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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT04606940

Collaborator

Princess Margaret Hospital, Canada (Other)

Enrollment

Location

11.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Advanced Cancer Metastatic Cancer HNSCC Squamous Cell Carcinoma

Study Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Actual Study Start Date :

Oct 19, 2020

Actual Primary Completion Date :

Oct 12, 2021

Actual Study Completion Date :

Oct 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
IO-KIN 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).

Outcome Measures

Primary Outcome Measures

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). [Through study completion, up to 1.5 years]
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 Outcome Measures

The changes in ctDNA levels will be measured. These value will help correlate with progression free survival (PFS) and overall survival (OS). [Through study completion, up to 1.5 years]
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.
The optimal time-point will be measured to analyze ctDNA as a predictive marker of response to immune checkpoint inhibitors (anti-PD-1 antibody). [Through study completion, up to 1.5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).