Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)

  • days left to enroll
  • participants needed
  • sponsor
    University Health Network, Toronto
Updated on 7 May 2021
head and neck cancer
neck cancer
metastatic head and neck cancer


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.

Condition Metastasis, Bone Metastases, Metastatic Cancer, Brain Metastases, Liver Metastases, Neoplasm Metastasis, Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Squamous cell carcinoma, Squamous cell carcinoma, head and neck cancer, head and neck cancer, Vulvar Dysplasia and Carcinoma, Liver Metastases, Bone Metastases, Advanced Cancer, Squamous Cell Carcinoma of the Head and Neck, Brain Metastases, Squamous Cell Carcinoma of Head and Neck, Advanced Malignancies, HNSCC, Cancer, Metastatic, Metastatic Cancer, Neoplasm Metastasis, cancer advanced, cancer of the head and neck, cancers metastatic, epidermoid carcinoma, squamous cell cancer, metastases, metastatic disease, secondary cancer, secondaries, metastatic tumor, metastasized
Clinical Study IdentifierNCT04606940
SponsorUniversity Health Network, Toronto
Last Modified on7 May 2021


Yes No Not Sure

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)
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