Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03247712
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2017-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Immunoradiotherapy in Head & Neck Cancer
Sponsor:
Providence Health & Services
Organization:
Study Overview
Official Title:
Neoadjuvant Immunoradiotherapy: Head & Neck Cancer (NIRT-HNC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
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:
The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.
Detailed Description:
This clinical trial uses nivolumab and radiotherapy prior to definitive surgical resection of tumors in patients with Head and Neck Squamous Cell Carcinoma (OHNSCC) with the primary objective of determining the safety and feasibility of preoperative immunoradiotherapy. In addition, tumor tissue, microbiome samples, and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters. This is the first study to evaluate the safety and efficacy of neoadjuvant radiation + PD-1 blockade in patients with HNSCC.
Estimated duration of 20 weeks: neoadjuvant immunoradiotherapy +/- surgery, followed by 6 doses of nivolumab 480mg IV q4wks +/- risk-adapted adjuvant therapy, per standard of care.
Phase I safety lead-in study (n = 6) evaluating the safety of neoadjuvant immunoradiotherapy in HNSCC, followed by phase II efficacy study (n = 28, total) to assess rate of down-staging after neoadjuvant immunoradiotherapy using Simon's two-stage design (futility assessment at n = 12).
The phase 1 portion of this study will require 6 patients and is therefore expected to complete in 6 months. Although non-surgical patients are eligible to enroll, they will not be counted toward accrual for either the primary safety endpoint, (as by definition, unplanned delay of surgery cannot exist); nor the secondary efficacy endpoint, as potential for surgical staging is absent.
So long as 2 or fewer surgical delays are observed (primary safety endpoint), the phase 2 portion of study will proceed (secondary efficacy endpoint). Patients will be followed for disease free and overall survival at 5 years.
Eligible patients may be enrolled unless a rate of unplanned surgical delay attributed to immunoradiotherapy is found to exceed 33% after enrollment of the first 6 patients. We estimate 10 to 20 patients per year will be enrolled.
Estimated duration of 20 weeks: neoadjuvant immunoradiotherapy +/- surgery, followed by 6 doses of nivolumab 480mg IV q4wks +/- risk-adapted adjuvant therapy, per standard of care.
Phase I safety lead-in study (n = 6) evaluating the safety of neoadjuvant immunoradiotherapy in HNSCC, followed by phase II efficacy study (n = 28, total) to assess rate of down-staging after neoadjuvant immunoradiotherapy using Simon's two-stage design (futility assessment at n = 12).
The phase 1 portion of this study will require 6 patients and is therefore expected to complete in 6 months. Although non-surgical patients are eligible to enroll, they will not be counted toward accrual for either the primary safety endpoint, (as by definition, unplanned delay of surgery cannot exist); nor the secondary efficacy endpoint, as potential for surgical staging is absent.
So long as 2 or fewer surgical delays are observed (primary safety endpoint), the phase 2 portion of study will proceed (secondary efficacy endpoint). Patients will be followed for disease free and overall survival at 5 years.
Eligible patients may be enrolled unless a rate of unplanned surgical delay attributed to immunoradiotherapy is found to exceed 33% after enrollment of the first 6 patients. We estimate 10 to 20 patients per year will be enrolled.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: