RELEVANCE
Research type
Research Study
Full title
REal-LifE eVAluation of genomic biomarkers of clinical benefit from immunotherapy in advaNCEd cancer patients: the RELEVANCE study.
IRAS ID
333594
Contact name
Simon Pacey
Contact email
Sponsor organisation
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano on behalf of Cancer Core Europe (CCE)
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
This is a multicentre, retrospective-prospective, observational, international study aimed at identifying the clinical benefit of immunotherapy-based treatments, as used as any line of therapy for advanced disease, in cancer patients with advanced solid tumours bearing at least one of the six following genomic alterations in DNA repair pathways:
- BRCA1 or BRCA2 pathogenic mutations/deletions;
- MLH1, MSH2, MSH6, or PMS2 mutations (MSI);
- Inactivating POLE or POLD1 mutations;
- Hypermutated tumors (high or intermediated tumor mutational load);
- Mutations in other DNA repair genes involved in the Homologous Recombination pathway;
- CD274 gene amplification
(Key: BRCA = Breast cancer gene; MLH1/MSH2/MSH6/PMS2 = DNA repair genes; MSI = Microsatellite instability; POLE/POLD1/CD274 = Protein coding genes)
The study will evaluate the impact of these tumor genomic alterations on the efficacy of Standard of Care (SoC) immunotherapies or immunotherapy-based combinations used in real-life clinical practice, i.e., in patients who are candidates to receive immunotherapy in the context of standard anti-cancer treatments.
The results of this study will also be used to contextualise the results from the Basket of Baskets (BoB) trial Module 1. Patients enrolled in BoB Module 1 are selected by the presence of one of the six genomic alterations but differ significantly e.g. in tumour type, stage or previous treatments.
Approximately 1400 patients will be included across several specialist oncology centres in the UK and Europe.REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0101
Date of REC Opinion
26 Mar 2025
REC opinion
Favourable Opinion