NCT07211139Recruiting
Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy
Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy(HARMONI)
Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Head and neck squamous cell carcinoma is a heterogeneous cancer with varying prognoses depending on anatomical location and characteristics, and advanced cancers have a poor prognosis. This study aimed to examine changes in the tumor microenvironment and systemic immune system before and after combination therapy with immune checkpoint inhibitors, the standard first-line treatment for head and neck cancer. The rationale for this research and development project is as follows: 1. While immune checkpoint inhibitors have improved survival rates for head and neck cancer patients, they are only effective in approximately 15% of patients. Because biomarkers predicting treatment response have not yet been clearly identified, targeting target patient populations is challenging. 2. While numerous studies have examined the tumor microenvironment in head and neck cancer, no studies have spatially compared dynamic changes before and after immune checkpoint inhibitor treatment using paired tissue and blood biopsies. Therefore, the specific treatment mechanisms remain unclear. 3. Little is known about how changes in the tumor microenvironment are reflected in the peripheral blood, making noninvasive treatment response monitoring difficult. 4. Immune checkpoint inhibitor treatment is known to enhance the efficacy of subsequent taxane-based chemotherapy, but the mechanism remains unknown. Therefore, we aim to explore biomarkers that predict treatment response to combination therapy with immune checkpoint inhibitors and cytotoxic chemotherapy in patients with advanced/metastatic head and neck cancer and develop personalized treatment strategies.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 8 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Samsung Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT07211139
What you commit to
- Study type: Observational
- Planned participants: 30
- From 8 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not meeting the inclusion criteria
- Considered ineligible for enrollment at the discretion of the investigator
Who the study is looking for
- Histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
- Received first-line combination therapy with immune checkpoint inhibitor and cytotoxic chemotherapy
- Availability of tumor tissue samples at Samsung Medical Center
- p16 and PD-L1 expression status evaluable within the institution
- Age ≥ 20 years
- Ability to understand the study purpose and provide written informed consent
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.