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Predictive biomarker study of immune checkpoint inhibitors in metastatic head and neck squamous cell carcinoma

Biomarker Study of Immune Checkpoint Inhibitors in Metastatic Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007598
Enrollment
50
Registered
2022-08-03
Start date
2022-09-27
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
PFS and OS based on dynamic changes in allele frequency of ctDNA mutations between pre- and post-treatment sample

Secondary

MeasureTime frame
dynamic change of allele frequency between responders and non-responders

Countries

Korea, Republic of

Contacts

Public ContactWonyoung Choi

National Cancer Center

wonyoungchoi@ncc.re.kr+82-31-920-0896

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026