MelanomaPIP-PREDICTNCT06536257
Personalised Immunotherapy Platform
An observational study of Melanoma and Cutaneous Squamous Cell Carcinoma, run by Melanoma Institute Australia at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
- What is being tested?
- Predictive model
- How many people
- 1,000 participants
- Where
- 3 sitesAustralia
- Study dates
- 8 Jun 2021to 1 Jun 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with melanoma, non-melanoma skin cancer, non-melanoma solid tumours eligible for treatment with immunotherapy(ies)
Who may be able to join
- 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.
Show all 24Show fewer
- 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.
- 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.
- 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
Who cannot join
- 1. 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:
- 1. 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050
Michael Boyer, MBBS, michael.boyer@lh.org.au
Jenny Lee, MBBS
- Recruiting
Melanoma Institute Australia
Sydney, New South Wales, 2065
Georgina Long, MBBS, georgina.long@sydney.edu.au
Ines Silva, MBBS
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Matteo Carlion, MBBS, matteo.carlino@sydney.edu.au
About this study
Official title: Personalised Immunotherapy Platform (PIP) - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma
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.
Read the detailed description
The Personalised Immunotherapy Program (PIP) is a multicenter biomarker discovery and validation program of multi-omic biomarker based predictive models which aim to identify patients with immunotherapy resistant disease. PIP developed predictive models in retrospective setting, with validation within a prospective clinical observational study.
Immune checkpoint inhibitors targeting the cytotoxic T-cell lymphocyte antigen 4 (CTLA-4) and programmed cell death 1 (PD-1) receptors have revolutionised the treatment of advanced melanoma, resulting in long-term durable responses and a 5-year overall survival of 52% with combination immunotherapy. However, clinical benefit is not universal, and half of these patients do not respond. Therefore, there is an urgent need for clinically validated biomarkers which can identify patients who are at high risk of not responding to standard-of-care immunotherapies and determine which emerging clinical trial agent is most appropriate for a particular patient's disease.
Researchers performed mutation, gene expression and tumour immune profiling on tumour biopsies from melanoma patients treated with anti-PD-1 monotherapy or combined anti-PD-1 and anti-CTLA-4 therapy. From this dataset PIP has developed predictive models to identify patients with immunotherapy resistant disease.
The subsequent PIP-PREDICT is a prospective clinical study that enrols advanced cancer patients who are eligible to receive approved immunotherapies. PIP testing and biomarker reporting is used to screen potential patients. Each patient enrolled in the study receives an individual PIP Biomarker Report, which is presented as part of the established Biomarker Multidisciplinary Team (MDT) meeting of clinical oncologists, pathologists, molecular biologists, trials nursing, PIP, and biospecimen staff on a fortnightly basis.
PIP-PREDICT has a primary goal of determining the accuracy of biomarker predictions from PIP prospectively within oncology clinics. Secondary goals include assessing the feasibility of biomarker assay workflows within diagnostic providers, conducting a cost-benefit ratio analysis, evaluating the effect of biomarker reports on treatment selection within multidisciplinary teams (MDTs), and performing a post-implementation analysis of personalised immunotherapy biomarker reports in treatment decision making.
- Conditions
- Melanoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Merkel Cell Carcinoma, Solid Tumor
- Being tested
- Predictive model
- Keywords
- Biomarker, Predictive, Immunotherapy, Multi-omic, Tumour mutation burden, Gene expression, Tissue imaging, Machine learning, Multiplex immunofluorescence, Immune checkpoint inhibitors, Quantitative pathology
- Medical subject headings
- Melanoma, Carcinoma, Basal Cell, Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Melanoma cohort | Patients with melanoma who are yet to receive immunotherapy will undergo predictive biomarker testing and biomarker reporting. Receives: 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. Receives: 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. Receives: Other: Predictive model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (24)
Assessment of the inaccuracy of predictive test results
Identification of patient populations for which the predictive model did not predict response (6 month PFS) to immunotherapy
Measured: 6 months
Evaluation of a test request form - completion rate
Proportion of required data completed by the referring clinician
Measured: 2 years
Analysis of potential barriers to complete a test request form
Identification of barriers to completion of the request form
Measured: 2 years
Evaluation of accessible data in medical records for completion of a test request form
Proportion of required data that is readily available in routine patient medical records
Measured: 2 years
Evaluation of a test request form from clinician feedback via qualitative surveys
Summarised feedback from clinicians in narrative format
Measured: 2 years
Conduct qualitative surveys to evaluate a test result report from consumers' viewpoint
Survey results from consumer responses on the comprehension of risk probability (mean score from a 7 point scale), communication efficacy (mean score from a 4 point scale), significance and actionability (mean score from a 7 point scale) of the information within the report
Measured: 1 year
Qualiaitive evaluation of a test result report from consumers' viewpoint
Interviewer notes and transcriptions of consumers' answers to structured interview questions coded in software for qualitative data to identify and evaluate the most significant problems, highlight cases of poor comprehension, and assess the degree to which the reports met consumers' information needs
Measured: 1 year
Conduct qualitative surveys to evaluation of a test result report from the clinicians' viewpoint
Survey results from clinicians on the utility (mean score from a 7 point scale) and comprehension (mean score from a 7 point scale) of the report
Measured: 2 years
Qualiaitive evaluation of a test result report from clinicians' viewpoint
Summarised feedback from clinicians to structured interview questions
Measured: 2 years
Evaluation of the predictive model workflow on result completion
Identification of workflow barriers from request form to result delivery
Measured: 2 years
Evaluation of the predictive model workflow on result delivery
Time from request form submission to predictive test result delivery (business days)
Measured: 2 years
Evaluation of the predictive model workflow turnaround timeframes
Proportion of test results received within 2 weeks (10 business days) from request
Measured: 2 years
Evaluation of the predictive model workflow delays
Summary of reasons for delay in providing test result
Measured: 2 years
Evaluation of the predictive model workflow processes
Identification of processes that require change (if required), the number of identified issues found and the result of implemented changes.
Measured: 2 years
Availability of suitable tissue for the predictive model testing protocol
Proportion of patients who could not be tested because no suitable tissue available (and reasons why).
Measured: 2 years
Data quality for the predictive model testing protocol
Proportion of patients who could not be tested because of missing clinical data (and which data and why missing)
Measured: 2 years
A cost analysis of the predictive model testing protocol
Calculation of the cost per individual test (to include staff time, reagents, proportionate use of analytical equipment, assay costs, pathology service fee for sample preparation and shipping)
Measured: 2 years
Evaluation of the predictive test report in shaping clinician treatment decision making
Index of the quality of team decision making using the multidisciplinary team (MDT) metric of decision making (MODe) framework
Measured: 1 year
Evaluation of the impact of predictive test result in shaping clinician treatment decision making
Decision making with and without the knowledge of the predictive test report (Decision Impact Analysis) by the MDT
Measured: 2 years
Concordance of clinician treatment decision making with predictive test results
Concordance of treatment recommendation(s) before and after provision of the predictive test report per patient case
Measured: 2 years
Discordance of clinician treatment decision making with predictive test results
For treatment choice discordance, proportion of theoretical decisions based on the report that would be adhered to
Measured: 2 years
Exploratory evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples
Identification of biomarkers in blood and/or stools predictive of response or resistance to immunotherapy that can be incorporated into the predictive model
Measured: 5 years
Evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples on the accuracy of the predictive model
Impact of the inclusion of blood and/or stool biomarkers to the accuracy of the predictive model on predicting response to immunotherapy at 6 months post-treatment
Measured: 5 years
Assessment of the accuracy of predictive test results in non-melanoma skin cancer and non-melanoma tumours
Proportion of correctly predicted responders and non-responders to immunotherapy treatment based on the 6 month progression-free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start8 Jun 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanoma Institute Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Wilmott, PhD, Principal investigator, Melanoma Institute Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536257
- Sponsor's protocol ID
- MIA2020/283
- Acronym
- PIP-PREDICT
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37808404Mao 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.
PubMed 37055772Adegoke 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.
PubMed 37865395
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Immunotherapy Platform (PIP) - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma
- ClinicalTrials.gov ID
- NCT06536257
- Acronym / sponsor ID
- PIP-PREDICT / MIA2020/283
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Melanoma Institute AustraliaUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2037 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Personalised Immunotherapy Program (PIP) is a multicenter biomarker discovery and validation program of multi-omic biomarker based predictive models which aim to identify patients with immunotherapy resistant disease. PIP developed predictive models in retrospective setting, with validation within a prospective clinical observational study.
Immune checkpoint inhibitors targeting the cytotoxic T-cell lymphocyte antigen 4 (CTLA-4) and programmed cell death 1 (PD-1) receptors have revolutionised the treatment of advanced melanoma, resulting in long-term durable responses and a 5-year overall survival of 52% with combination immunotherapy. However, clinical benefit is not universal, and half of these patients do not respond. Therefore, there is an urgent need for clinically validated biomarkers which can identify patients who are at high risk of not responding to standard-of-care immunotherapies and determine which emerging clinical trial agent is most appropriate for a particular patient's disease.
Researchers performed mutation, gene expression and tumour immune profiling on tumour biopsies from melanoma patients treated with anti-PD-1 monotherapy or combined anti-PD-1 and anti-CTLA-4 therapy. From this dataset PIP has developed predictive models to identify patients with immunotherapy resistant disease.
The subsequent PIP-PREDICT is a prospective clinical study that enrols advanced cancer patients who are eligible to receive approved immunotherapies. PIP testing and biomarker reporting is used to screen potential patients. Each patient enrolled in the study receives an individual PIP Biomarker Report, which is presented as part of the established Biomarker Multidisciplinary Team (MDT) meeting of clinical oncologists, pathologists, molecular biologists, trials nursing, PIP, and biospecimen staff on a fortnightly basis.
PIP-PREDICT has a primary goal of determining the accuracy of biomarker predictions from PIP prospectively within oncology clinics. Secondary goals include assessing the feasibility of biomarker assay workflows within diagnostic providers, conducting a cost-benefit ratio analysis, evaluating the effect of biomarker reports on treatment selection within multidisciplinary teams (MDTs), and performing a post-implementation analysis of personalised immunotherapy biomarker reports in treatment decision making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melanoma cohort | – | Other: Predictive modelPatients with melanoma who are yet to receive immunotherapy will undergo predictive biomarker testing and biomarker reporting. |
| Non-melanoma skin cancer cohort | – | Other: Predictive modelPatients 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. |
| Solid tumour cohort | – | Other: Predictive modelPatients with non-melanoma, non-skin cancer, solid tumours who are yet to receive immunotherapy will have tumour tested using the predictive model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with melanoma, non-melanoma skin cancer, non-melanoma solid tumours eligible for treatment with immunotherapy(ies)
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (3 listed)
- 1. 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
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictive modelPatient 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. | Other | Melanoma cohort, Non-melanoma skin cancer cohort, Solid tumour cohort |
Primary outcome
Assessment of the accuracy of predictive test results in melanoma
Time frame: 6 months
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)
24 secondary outcomes
Assessment of the inaccuracy of predictive test results
Time frame: 6 months
Evaluation of a test request form - completion rate
Time frame: 2 years
Analysis of potential barriers to complete a test request form
Time frame: 2 years
Evaluation of accessible data in medical records for completion of a test request form
Time frame: 2 years
Evaluation of a test request form from clinician feedback via qualitative surveys
Time frame: 2 years
Conduct qualitative surveys to evaluate a test result report from consumers' viewpoint
Time frame: 1 year
Qualiaitive evaluation of a test result report from consumers' viewpoint
Time frame: 1 year
Conduct qualitative surveys to evaluation of a test result report from the clinicians' viewpoint
Time frame: 2 years
Qualiaitive evaluation of a test result report from clinicians' viewpoint
Time frame: 2 years
Evaluation of the predictive model workflow on result completion
Time frame: 2 years
Evaluation of the predictive model workflow on result delivery
Time frame: 2 years
Evaluation of the predictive model workflow turnaround timeframes
Time frame: 2 years
Evaluation of the predictive model workflow delays
Time frame: 2 years
Evaluation of the predictive model workflow processes
Time frame: 2 years
Availability of suitable tissue for the predictive model testing protocol
Time frame: 2 years
Data quality for the predictive model testing protocol
Time frame: 2 years
A cost analysis of the predictive model testing protocol
Time frame: 2 years
Evaluation of the predictive test report in shaping clinician treatment decision making
Time frame: 1 year
Evaluation of the impact of predictive test result in shaping clinician treatment decision making
Time frame: 2 years
Concordance of clinician treatment decision making with predictive test results
Time frame: 2 years
Discordance of clinician treatment decision making with predictive test results
Time frame: 2 years
Exploratory evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples
Time frame: 5 years
Evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples on the accuracy of the predictive model
Time frame: 5 years
Assessment of the accuracy of predictive test results in non-melanoma skin cancer and non-melanoma tumours
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 37808404Gide 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.
- Results publication: PubMed 37055772Mao 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.
- Results publication: PubMed 37865395Adegoke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Wilmott, PhD principal investigator
Melanoma Institute Australia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Cutaneous Squamous Cell Carcinoma, run by Melanoma Institute Australia at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Personalised Immunotherapy Program Manager (+61 2 9911 7200, PIP@melanoma.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the accuracy of predictive test results in melanoma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536257, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.