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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.