Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06380686 |
| Other study ID # |
AIO-KHT-0322/ass |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
May 2030 |
Study information
| Verified date |
April 2024 |
| Source |
AIO-Studien-gGmbH |
| Contact |
Project Manager |
| Phone |
+49 (0)30 814534431 |
| Email |
acticca-2[@]aio-studien-ggmbh.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
recurrent/metastatic head and neck tumor patients.
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 recurrent/metastatic 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 (r/m) SCCHN for over a decade.1
Recently, the immune checkpoint inhibitors (CPIs) nivolumab and pembrolizumab have changed
the therapeutic landscape of patients with r/m SCCHN. Nivolumab is considered as therapeutic
standard after failure of platinum-based therapy based on the results of the phase III
Checkmate-141 trial.2 In addition, pembrolizumab has become the new standard in the
first-line setting in combination with platinum/fluorouracil 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 trial.3 Moreover, cetuximab in combination with platinum and
docetaxel (TPEx) has emerged as a less toxic alternative to the EXTREME regimen.4 Due to the
shifting first-line treatment landscape, data to guide contemporary 2nd line therapy are
scarce and the optimal treatment sequence remains vague.2,5,6 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.
