Multi-omics profiling to optimize immunotherapy for advanced head and neck cancer
Official title: Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy(HARMONI)
Run by Samsung Medical Center · NCT07211139 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, pembrolizumab, nivolumab, cetuximab, immunotherapy |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | July 8, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07211139 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Samsung Medical Center
Seoul, Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Jinyoung Kim, M.D.
- Email: lisakjy@gmail.com
- Phone: +821066576474
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)
This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.
-
Airway ultrasound in head and neck cancer patients
This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.
-
Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia
This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.
-
Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer
In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.
-
SumMET: Targeted radioligand therapy for c-MET–positive solid tumors
This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.
-
Using Silverlon for head and neck patients with tracheostomies
This early-phase study tests whether Silverlon dressings can prevent severe skin reactions under tracheostomy collars in adults with head and neck cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.