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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04606940
Recruitment Status : Completed
First Posted : October 28, 2020
Last Update Posted : May 19, 2022
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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
Head and Neck Cancer Advanced Cancer Metastatic Cancer HNSCC Squamous Cell Carcinoma

Study Design
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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 : October 19, 2020
Actual Primary Completion Date : October 12, 2021
Actual Study Completion Date : October 12, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  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). [ Time Frame: 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 :
  1. The changes in ctDNA levels will be measured. These value will help correlate with progression free survival (PFS) and overall survival (OS). [ Time Frame: 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.

  2. The optimal time-point will be measured to analyze ctDNA as a predictive marker of response to immune checkpoint inhibitors (anti-PD-1 antibody). [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood samples collected serially for cfDNA and gDNA extraction. Archived tumor sample collected for tumor genomic DNA analysis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606940


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Lillian Siu Princess Margaret Cancer Centre
Principal Investigator: Scott Bratman Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04606940    
Other Study ID Numbers: IO-KIN
20-5803 ( Other Identifier: CAPCR ID )
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Targeted gene sequencing results, along with limited clinical information that does not identify the patient as an individual, such as age, partial date of birth (year, month), gender, cancer type, and pathology information related to the samples tested, and survival time may be shared with collaborating researchers.

Data from this study can be shared through two types of databases: open-access or controlled-access. An open-access database is publicly accessible and contains limited clinical information and analyses of samples. A controlled-access database contains more detailed clinical information, such as relevant past medical history and the results of prior and ongoing cancer treatments, and analyses of samples, but is only accessible to researchers who sign agreements defining how data may be used. All data will be stripped of all personal identifying information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Head and Neck
Immune Checkpoint Inhibitors
Immuno-oncology
 Liquid Biopsy
Advanced Cancer
Metestatic Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell