Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603248
Status:
UNKNOWN
Last Update Posted:
2022-02-11
First Post:
2020-10-08
Brief Title:
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent andor Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent andor Metastatic Head and Neck Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study for identification of immune determinants for response to Nivolumab in Recurrent Metastatic HNSCCHead and neck squamous cell carcinoma patients
Recurrent and metastatic head and neck squamous cell carcinoma is incurable and requires aggressive treatment resulting in functional disability dismal prognosis and high mortality rate Prognosis of Recurrent and metastatic head and neck squamous cell carcinoma is poor with limited treatment options and survival rates of 6-9 months following standard-of-care SOC therapies Clinical trials have demonstrated promising clinical activity of anti PD-1programmed death-1 therapy in head and neck squamous cell carcinoma Currently nivolumab were approved for head and neck squamous cell carcinoma refractory to platinum-based therapy However the response rate of anti PD-1programmed death-1 therapy is relatively low and durable clinical benefit is limited to the minority of patients Moreover the presence of PD-1programmed death-1 did not clearly predict response and treatment survival outcome reflecting imperfection of this biomarker Actually PD-1programmed death-1 negativity cannot preclude the therapeutic benefit of PD-1programmed death-1 blockade and vice versa Hence development of reliable predictive biomarkers is essential for proper patient selection to maximize clinical benefit of PD-1programmed death-1 blockade in head and neck squamous cell carcinoma patients
Therefore we need to select patients who are most likely to benefit from anti PD-1programmed death-1 therapy and identify the better biomarker to predict the response to PD-1programmed death-1 blockade in head and neck squamous cell carcinoma patients patients earlier than tumor assessment by imaging scan
In the current study we aimed to elucidate immune-related biomarkers to predict response with tumor tissue and peripheral blood from Recurrent Metastatic HNSCCHead and neck squamous cell carcinoma patients treated with nivolumab
Recurrent and metastatic head and neck squamous cell carcinoma is incurable and requires aggressive treatment resulting in functional disability dismal prognosis and high mortality rate Prognosis of Recurrent and metastatic head and neck squamous cell carcinoma is poor with limited treatment options and survival rates of 6-9 months following standard-of-care SOC therapies Clinical trials have demonstrated promising clinical activity of anti PD-1programmed death-1 therapy in head and neck squamous cell carcinoma Currently nivolumab were approved for head and neck squamous cell carcinoma refractory to platinum-based therapy However the response rate of anti PD-1programmed death-1 therapy is relatively low and durable clinical benefit is limited to the minority of patients Moreover the presence of PD-1programmed death-1 did not clearly predict response and treatment survival outcome reflecting imperfection of this biomarker Actually PD-1programmed death-1 negativity cannot preclude the therapeutic benefit of PD-1programmed death-1 blockade and vice versa Hence development of reliable predictive biomarkers is essential for proper patient selection to maximize clinical benefit of PD-1programmed death-1 blockade in head and neck squamous cell carcinoma patients
Therefore we need to select patients who are most likely to benefit from anti PD-1programmed death-1 therapy and identify the better biomarker to predict the response to PD-1programmed death-1 blockade in head and neck squamous cell carcinoma patients patients earlier than tumor assessment by imaging scan
In the current study we aimed to elucidate immune-related biomarkers to predict response with tumor tissue and peripheral blood from Recurrent Metastatic HNSCCHead and neck squamous cell carcinoma patients treated with nivolumab
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None