Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 3 years after enrollment.
- description
- Time from initiation of treatment to death from any cause. Estimated using Kaplan-Meier survival analysis. The effect of clinical and treatment variables on survival will be evaluated using the Cox proportional hazards model.
- measure
- Treatment Response
- timeFrame
- From treatment initiation until disease progression or death, whichever occurs first, assessed every 6-12 weeks, up to 36 months.
- description
- Tumor response evaluated according to RECIST v1.1 criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease).
Secondary outcomes (3)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Time Frame: Up to 3 years after enrollment.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDBraakhuis BJ, Graveland AP, Dijk F, Ylstra B, van Wieringen WN, Leemans CR, Brakenhoff RH. Expression signature in peripheral blood cells for molecular diagnosis of head and neck squamous cell carcinoma. Oral Dis. 2013 Jul;19(5):452-5. doi: 10.1111/odi.12019. Epub 2012 Oct 3. PMID 23034102
- BACKGROUNDBurtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1. PMID 31679945
- BACKGROUNDFang R, Chen Y, Huang B, Wang Z, Zhu X, Liu D, Sun W, Chen L, Zhang M, Lyu K, Lei W. Predicting response to PD-1 inhibitors in head and neck squamous cell carcinomas using peripheral blood inflammatory markers. Transl Oncol. 2025 Jan;51:102222. doi: 10.1016/j.tranon.2024.102222. Epub 2024 Dec 1. PMID 39616985
- BACKGROUNDHarrington KJ, Burtness B, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023 Feb 1;41(4):790-802. doi: 10.1200/JCO.21.02508. Epub 2022 Oct 11. PMID 36219809
- BACKGROUNDIdel C, Fleckner J, Plotze-Martin K, Werner L, Rades D, Theodoraki MN, Hofmann L, Huber D, Leichtle A, Hoffmann TK, Bruchhage KL, Pries R. Partial recovery of peripheral blood monocyte subsets in head and neck squamous cell carcinoma patients upon radio(chemo)therapy is associated with decreased plasma CXCL11. BMC Cancer. 2024 Apr 12;24(1):459. doi: 10.1186/s12885-024-12177-x.