DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations
Trial Parameters
Brief Summary
This clinical trial is looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Capmatinib works in patients with lung cancer with a particular mutation in their cancer known as a METex14 skipping mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
Eligibility Criteria
THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB) OUTLINED BELOW\* \*When capmatinib-specific inclusion/exclusion criteria or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence. Inclusion criteria: A. Confirmed diagnosis of a MET-positive malignancy using an analytically next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation). B. Adult patients ≥18 years old. C. Women of childbearing potential are eligible, provided that they meet the following criteria: * Have a negative serum or urine pregnancy test before enrolment, and * Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \<1% when used consistently and correctly), such as: I. combined (oestrogen and progestogen containing) hormonal contraception associated