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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06536257




Registration number
NCT06536257
Ethics application status
Date submitted
30/03/2024
Date registered
2/08/2024

Titles & IDs
Public title
Personalised Immunotherapy Platform
Scientific title
Personalised Immunotherapy Platform (PIP) - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma
Secondary ID [1] 0 0
MIA2020/283
Universal Trial Number (UTN)
Trial acronym
PIP-PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Cutaneous Squamous Cell Carcinoma 0 0
Basal Cell Carcinoma 0 0
Merkel Cell Carcinoma 0 0
Solid Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Predictive model

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

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.

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 interventions: Predictive model
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of the accuracy of predictive test results in melanoma
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Assessment of the inaccuracy of predictive test results
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Evaluation of a test request form - completion rate
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Analysis of potential barriers to complete a test request form
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Evaluation of accessible data in medical records for completion of a test request form
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Evaluation of a test request form from clinician feedback via qualitative surveys
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Conduct qualitative surveys to evaluate a test result report from consumers' viewpoint
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
Qualiaitive evaluation of a test result report from consumers' viewpoint
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Conduct qualitative surveys to evaluation of a test result report from the clinicians' viewpoint
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Qualiaitive evaluation of a test result report from clinicians' viewpoint
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Evaluation of the predictive model workflow on result completion
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Evaluation of the predictive model workflow on result delivery
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Evaluation of the predictive model workflow turnaround timeframes
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Evaluation of the predictive model workflow delays
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Evaluation of the predictive model workflow processes
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Availability of suitable tissue for the predictive model testing protocol
Timepoint [15] 0 0
2 years
Secondary outcome [16] 0 0
Data quality for the predictive model testing protocol
Timepoint [16] 0 0
2 years
Secondary outcome [17] 0 0
A cost analysis of the predictive model testing protocol
Timepoint [17] 0 0
2 years
Secondary outcome [18] 0 0
Evaluation of the predictive test report in shaping clinician treatment decision making
Timepoint [18] 0 0
1 year
Secondary outcome [19] 0 0
Evaluation of the impact of predictive test result in shaping clinician treatment decision making
Timepoint [19] 0 0
2 years
Secondary outcome [20] 0 0
Concordance of clinician treatment decision making with predictive test results
Timepoint [20] 0 0
2 years
Secondary outcome [21] 0 0
Discordance of clinician treatment decision making with predictive test results
Timepoint [21] 0 0
2 years
Secondary outcome [22] 0 0
Exploratory evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples
Timepoint [22] 0 0
5 years
Secondary outcome [23] 0 0
Evaluation of potential new biomarkers of immunotherapy response or resistance in blood and stool samples on the accuracy of the predictive model
Timepoint [23] 0 0
5 years
Secondary outcome [24] 0 0
Assessment of the accuracy of predictive test results in non-melanoma skin cancer and non-melanoma tumours
Timepoint [24] 0 0
6 months

Eligibility
Key inclusion criteria
MELANOMA:



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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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



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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2037
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [2] 0 0
Melanoma Institute Australia - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma Institute Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Wilmott, PhD
Address 0 0
Melanoma Institute Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Personalised Immunotherapy Program Manager
Address 0 0
Country 0 0
Phone 0 0
+61 2 9911 7200
Fax 0 0
Email 0 0
PIP@melanoma.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT06536257