Actively Recruiting
Personalised Immunotherapy Platform
Led by Melanoma Institute Australia · Updated on 2025-09-18
1000
Participants Needed
3
Research Sites
833 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Personalised Immunotherapy Platform
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent for use of tumor tissue, blood, stool, and clinical data collection
- Histologically confirmed resected stage II (high risk), III, or IV melanoma or unresectable stage III or IV melanoma
- Eligible to receive immunotherapy treatment
- Availability of a tumor tissue sample obtained at surgery with no systemic treatments between sample procurement and testing
- Patients with previous adjuvant or neoadjuvant therapy are eligible if disease has recurred and biopsy represents relapsed disease
- Measurable disease by RECIST version 1.1
- Tissue sample representative of whole tumor; excision biopsies preferred
- Life expectancy over 6 months
- Prior treatment with BRAF/MEK inhibitors allowed if other criteria met
- Biopsy for biomarker testing must be from an area outside prior radiotherapy field if applicable
- For non-melanoma cancers, histologically confirmed diagnosis and eligibility for immunotherapy
- Availability of tissue sample with no systemic treatments between collection and testing
- New biopsy allowed if treatment occurred after last sample, used for routine or trial screening
- Clinically detectable disease by RECIST, PET avidity, clinical evidence (photographic, CT, palpable), or diagnosable signs or symptoms
- Life expectancy over 6 months
- Prior targeted therapies allowed if other criteria met
- Biopsy for biomarker testing must be from area outside prior radiotherapy field if applicable
You will not qualify if you...
- Positive test for hepatitis B virus surface antigen or hepatitis C virus RNA indicating acute or chronic infection, unless treated for at least one year
- Known history of testing positive for HIV or AIDS
- No new testing required solely for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia, 2050
Actively Recruiting
2
Melanoma Institute Australia
Sydney, New South Wales, Australia, 2065
Actively Recruiting
3
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
Research Team
P
Personalised Immunotherapy Program Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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