RecruitingPHASE2INTERVENTIONAL

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

This study, called 'Basket of Baskets', aims to find new and more personalised ways to treat advanced cancers when standard treatments are no longer enough. Researchers will first test a patient's tumour for specific genetic changes. Based on these changes, patients will then be offered one of three different study drugs: atezolizumab, futibatinib, or amivantamab. The study is divided into 'modules', with each module testing a different drug. The main goal is to see how effectively these matched treatments can shrink tumours in different groups of patients over a few weeks. This approach hopes to improve treatment by giving patients drugs that are specifically chosen for their cancer's unique genetic fingerprint, regardless of where in the body the cancer started.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Vall d'Hebron Institute of Oncology

Enrolment target

1,000

Start

10 Dec 2018

Estimated completion

01 Nov 2026

Advanced Solid Tumor

What is this study about?

This study is designed to explore a new approach to treating advanced cancers – those that have spread or cannot be removed by surgery. Instead of treating all cancers of a certain type the same way, this study aims to find 'tailored' treatments based on the specific changes or mutations found in a patient's cancer cells. Think of it like this: your cancer might have a unique 'fingerprint', and this study tries to find a drug that specifically targets that fingerprint.

The study involves two main parts. The first part, called iPROFILER, is where doctors will take a sample of your tumour (if you don't already have a recent one available). This sample will be tested to look for specific genetic changes within the cancer cells. These changes often play a role in how the cancer grows. Once these changes are identified, the second part, called iBASKET, might offer you a specific treatment. This is where you might receive one of the study drugs: atezolizumab, futibatinib, or amivantamab, chosen because it's believed to target the specific changes found in your tumour.

The overall goal is to see if these targeted drugs can shrink tumours in groups of patients whose cancers share similar genetic changes, even if their cancers started in different parts of the body. This is a Phase 2 study, which means it’s looking to gather more information on how well these treatments work and if they are safe, after earlier safety tests. The hope is that this kind of personalised approach could lead to more effective treatments for cancer in the future.

Key takeaways

This study explores personalised cancer treatment by matching drugs to tumour gene changes.
It's for advanced solid tumours where standard treatments are no longer working or available.
Participation involves tumour testing (iPROFILER) then potentially receiving one of three study drugs (iBASKET).
The goal is to see if targeted drugs shrink tumours in specific patient groups.
You can withdraw from the study at any time without affecting your standard care.
It's a Phase 2 study focused on how well the treatments work and their safety.

Who may be eligible?

To be considered for this study, you generally need to be an adult (18 years or older) with an advanced solid tumour (cancer) that has spread or cannot be removed by surgery. This means your cancer has either gotten worse on standard treatments, or there aren't any other approved treatments available, or you can't have standard therapy.

Your general health needs to be good enough to participate, as assessed by your doctor, and your body needs to be working within certain healthy ranges (like your blood, kidney, and liver function). A very important part of joining is that the study needs a sample of your tumour tissue to perform the genetic tests. This might involve using a stored sample if available, or in some cases, you might need a new biopsy.

The study will also check that your tumour can be measured and tracked, and that you are willing to follow the study plan. If you need a new biopsy, your doctor will check that it's safe for you to have one, including checking your blood clotting ability.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an advanced solid cancer that has spread or can't be removed by surgery?
Are you generally well enough for treatment, as assessed by your doctor?
Do you have enough tumour tissue available for genetic testing, or could you have a new biopsy?
Are your kidney, liver, and blood functions healthy enough?

Answer every question to see your result.

What does participation involve?

If you join this study, it starts with a screening period where your doctors will check if you're suitable. This includes reviewing your medical history, doing physical exams, and taking blood tests. Importantly, a sample of your tumour will be collected (either from a recent biopsy or a new one) to check for specific gene changes. This initial testing phase is called iPROFILER.

If your tumour has the right genetic changes and you're suitable for one of the treatment 'modules', you would then move into the iBASKET part of the study. You would receive one of the study treatments: atezolizumab (given directly into a vein every 3 weeks), futibatinib (a tablet taken once a day), or amivantamab (given directly into a vein, initially once a week then every 2 weeks). Your treatment will continue as long as your tumour doesn't grow and you don't experience side effects that make it unsafe or uncomfortable to continue.

Throughout the treatment, you will have regular visits to your doctor for physical examinations, blood tests, and scans (like CT scans) to see how the treatment is working and to monitor any side effects. These assessments help doctors understand the drug's effectiveness and safety. The duration of your participation will depend on how you respond to the treatment and the study's overall timeline, but for Module 1, up to 120 people will be treated. The study will carefully monitor your progress and well-being for as long as you are receiving the study drug.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a targeted treatment specifically chosen for your cancer’s genetic makeup, which could be more effective than other options. However, as with any medical treatment, there are potential risks and side effects from the study drugs, which your doctor will discuss with you in detail. There is no guarantee that the treatment will work for you, and it might not be better than existing treatments. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
Deutsches Krebsforschungszentrum (NCT/DKFZ)
Verified postcode
Heidelberg, Germany· Recruiting
Universitätsklinikum Dresden
Verified postcode
Dresden, Germany· Recruiting
Instituto Nazionale dei Tumori di Milano
Verified postcode
Milan, Italy· Recruiting
Nederland Kanker Instituut (NKI)
Verified postcode
Amsterdam, Netherlands· Recruiting
Hospital Vall d'Hebron
Verified postcode
Barcelona, Spain· Recruiting
Karolinska University Hospital Solna
Verified postcode
Stockholm, Sweden· Recruiting
Cancer Research UK Cambridge Centre
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is a 'targeted therapy'?

A targeted therapy is a medicine designed to attack specific weaknesses or changes found in cancer cells, rather than treating all cells in the body, like traditional chemotherapy.

Will I definitely get a treatment if I join the study?

No, not necessarily. The first part of the study tests your tumour. You will only be offered a treatment in the second part if your tumour has specific genetic changes that match one of the study drugs.

What kind of cancers are being studied?

This study is for advanced 'solid tumours', which means cancers that form lumps or masses anywhere in the body, not blood cancers like leukaemia.

How often will I need to visit the hospital?

The frequency of visits will depend on which study drug you might receive. Some are given every 3 weeks, and others require more frequent initial visits. Your doctor will provide a detailed schedule.

Can I continue with my normal activities if I'm on the study?

Many people continue with their daily activities, but this depends on how you feel on the treatment and any potential side effects. Your study team will advise you based on your individual situation.

How to find out more

Marta Carboneras

mcarboneras@vhio.net +34 686 187 838 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.