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

Sponsor: Trisha Wise-Draper

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03355560

Patient View

This clinical trial evaluates the safety and efficacy of nivolumab, administered as a 480 mg IV infusion, in head and neck cancer patients post-salvage resection. Eligible participants must have undergone prior definitive radiation therapy, possess pre-operative scans, and provide tissue samples. Adequate performance status and lab results are required for inclusion.

Patient Parameters

Program Overview

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.

Eligibility 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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.