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

Conditions

Advanced Cancer, Head and Neck Cancer, HNSCC, Metastatic Cancer, Squamous Cell Carcinoma

Keywords

Head and Neck, Immune Checkpoint Inhibitors, Immuno-oncology, Liquid Biopsy, Advanced Cancer, Metestatic Cancer

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.

Grégoire Marret, Jinsu An, Farnoosh Abbas‐Aghababazadeh, Kewei Ni, Lucas Penny et al. (17 authors)

Cancer Research2026-04-17

10.1158/1538-7445.am2026-lb122

Data from Investigating Early Kinetics in Plasma ctDNA and Peripheral T-cell Receptor Repertoire to Predict Treatment Outcomes to PD-1 Inhibitors in Head and Neck Squamous Cell Carcinoma

Enrique Sanz-Garcia, Shirin Soleimani, Jeff Bruce, Stephanie Pedersen, Marian Tang et al. (20 authors)

2026-02-17

10.1158/1078-0432.c.8313719

Investigating Early Kinetics in Plasma ctDNA and Peripheral T Cell Receptor Repertoire to Predict Treatment Outcomes to PD-1 Inhibitors in Head and Neck Cancer.

Sanz-Garcia E, Soleimani S, Bruce JP, Pedersen S, Tang M, Avery L, Eagles J, Spreafico A, Hansen AR, Eng L, Laliotis G, Krainock M, Liu M, Basra P, Yu C, Felicen S, Ohashi PS, Bratman SV, Pugh TJ, Siu LL.

2025-12-19

10.1158/1078-0432.ccr-25-3541

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results