Clinical trial · Observational
Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)
Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology: Intense Dynamic Monitoring of ctDNA in Advanced/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients Treated With Immune Checkpoint Inhibitors.
- 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)
This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- IO-KIN
- description
- Patients with a histological or cytological confirmed recurrent, metastatic or advanced HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as HNSCC). Patients who are going to receive at least one dose of anti-PD1 antibody (nivolumab or pembrolizumab).
Primary outcomes (1)
- measure
- The change in kinetics of ctDNA changes in advanced/metastatic will be measured for HNSCC patients treated with immune checkpoint inhibitors (anti-PD-1 antibody).
- timeFrame
- Through study completion, up to 1.5 years
- description
- At each time-point, absolute ctDNA levels will be calculated from all test targets (including undetected targets).The change in ctDNA from baseline to every time-point is defined as the percentage change in absolute ctDNA levels in plasma at that end point since baseline.
Secondary outcomes (2)
- measure
- The changes in ctDNA levels will be measured. These value will help correlate with progression free survival (PFS) and overall survival (OS).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytological confirmed recurrent, metastatic or advanced HNSCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as HNSCC). * Availability of tumor sample. * Patients who are going to receive at least one dose of anti-PD1antibody (nivolumab or pembrolizumab). Exclusion Criteria: * Nasopharynx, maxillary sinus, nasal/nasal vestibule squamous tumors * Patients who are receiving concomitantly any other tumor-specific treatment (chemotherapy, radiotherapy, any monoclonal antibodies different from anti- PD-1 antibodies).
References
Publications (0)
Data not yet available