Personalised Immunotherapy Platform

MELANOMA:

Inclusion Criteria:

1. Written informed consent to participation for the use of tumour tissue, blood andstool and collection of standard clinical data.

2. Histologically confirmed resected stage II (at high risk of recurrence of disease),III or stage IV melanoma (including cutaneous, mucosal, acral, subungual, uveal orunknown 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 surgery and where nosystemic treatments (e.g. adjuvant treatment) were administered between sampleprocurement and proposed PIP testing

5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past areeligible if they have had recurrence after neoadjuvant or adjuvant therapy has beencompleted and the biopsy represents this relapsed disease

6. RECIST version 1.1 measurable disease.

7. Tissue sample must be representative of the whole tumour and therefore excisionbiopsies are preferred over core biopsies.

8. A life expectancy over 6 months.

9. Prior treatment with BRAF (B-Raf proto-oncogene) / MEK (mitogen-activated proteinkinase) 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 thebiomarker test must be from an area that was not within the radiotherapy field.

Exclusion Criteria:

1. Patients will be excluded if they have had a positive test result for hepatitis Bvirus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCVantibody), indicating acute or chronic infection. If receiving treatment and fromHCV for at least one year, patients are allowed to participate. No new testing isrequired for the sole purpose of this pilot phase. Patients will be excluded if theyhave known history of testing positive for human immunodeficiency virus (HIV) orknown acquired immunodeficiency syndrome (AIDS). No new testing is required

NON-MELANOMA:

Inclusion Criteria:

1. Written informed consent to participation for the use of tumour tissue andcollection of standard clinical data

2. Histologically confirmed cancer and eligibility to receive immunotherapy treatment.

3. Availability of a tissue sample where no systemic treatments were administeredbetween sample procurement and proposed PIP testing

4. If treatment has been administered since the last tissue sample was obtained, a newbiopsy should be planned for routine testing or clinical trial screening, where aportion of the sample can be used for the predictive assay. No new biopsies arerequired for the sole purpose of this study.

5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past areeligible if they have had recurrence after neoadjuvant or adjuvant therapy has beencompleted 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 areconsidered measurable if RECIST-defined disease progression since radiotherapyhas 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 excisionbiopsies are preferred over core biopsies.

8. A life expectancy over 6 months.

9. Prior treatment with targeted therapies are acceptable, providing the othereligibility criteria are met.

10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for thebiomarker test must be from an area that was not within the radiotherapy field

Exclusion Criteria:

1. Patients will be excluded if they have had a positive test result for hepatitis Bvirus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCVantibody), indicating acute or chronic infection. If receiving treatment and fromHCV for at least one year, patients are allowed to participate. No new testing isrequired for the sole purpose of this pilot phase. Patients will be excluded if theyhave known history of testing positive for human immunodeficiency virus (HIV) orknown acquired immunodeficiency syndrome (AIDS). No new testing is required