Squamous Cell Carcinoma of the Oral CavityHEATNCT06380686
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
An observational study of Squamous Cell Carcinoma of the Oral Cavity and Squamous Cell Carcinoma of the Oropharynx, run by AIO-Studien-gGmbH at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Hypopharynx
- What is being tested?
- data collection
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Nov 2024to Feb 2030
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Universitätsklinikum Essen
Essen, 45147
Michael Pogorzelski, Dr. med., +49 (0) 157 38 79 55 41, Michael.Pogorzelski@uk-essen.de
- Recruiting
Onkologie/Studienzentrum am Raschplatz GbR
Hanover, 30161
Eyck von der Heyde, Dr. med., +49 (0) 511 86649985, vdheyde@onkologie-am-raschplatz.de
About this study
Official title: 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.
Read the 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.
- 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
- Being tested
- data collection
- Keywords
- SCCHN
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Demography, Social history, Riskfactors, Relevant medical history, Oncological family history, Disease \& treatment history, Molecular Pathology and Results, Treatment data, Response data, progession free survial, overall survival.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic factors
Highest level of education, Employment status, Current professional activity, Professional risk factors, Level of self-sufficiency, Care degree
Measured: 3 years
Treatments
Types of local therapies (surgery, radiotherapy, radiochemotherapy), systemic therapy and therapeutic sequences
Measured: 3 years
Response rates
Response rates
Measured: 3 years
Treatment decision
Physician-reported parameters affecting treatment decision
Measured: 3 years
Progression-free survival
Progression-free survival
Measured: 3 years
Time-to-treatment-failure
Time-to-treatment-failure
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start7 Nov 2024
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Oral CavityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Victor Grünwald, Prof. Dr., Study director, Universitätsklinikum EssenMichael Pogorzelski, Dr., Principal investigator, Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380686
- Sponsor's protocol ID
- AIO-KHT-0322/ass
- Acronym
- HEAT
- Status last verified
- Nov 2026
- First submitted
- 12 Apr 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based
- ClinicalTrials.gov ID
- NCT06380686
- Acronym / sponsor ID
- HEAT / AIO-KHT-0322/ass
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionDemography, Social history, Riskfactors, Relevant medical history, Oncological family history, Disease \& treatment history, Molecular Pathology and Results, Treatment data, Response data, progession free survial, overall survival. | Other | – |
Primary outcome
Sociodemographic factors
Time frame: 3 years
Highest level of education, Employment status, Current professional activity, Professional risk factors, Level of self-sufficiency, Care degree
Treatments
Time frame: 3 years
Types of local therapies (surgery, radiotherapy, radiochemotherapy), systemic therapy and therapeutic sequences
Response rates
Time frame: 3 years
Response rates
Treatment decision
Time frame: 3 years
Physician-reported parameters affecting treatment decision
Progression-free survival
Time frame: 3 years
Progression-free survival
Time-to-treatment-failure
Time frame: 3 years
Time-to-treatment-failure
Overall survival
Time frame: 3 years
Overall survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Grünwald, Prof. Dr. study director
Universitätsklinikum Essen
Michael Pogorzelski, Dr. principal investigator
Universitätsklinikum Essen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Oral Cavity and Squamous Cell Carcinoma of the Oropharynx, run by AIO-Studien-gGmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+49 (0)30 814534431, kht-register@aio-studien-ggmbh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic factors (time frame: 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.