None listed
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Metastatic HNSCC patients who are expected to undergo monotherapy of nivolumab or pembrolizumab 2. Expected survival is at least 12 weeks 3. Patient must provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with poor performance status (ECOG 3 or 4), and with an expected survival of 12 weeks or shorter. 2. Patients who were previously diagnosed with another type of malignancy within 5 years of study enrollment date. 3. Previous treatment history with immune checkpoint inhibitors (including anti-CTLA4 antibodies) 4. Patients who do not consent to this study 5. Patients who are not feasible to obtain study samples 6. Patients who are not feasible for thorough communication 7. Patients who do not consent to using their samples for subsequent research purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS and OS based on dynamic changes in allele frequency of ctDNA mutations between pre- and post-treatment sample | — |
Secondary
| Measure | Time frame |
|---|---|
| dynamic change of allele frequency between responders and non-responders | — |
Countries
Korea, Republic of
Contacts
National Cancer Center