Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/4/2018 |
| Start Date: | December 6, 2017 |
| End Date: | November 2020 |
| Contact: | UC Cancer Institute Clinical Trials Office |
| Email: | cancer@uchealth.com |
| Phone: | 513-584-7698 |
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
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.
salvage resection in head and neck cancer in patients that have previously received
definitive radiation with or without chemotherapy.
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.
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