Multi-omics profiling to optimize immunotherapy for advanced head and neck cancer

Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy(HARMONI)

This project will test whether detailed tumor and blood profiling before and after first-line chemotherapy plus immunotherapy can help identify which people with recurrent or metastatic head and neck squamous cell carcinoma benefit.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (other)
• Drugs / interventions: chemotherapy, pembrolizumab, nivolumab, cetuximab, immunotherapy
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07211139 on ClinicalTrials.gov

What this trial studies

This observational study collects paired tumor tissue and blood samples from patients with recurrent or metastatic head and neck squamous cell carcinoma who received first-line combination therapy with an immune checkpoint inhibitor and cytotoxic chemotherapy. Researchers will perform multi-omics and spatial analyses of the tumor microenvironment and systemic immune changes before and after treatment to look for signatures tied to response. p16 and PD-L1 status will be evaluated within the institution and integrated with molecular data. The study is conducted at Samsung Medical Center and uses existing clinical care events to obtain samples and data.

Who should consider this trial

Good fit: Ideal candidates are adults (age ≥20) with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who received first-line immune checkpoint inhibitor plus cytotoxic chemotherapy and have tumor tissue available at Samsung Medical Center.

Not a fit: Patients who have not received first-line combination chemo plus immunotherapy, those without available tumor tissue at the center, or those with non-squamous head and neck cancers are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the work could identify biomarkers that predict who will respond to immunotherapy, enabling more personalized treatment and sparing nonresponders from ineffective therapies.

How similar studies have performed: Immune checkpoint inhibitors have shown survival benefits in head and neck cancer and PD-L1 correlates imperfectly with response, but spatial paired pre/post multi-omics comparisons like this are largely novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Not meeting the inclusion criteria
* Considered ineligible for enrollment at the discretion of the investigator

Where this trial is running

Seoul, Seoul

• Samsung Medical Center — Seoul, Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Jinyoung Kim, M.D.

Conditions: Head and Neck Cancer