Back to resultsAdjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Primary Purpose
Head and Neck Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options
- Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.
- Able to provide archived biopsy or resected tissue.
- Adequate performance status and labs.
Exclusion Criteria:
- Patients who did not receive at least radiotherapy as prior definitive treatment.
- Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.
- Has nasopharyngeal or sinonasal carcinoma.
- Has confirmed metastatic disease.
Sites / Locations
- Karmanos Cancer Institute
- UC Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nivolumab
Arm Description
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Outcomes
Primary Outcome Measures
Percentage of patients with Grade 3 and 4 adverse events of nivolumab
Secondary Outcome Measures
Percentage of patients any grade adverse events of nivolumab
Disease free survival
Disease free survival
Full Information
NCT ID
NCT03355560
First Posted
November 22, 2017
Last Updated
October 24, 2023
Sponsor
Trisha Wise-Draper
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03355560
Brief Title
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Official Title
A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
November 23, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trisha Wise-Draper
Collaborators
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Nivolumab 480 mg IV infusion
Primary Outcome Measure Information:
Title
Percentage of patients with Grade 3 and 4 adverse events of nivolumab
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients any grade adverse events of nivolumab
Time Frame
28 weeks
Title
Disease free survival
Time Frame
1 year
Title
Disease free survival
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options
Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.
Able to provide archived biopsy or resected tissue.
Adequate performance status and labs.
Exclusion Criteria:
Patients who did not receive at least radiotherapy as prior definitive treatment.
Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.
Has nasopharyngeal or sinonasal carcinoma.
Has confirmed metastatic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35653116
Citation
Leddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554.
Results Reference
derived
Learn more about this trial
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
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