Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-12
Brief Title:
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers Treatment and Outcome
Sponsor:
AIO-Studien-gGmbH
Organization:
AIO-Studien-gGmbH
Study Overview
Official Title:
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAT
Brief Summary:
Prospective open non-interventional multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrentmetastatic head and neck tumor patients
Detailed Description:
The advent of checkpoint inhibitors has changed the treatment landscape in SCCHN and new treatment sequences have entered clinical practice
More in-depth knowledge of tumor biomarkers are important measures for optimization of treatment strategies in SCCHN In addition to this investigations may involve other assessments which will be explored separately such as molecular testing These tests are then linked to the core data set and will allow to associate such measures with outcomes This concept is flexible and allows for rapid integration of contemporary research questions in a timely manner
Furthermore insights into the treatment reality for recurrentmetastatic salivary gland carcinoma and other rare tumor entities SNUC etc are urgently needed as there is currently no established standard of care
The monoclonal antibody cetuximab in combination with platinum and fluorouracil EXTREME has been the standard of care for recurrent or metastatic rm SCCHN for over a decade1 Recently the immune checkpoint inhibitors CPIs nivolumab and pembrolizumab have changed the therapeutic landscape of patients with rm SCCHN Nivolumab is considered as therapeutic standard after failure of platinum-based therapy based on the results of the phase III Checkmate-141 trial2 In addition pembrolizumab has become the new standard in the first-line setting in combination with platinumfluorouracil chemotherapy or as monotherapy for patients with programmed cell death ligand 1 PD-L1 positive tumors based on the data from the phase III Keynote-048 trial3 Moreover cetuximab in combination with platinum and docetaxel TPEx has emerged as a less toxic alternative to the EXTREME regimen4 Due to the shifting first-line treatment landscape data to guide contemporary 2nd line therapy are scarce and the optimal treatment sequence remains vague256 The implementation of biomarkers and selection of patients in a real-world setting are areas of academic interest In addition the assessment of treatment outcomes in rare entities are underrepresented in pivotal trials and as a matter of fact may be completely excluded However broad labels permit the use of novel agents but a larger body of evidence is needed to substantiate such treatment choices HEAT seeks to address these questions by inclusion of a real-world patient population and continuous assessment of oncological outcomes by means of a core clinical data set implemented into HEAT
Overall HEAT is a study platform which continuously assesses clinical outcomes and modularly integrates additional measures to enable rapid answers to research questions
More in-depth knowledge of tumor biomarkers are important measures for optimization of treatment strategies in SCCHN In addition to this investigations may involve other assessments which will be explored separately such as molecular testing These tests are then linked to the core data set and will allow to associate such measures with outcomes This concept is flexible and allows for rapid integration of contemporary research questions in a timely manner
Furthermore insights into the treatment reality for recurrentmetastatic salivary gland carcinoma and other rare tumor entities SNUC etc are urgently needed as there is currently no established standard of care
The monoclonal antibody cetuximab in combination with platinum and fluorouracil EXTREME has been the standard of care for recurrent or metastatic rm SCCHN for over a decade1 Recently the immune checkpoint inhibitors CPIs nivolumab and pembrolizumab have changed the therapeutic landscape of patients with rm SCCHN Nivolumab is considered as therapeutic standard after failure of platinum-based therapy based on the results of the phase III Checkmate-141 trial2 In addition pembrolizumab has become the new standard in the first-line setting in combination with platinumfluorouracil chemotherapy or as monotherapy for patients with programmed cell death ligand 1 PD-L1 positive tumors based on the data from the phase III Keynote-048 trial3 Moreover cetuximab in combination with platinum and docetaxel TPEx has emerged as a less toxic alternative to the EXTREME regimen4 Due to the shifting first-line treatment landscape data to guide contemporary 2nd line therapy are scarce and the optimal treatment sequence remains vague256 The implementation of biomarkers and selection of patients in a real-world setting are areas of academic interest In addition the assessment of treatment outcomes in rare entities are underrepresented in pivotal trials and as a matter of fact may be completely excluded However broad labels permit the use of novel agents but a larger body of evidence is needed to substantiate such treatment choices HEAT seeks to address these questions by inclusion of a real-world patient population and continuous assessment of oncological outcomes by means of a core clinical data set implemented into HEAT
Overall HEAT is a study platform which continuously assesses clinical outcomes and modularly integrates additional measures to enable rapid answers to research questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None