HNSCC Clinical Trial
Official title:
Using Whole-Genome Analysis on Cancer Tissue of Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma Who Underwent Nivolumab to Precisely Predict Responders: An Observational Biomarker Study
NCT number | NCT03917537 |
Other study ID # | PRECISION-01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | March 31, 2022 |
To choose a subgroup who could clearly benefit from Nivolumab, we are proposing a prospective observational study. Whole-genome study (WGS) analysis will be performed on archived cancer tissues from patients who were (1) cisplatin-refractory and subsequently (2) received Nivolumab (at least 4 doses) and (3) had completed imaging response evaluation at 3-4 month after Nivolumab. The estimated sample size was designed to be 80, including 20 responders and 60 non-responders (1:3 design) after Nivolumab alone at a dosage of 2-3mg/kg every 2 weeks (+/- 7 days could be allowed), given the minimal requirement of statistical significance. The specific bio-signature(s) found in this prospective observational study could possibly greatly contribute to precision immuno-oncology medicine, especially Nivolumab.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Age above 20 years old Exclusion Criteria: - Age below 20 years old |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan | |
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prediction rate of Nivolumab Response | Prediction rate of Nivolumab Response | 2-4 months | |
Secondary | Adverse effects (types and grading) of Nivolumab | Adverse effects (types and grading) of Nivolumab | 2-4 months |
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