A clinical trial to understand how genetic testing can help doctors to decide which treatment is best for patients with solid tumours (TAPISTRY)

How does the TAPISTRY clinical trial work?

This clinical trial is recruiting people who have advanced solid tumours that cannot be surgically removed. You must have had genetic testing on your solid tumour that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.

The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumours showing specific biomarkers, which cannot be surgically removed.

How do I take part in this clinical trial?

To be able to take part in this clinical trial, you must have been diagnosed with an advanced solid tumour that has grown or spread, cannot be removed completely with surgery and shows one of the specific biomarkers being tested in this clinical trial:

• ROS1 fusion-positive tumours (excluding non-small cell lung cancer [NSCLC])
• NTRK1/2/3 fusion-positive tumours 
• ALK fusion-positive tumours (excluding NSCLC)
• TMB-high tumours
• AKT1/2/3 mutant-positive tumours
• HER2 mutant-positive tumours
• PIK3CA multiple mutant-positive tumours
• BRAF class II mutant/fusion-positive tumours
• BRAF class III mutant-positive tumours
• RET fusion-positive tumours (excluding NSCLC)

Your doctor will be able to give you more information on the type of biomarker your solid tumour shows.

You must be in otherwise good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.

If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, they may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

Your doctor will conduct some tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

Before starting the clinical trial, you will be told about any risks and benefits of participating in the trial. You will also be told what other treatments are available so that you may decide if you still want to participate.

While taking part in the clinical trial, you will need to either not have heterosexual intercourse or use contraception for safety reasons.

What treatment will I be given if I join this clinical trial?

If you join this clinical trial, you will be entered into one of ten groups, depending on which biomarker your solid tumour has:

• Group A: People with ROS1 fusion-positive tumours (excluding NSCLC). You will receive entrectinib as capsules to take by mouth with or without food every day for as long as it can help you
• Group B: People with NTRK1/2/3 fusion-positive tumours. You will receive entrectinib as capsules to take by mouth with or without food every day, for as long as it can help you
• Group C: People with ALK fusion-positive tumours (excluding NSCLC). You will receive alectinib as capsules to take by mouth with food twice a day, for as long as it can help you
• Group D: People with TMB-high tumours. You will receive atezolizumab as an infusion into the vein once every three weeks, for as long as it can help you
• Group E: People with AKT1/2/3 mutant-positive tumours. You will receive ipatasertib as a tablet to take by mouth with fluid, with or without food once a day, for as long as it can help you
• Group F: People with HER2 mutant-positive tumours. You will receive trastuzumab emtansine as an infusion into the vein once every three weeks, for as long as it can help you
• Group H: People with PIK3CA multiple mutant-positive tumours. You will receive GDC-0077 (inavolisib) as a tablet to take by mouth once a day, for as long as it can help you
• Group I: People with BRAF class II mutant/fusion-positive tumours. You will receive belvarafenib as tablets to take by mouth with water twice a day within 30 minutes of a meal, for as long as it can help you
• Group J: People with BRAF class III mutant-positive tumours. You will receive belvarafenib as tablets to take by mouth with water twice a day within 30 minutes of a meal, for as long as it can help you
• Group K: People with RET fusion-positive tumours (excluding NSCLC). You will receive pralsetinib as capsules to take by mouth with water once a day without food, for as long as it can help you

This clinical trial is ‘open-label’, which means that everyone involved will know which group they are in and what treatment they are receiving.

Group G (people with MDM2-amplified TP53 wild-type tumours) has been closed for enrollment – no patients were enrolled in this cohort.

How often will I be seen in follow-up appointments and for how long?

You will be given the clinical trial treatment for as long as it can help you. During the clinical trial, you will need to attend regular visits for treatments and assessments to see how you are responding to the treatment and any side effects that you may be having. You are free to stop this treatment at any time. After you have finished treatment, the clinical trial staff will still follow up with you approximately every three months, as long as you agree with it.

What happens if I am unable to take part in this clinical trial?

If this clinical trial is not suitable for you, you will not be able to take part. Your doctor may suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04589845

Trial-identifier: NCT04589845