Predictive biomarker study of immune checkpoint inhibitors in metastatic head and neck squamous cell carcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0007598
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS and OS based on dynamic changes in allele frequency of ctDNA mutations between pre- and post-treatment sample
- Secondary Outcome Measures
Name Time Method dynamic change of allele frequency between responders and non-responders