NCT03355560
Active, not recruiting
Phase 2
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
Trisha Wise-Draper2 sites in 1 country39 target enrollmentStarted: December 6, 2017Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Trisha Wise-Draper
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Percentage of patients with Grade 3 and 4 adverse events of nivolumab
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nivolumab
Experimental
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
Percentage of patients with Grade 3 and 4 adverse events of nivolumab
Time Frame: 28 weeks
Secondary Outcomes
- Percentage of patients any grade adverse events of nivolumab(28 weeks)
- Disease free survival(2 year)
Investigators
Trisha Wise-Draper
Principal Investigator
University of Cincinnati
Study Sites (2)
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