Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536257
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-30
Brief Title:
Personalised Immunotherapy Platform
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalised Immunotherapy Platform PIP - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIP-PREDICT
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None