Status:
ACTIVE_NOT_RECRUITING
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Lead Sponsor:
Trisha Wise-Draper
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03355560
Start Date
December 6 2017
End Date
July 1 2024
Last Update
February 28 2024
Active Locations (2)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
UC Health
Cincinnati, Ohio, United States, 45219