This is a non-interventional study to prospectively test a suite of predictive biomarker models of immunotherapy resistance in patients with melanoma, non-melanoma skin cancers and other solid tumours. The study will evaluate the documentation, processes, accuracy and utility of the predictive biomarker model in clinical practice.
Written informed consent to participation for the use of tumour tissue, blood and stool and collection of standard clinical data.
Histologically confirmed resected stage II (at high risk of recurrence of disease), III or stage IV melanoma (including cutaneous, mucosal, acral, subungual, uveal or unknown primary melanoma) and unresectable Stage III or IV melanoma
Eligible to receive immunotherapy
Availability of a melanoma tissue sample which was obtained at surgery and where no systemic treatments (e.g. adjuvant treatment) were administered between sample procurement and proposed PIP testing
Written informed consent to participation for the use of tumour tissue and collection of standard clinical data
Histologically confirmed cancer and eligibility to receive immunotherapy treatment.
Availability of a tissue sample where no systemic treatments were administered between sample procurement and proposed PIP testing
If treatment has been administered since the last tissue sample was obtained, a new biopsy should be planned for routine testing or clinical trial screening, where a portion of the sample can be used for the predictive assay. No new biopsies are required for the sole purpose of this study.
Patients with melanoma, non-melanoma skin cancer, non-melanoma solid tumours eligible for treatment with immunotherapy(ies)
Cohort
Prospective
Predictive model
Other interventionPatient who have not had immunotherapy will have tumour tested using the predictive model. This determines whether patients are likely to respond, or not to respond to immunotherapy. Results of the predictive model will be compared with the actual response to immunotherapy when this has been completed.
Assessment of the accuracy of predictive test results in melanoma
Proportion of correctly predicted responders and non-responders to the immunotherapy treatment decision by the MDT, based on the 6 month progression-free survival (PFS)
Assessment of the inaccuracy of predictive test results
Identification of patient populations for which the predictive model did not predict response (6 month PFS) to immunotherapy
Evaluation of a test request form - completion rate
Proportion of required data completed by the referring clinician
Analysis of potential barriers to complete a test request form
Identification of barriers to completion of the request form
Evaluation of accessible data in medical records for completion of a test request form
Proportion of required data that is readily available in routine patient medical records
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