Personalised Immunotherapy Platform (PIP-PREDICT)

• Other: Predictive model

Inclusion Criteria:

MELANOMA

1. Written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. to participation for the use of tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function, bloodthe red bodily fluid that transports oxygen and other nutrients around the body and stoolwaste product from the bowel sent to the anus for removal; also known as faeces or poo and collection of standard clinical data.
2. Histologically confirmed resected stage II (at high riskthe possibility that something bad will happen of recurrenceto occur or happen again of disease), III or stage IV melanoma (including cutaneous, mucosal, acral, subungual, uveal or unknown primary melanoma) and unresectable Stage III or IV melanoma
3. Eligible to receive immunotherapy
4. Availability of a melanoma tissue sample which was obtained at surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence and where no systemic treatments (e.g. adjuvant treatment) were administered between sample procurement and proposed PIP testing
5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsyremoval of a section of tissue to analyse for cancer cells represents this relapsed disease
6. RECIST version 1.1 measurable disease.
7. Tissue sample must be representative of the whole tumour and therefore excisionto surgically remove/cut out biopsies are preferred over core biopsies.
8. A life expectancy over 6 months.
9. Prior treatment with BRAF (B-Raf proto-oncogenea type of gene that normally regulates cell growth and division, but when mutated can cause uncontrollable cell growth and may lead to cancer) / MEK (mitogen-activated protein kinase) inhibitors are acceptable, providing the other eligibility criteria are met.
10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field.

NON-MELANOMA

1. Written informed consent to participation for the use of tumour tissue and collection of standard clinical data
2. Histologically confirmed cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs and eligibility to receive immunotherapy treatment.
3. Availability of a tissue sample where no systemic treatments were administered between sample procurement and proposed PIP testing
4. If treatment has been administered since the last tissue sample was obtained, a new biopsy should be planned for routine testing or clinical trial screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.
5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease.
6. Have clinically detectable disease defined as one of more of the following:
   • RECIST measurable. Lesions situated in a previously irradiated area are considered measurable if RECIST-defined disease progression since radiotherapy has been demonstrated in such lesions, OR,
   • Positron Emission Tomography (PET) avid, OR,
   • Clinically evident disease: photographically, detectable on CT or palpable, OR
   • Clinical status measured by observable and diagnosable signs or symptoms.
7. The tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.
8. A life expectancy over 6 months.
9. Prior treatment with targeted therapies are acceptable, providing the other eligibility criteria are met.
10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field