Personalised Immunotherapy Platform

NCT06536257 | Recruiting

• 1 other identifier: MIA2020/283
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Melanoma; Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma; Merkel Cell Carcinoma; Solid Tumor

Keywords

Biomarker; Predictive; Immunotherapy; Multi-omic; Tumour mutation burden; Gene expression; Tissue imaging; Machine learning; Multiplex immunofluorescence; Immune checkpoint inhibitors; Quantitative pathology

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (24)

• Assessment of the inaccuracy of predictive test results

  6 months

• Evaluation of a test request form - completion rate

  2 years

• Analysis of potential barriers to complete a test request form

  2 years

• Evaluation of accessible data in medical records for completion of a test request form

  2 years

• Evaluation of a test request form from clinician feedback via qualitative surveys

  2 years

Study Arms (3)

Melanoma cohort

Patients with melanoma who are yet to receive immunotherapy will undergo predictive biomarker testing and biomarker reporting.

Other: Predictive model

Non-melanoma skin cancer cohort

Patients with non-melanoma skin cancers (basal cell carcinoma, Merkel cell carcinoma, cutaneous squamous cell carcinoma) who are yet to receive immunotherapy will have tumour tested using the predictive model.

Other: Predictive model

Solid tumour cohort

Patients with non-melanoma, non-skin cancer, solid tumours who are yet to receive immunotherapy will have tumour tested using the predictive model.

Other: Predictive model

Interventions

Predictive model OTHER

Patient 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.

Melanoma cohort; Non-melanoma skin cancer cohort; Solid tumour cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with melanoma, non-melanoma skin cancer, non-melanoma solid tumours eligible for treatment with immunotherapy(ies)

You may qualify if:

• 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
• 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
• RECIST version 1.1 measurable disease.
• Tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.
• A life expectancy over 6 months.
• Prior treatment with BRAF (B-Raf proto-oncogene) / MEK (mitogen-activated protein kinase) inhibitors are acceptable, providing the other eligibility criteria are met.
• 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.

You may not qualify if:

• \. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required
• NON-MELANOMA:
• 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 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.
• 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.
• The tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.
• A life expectancy over 6 months.
• Prior treatment with targeted therapies are acceptable, providing the other eligibility criteria are met.

Sponsors & Collaborators

• Melanoma Institute Australia: lead

Study Sites (3)

Chris O'Brien Lifehouse

Sydney, New South Wales, 2050, Australia

RECRUITING

Melanoma Institute Australia

Sydney, New South Wales, 2065, Australia

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Related Publications (3)

• Gide TN, Paver EC, Yaseen Z, Maher N, Adegoke N, Menzies AM, Pires da Silva I, Wilmott JS, Long GV, Scolyer RA. Lag-3 expression and clinical outcomes in metastatic melanoma patients treated with combination anti-lag-3 + anti-PD-1-based immunotherapies. Oncoimmunology. 2023 Oct 4;12(1):2261248. doi: 10.1080/2162402X.2023.2261248. eCollection 2023.

  PMID: 37808404 BACKGROUND

• Mao Y, Gide TN, Adegoke NA, Quek C, Maher N, Potter A, Patrick E, Saw RPM, Thompson JF, Spillane AJ, Shannon KF, Carlino MS, Lo SN, Menzies AM, da Silva IP, Long GV, Scolyer RA, Wilmott JS. Cross-platform comparison of immune signatures in immunotherapy-treated patients with advanced melanoma using a rank-based scoring approach. J Transl Med. 2023 Apr 13;21(1):257. doi: 10.1186/s12967-023-04092-9.

  PMID: 37055772 RESULT

• Adegoke NA, Gide TN, Mao Y, Quek C, Patrick E, Carlino MS, Lo SN, Menzies AM, Pires da Silva I, Vergara IA, Long G, Scolyer RA, Wilmott JS. Classification of the tumor immune microenvironment and associations with outcomes in patients with metastatic melanoma treated with immunotherapies. J Immunother Cancer. 2023 Oct;11(10):e007144. doi: 10.1136/jitc-2023-007144.

  PMID: 37865395 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Laboratory analysis of pretreatment tumour biopsies: * Tumour mutation burden (TMB): Qiaseq TMB IO (Qaigen) and TruSight Oncology 500 (Illumina) * Gene expression profiling (GEP): Pancancer 360 IO (Nanostring) and Whole Transcriptome Sequencing (Illumina) * Tumour Immune Profiling (mIHC): Multiplex immunohistochemistry (Akoya Biosciences)

MeSH Terms

Conditions

Melanoma; Carcinoma, Basal Cell; Carcinoma, Merkel Cell

Interventions

Predictive Learning Models

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma

Intervention Hierarchy (Ancestors)

Prediction Methods, Machine; Artificial Intelligence; Algorithms; Mathematical Concepts

Study Officials

• James Wilmott, PhD

  Melanoma Institute Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Personalised Immunotherapy Program Manager

CONTACT

+61 2 9911 7200; PIP@melanoma.org.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: August 2, 2024
• Study Start: June 8, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2037
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)