Trial Title:
Personalised Immunotherapy Platform
NCT ID:
NCT06536257
Condition:
Melanoma
Cutaneous Squamous Cell Carcinoma
Basal Cell Carcinoma
Merkel Cell Carcinoma
Solid Tumor
Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Melanoma
Carcinoma, Basal Cell
Conditions: Keywords:
Biomarker
Predictive
Immunotherapy
Multi-omic
Tumour mutation burden
Gene expression
Tissue imaging
Machine learning
Multiplex immunofluorescence
Immune checkpoint inhibitors
Quantitative pathology
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Predictive model
Description:
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.
Arm group label:
Melanoma cohort
Arm group label:
Non-melanoma skin cancer cohort
Arm group label:
Solid tumour cohort
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.
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.
Criteria for eligibility:
Study pop:
Patients with melanoma, non-melanoma skin cancer, non-melanoma solid tumours eligible for
treatment with immunotherapy(ies)
Sampling method:
Non-Probability Sample
Criteria:
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 therapy has been
completed and the biopsy represents this relapsed disease
6. RECIST version 1.1 measurable disease.
7. Tissue sample must be representative of the whole tumour and therefore excision
biopsies are preferred over core biopsies.
8. A life expectancy over 6 months.
9. Prior treatment with BRAF (B-Raf proto-oncogene) / MEK (mitogen-activated protein
kinase) inhibitors are acceptable, providing the other eligibility criteria are met.
10. 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.
Exclusion Criteria:
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:
Inclusion Criteria:
1. Written informed consent to participation for the use of tumour tissue and
collection of standard clinical data
2. Histologically confirmed cancer and eligibility to receive immunotherapy treatment.
3. Availability of a tissue sample where no systemic treatments were administered
between sample procurement and proposed PIP testing
4. 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.
5. 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.
6. 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.
7. The tissue sample must be representative of the whole tumour and therefore excision
biopsies are preferred over core biopsies.
8. A life expectancy over 6 months.
9. Prior treatment with targeted therapies are acceptable, providing the other
eligibility criteria are met.
10. 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
Exclusion Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Sydney
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Michael Boyer, MBBS
Email:
michael.boyer@lh.org.au
Investigator:
Last name:
Jenny Lee, MBBS
Email:
Sub-Investigator
Facility:
Name:
Melanoma Institute Australia
Address:
City:
Sydney
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Georgina Long, MBBS
Email:
georgina.long@sydney.edu.au
Investigator:
Last name:
Ines Silva, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Richard Scolyer, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Alexander Menzies, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Serigne Lo, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Anne Cust, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Rachael Morton, PhD
Email:
Sub-Investigator
Facility:
Name:
Westmead Hospital
Address:
City:
Sydney
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Matteo Carlion, MBBS
Email:
matteo.carlino@sydney.edu.au
Start date:
June 8, 2021
Completion date:
June 1, 2037
Lead sponsor:
Agency:
Melanoma Institute Australia
Agency class:
Other
Source:
Melanoma Institute Australia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06536257
