Personalised Immunotherapy Platform

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMelanoma Institute Australia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Predictive model

Treatment groups

1,000 Participants
are divided into 3 treatment groups

Sponsors and collaborators