A new type of experimental trial - the ‘Basket of Baskets’ trial - has launched in Cambridge to treat patients with different types of cancer with the same targeted therapy.
Whilst their diseases differ, all the patients share a common genetic mutation.
The trial uses a common molecular profiling platform to allocate patients to targeted therapies which are matched to the genetic features of their individual tumours.
The trial, which has just recruited its first patient in Cambridge and is already open in Paris and Barcelona, aims to screen 1,000 patients over two years.
It is the first time leading cancer centres of excellence across 7 countries in Europe have worked together to set up and run a cancer clinical trial as a truly collaborative process to accelerate access to innovative treatments for patients.
The collaboration which is a legal entity called Cancer Core Europe, brings together ground-breaking cancer researchers and clinicians from France, Spain, Italy, Germany, Sweden, the Netherlands and the UK.
“We are excited to have started recruitment in Cambridge to the Basket of Baskets trial, which provides patients with the opportunity to have their tumour tested to see if they might be suitable to take part in a clinical trial of novel therapies”, said Dr Richard Baird, consultant oncologist and principal investigator of the trial in the UK.
Initially the trial is aimed at patients with late stage cancer who have specific genetic mutations that can be targeted with an immunotherapy drug, atezolizumab**, developed by Roche Pharmaceuticals and provided free of charge for this trial.
Once the trial is fully up and running new experimental drugs from other pharmaceutical companies, that target different genetic mutations, will be added to expand the range of targeted treatments on offer to patients.
Cancer Core Europe has established the infrastructure that allows all of the partners in the collaboration to participate in the trial.
The trial is coordinated and led by Vall d'Hebron Institute of Oncology in Barcelona and represents a true collaborative effort across Cancer Core Europe with the responsibilities for different parts of the trial distributed to centres of excellence within the collaboration.
A single molecular tumour panel was established in Cambridge and will be implemented for patients recruited at all of the trial sites, which provides a level of consistency and efficiency for all of the arms of the trial.
All of the tumour biopsies and blood samples from patients recruited from the different European centres are sent to Cambridge for genetic sequencing. The CRUK Cambridge Centre’s Cancer Molecular Diagnostics Lab (CMDL) tests each tumour sample for 350 genetic mutations to find out whether the patient has the particular mutations that are targeted by atezoluzumab.
The sequencing data is then sent to The Netherlands Cancer Institute (NKI) for data processing and analysis. The information is then compiled at the Karolinska Institute for presentation and discussion.
Every week all the European partners discuss, by teleconference, each new patient’s genetic results and decide the best treatment for that patient.
The genetic results and treatment decision are given to patients within two weeks of signing up to the trial.
The first module will evaluate immunotherapy (anti-PD-L1 antibodies) in a number of specific tumour situations such as mutations of the BRCA1 - BRCA2, MLH1, MSH2, MSH6 or PMS2, POLE or POLD1 genes, other mutations of DNA repair genes, and finally in tumours with high mutation rates.
Prof Carlos Caldas, Director of the Breast Cancer Programme at the CRUK Cambridge Centre, and member of the Board of Directors of CCE added: “The BoB is a series of firsts: 1- the first multi-country investigator led early phase trial by Cancer Core Europe; 2- the first time leading European cancer centres across Europe worked together to develop and deploy a multi-gene panel for patient stratification; 3- the first practical example of the uniqueness of the CCE consortium as a collaboration of top European Cancer Centres that in the past used to compete with each other.”