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

Trisha Wise-Draper

Status and phase

Active, not recruiting

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03355560

CA209-997 (Other Identifier)

UCCI-HN-17-01

Details and patient eligibility

About

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.

Enrollment

39 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.