elovie for a period longer than 6 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 this

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of treatment with bevacizumab	24 months	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.

Secondary Outcome Measures

Name	Time	Method
progression-free survival	24 months	progression-free survival will be defined as the median time (in months) from the first dose of bevacizumab to disease progression
Overall survival	24 months	Overall survival will be defined as the median time (in months) from the first dose of bevacizumab until the occurrence of death, from any cause, during the 24-month follow-up period
The survival rate	24 months	The survival rate will be defined as the number and proportion of participants who remained alive after 24 months of follow-up
Objective Response Rate	24 months	The Objective Response Rate will be defined as the number and percentage of participants who had a Complete Response or Partial Response, using the usual methodology of the research center, during 24 months of follow-up after the start of bevacizumab use. The number and percentage of participants who had Stable Disease or Disease Progression will also be evaluated.
Functional capacity	24 months	Functional capacity will be assessed using the ECOG (Eastern cooperative oncology group) scale during 24 months of follow-up after starting bevacizumab.; Scale ECOG Grade 0 - Fully active, able to carry on all pre disease performance without restriction Grade 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5 - Dead https://ecog-acrin.org/resources/ecog-performance-status/
Safety assessment	24 months	To assess the occurrence of adverse events in the 24-month follow-up period since the first dose of Elovie.Assess the median duration of treatment through time in months and number of cycles until switching to another treatment other than the first line, for reasons of toxicity (adverse event).