Official Title
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.
Brief Title
Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)
Protocol ID
NCT04606940
Lead Sponsor
University Health Network, Toronto
Brief Summary
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.
Study Period
-
Enrollment Count
18 participants
Eligibility Criteria
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).
Filters
Head and Neck Cancer
Advanced Cancer
Metastatic Cancer
HNSCC
Squamous Cell Carcinoma
COMPLETED
ADULT
OLDER_ADULT