VICTORIA
Research type
Research Study
Full title
Comparative effectiveness study of real-world control of TRK fusion positive cancer with patients from larotrectinib (Vitrakvi) clinical trials (VICTORIA)
IRAS ID
315022
Contact name
Mark Teo
Contact email
Sponsor organisation
Bayer Healthcare Pharmaceuticals, Inc.
Duration of Study in the UK
0 years, 3 months, 21 days
Research summary
A neurotrophic tyrosine receptor kinase (NTRK) gene fusion is a mutation (change) that occurs when a piece of the chromosome containing a gene called NTRK breaks off and joins with a gene on another chromosome. NTRK gene fusions lead to abnormal proteins called TRK fusion proteins, which may cause cancer cells to grow. Small clinical trials have shown that medication, such as larotrectinib, inhibiting these TRK fusion proteins can result in shrinkage of participants’ cancers and longer survival, with larotrectinib approved in the USA and Europe based on these small trials.
This study aims to better understand the effectiveness of larotrectinib on participant outcomes by comparing participants with NTRK gene fusions from previous larotrectinib clinical trials with real world outcomes of participants with NTRK gene fusions treated with standard of care (treatment that experts agree is appropriate, accepted, and widely used). These real world outcomes will be collected from the American Association for Cancer Research (AACR) GENIE database, the Cardinal study, and review of medical participant records from multiple international centres (including the UK). The Cardinal Health study was a Bayer sponsored retrospective cohort study of participants with NTRK gene fusions in the US.
It is this latter review of medical participants records in the UK which is the focus of this IRAS application.
REC name
London - City & East Research Ethics Committee
REC reference
22/PR/0661
Date of REC Opinion
20 May 2022
REC opinion
Favourable Opinion