Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sulsau-Ul Haque; Trisha Wise-Draper
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

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.