Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome (HEAT)

Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based

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.

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of the Larynx; Squamous Cell Carcinoma of the Oral Cavity; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Hypopharynx
• Intervention / Treatment: Other: data collection

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: +49 (0)30 814534431; Email: kht-register@aio-studien-ggmbh.de

Study Locations

• Germany
  • Essen, Germany, 45147
    • Not yet recruiting
    • Universitätsklinikum Essen
    • Contact: Michael Pogorzelski, Dr. med.; Phone Number: +49 (0) 157 38 79 55 41; Email: Michael.Pogorzelski@uk-essen.de
  • Hannover, Germany, 30161
    • Recruiting
    • Onkologie/Studienzentrum am Raschplatz GbR
    • Contact: Eyck von der Heyde, Dr. med.; Phone Number: +49 (0) 511 86649985; Email: vdheyde@onkologie-am-raschplatz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	3 years
Progression-free survival	Progression-free survival	3 years
Sociodemographic factors	Highest level of education, Employment status, Current professional activity, Professional risk factors, Level of self-sufficiency, Care degree	3 years
Treatments	Types of local therapies (surgery, radiotherapy, radiochemotherapy), systemic therapy and therapeutic sequences	3 years
Response rates	Response rates	3 years
Treatment decision	Physician-reported parameters affecting treatment decision	3 years
Time-to-treatment-failure	Time-to-treatment-failure	3 years

Collaborators and Investigators

• Sponsor: AIO-Studien-gGmbH
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Victor Grünwald, Prof. Dr., Universitätsklinikum Essen; Principal Investigator: Michael Pogorzelski, Dr., Universitätsklinikum Essen

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: SCCHN
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: AIO-KHT-0322/ass

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No