Clinical trial NCT06380686: Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Official title: Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of the Oral Cavity
Squamous Cell Carcinoma of the Oropharynx
Squamous Cell Carcinoma of the Hypopharynx
Squamous Cell Carcinoma of the Larynx
Keywords: SCCHN
Lead sponsor: AIO-Studien-gGmbH
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with histologically or cytologically confirmed malignancy of the head neck area including but not limited to

* squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx
* not amenable for curative treatment who receive palliative systemic treatment or best supportive care.

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 recurrent/metastatic 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 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Able to understand and willing to sign written informed consent
* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx)
* Patients not amenable for curative treatment who receive palliative systemic treatment or best supportive care
* Informed consent no later than four weeks after start of first-line palliative systemic treatment. For patients receiving "best supportive care only": no later than six weeks after diagnosis/recurrence or metastatic disease

Exclusion Criteria: none

Primary outcomes:
measure: Sociodemographic factors
timeFrame: 3 years
measure: Treatments
timeFrame: 3 years
measure: Response rates
timeFrame: 3 years
measure: Treatment decision
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Time-to-treatment-failure
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hannover
country: Germany
facility: Onkologie/Studienzentrum am Raschplatz GbR
Study officials:
affiliation: Universitätsklinikum Essen
name: Victor Grünwald, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Essen
name: Michael Pogorzelski, Dr.
role: PRINCIPAL_INVESTIGATOR
References: