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

NCT04606940 | Completed

• 2 other identifiers: IO-KIN20-5803
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  Through study completion, up to 1.5 years

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of advanced/metastatic head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx or unknown origin (but being treated as HNSCC) and are receiving at least one dose of nivolumab or pembrolizumab.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected serially for cfDNA and gDNA extraction. Archived tumor sample collected for tumor genomic DNA analysis.

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasm Metastasis; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Lillian Siu

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

• Scott Bratman

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 28, 2020
• Study Start: October 19, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

CA (1)