Personalised Immunotherapy Platform
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 clinic
| Condition(s) | Melanoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Merkel Cell Carcinoma, Solid Tumor |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | MELANOMA: Inclusion Criteria: 1. Written informed consent to participation for the use of tumour tissue, blood and stool 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 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 surgery 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 thera |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Melanoma Institute Australia |
| Locations | Sydney, New South Wales, Australia; Sydney, New South Wales, Australia; Sydney, New South Wales, Australia |
| Start date | 2021-06-08 |
| NCT ID | NCT06536257 |
| Official listing | https://clinicaltrials.gov/study/NCT06536257 |