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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2020

Interventions

  • Drug: Nivolumab
    • Nivolumab 480 mg IV infusion

Arms, Groups and Cohorts

  • Experimental: Nivolumab
    • Nivolumab starting 4-11 weeks after surgery for 6 doses.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients with Grade 3 and 4 adverse events of nivolumab
    • Time Frame: 28 weeks

Secondary Measures

  • Percentage of patients any grade adverse events of nivolumab
    • Time Frame: 28 weeks
  • Disease free survival
    • Time Frame: 1 year
  • Disease free survival
    • Time Frame: 2 year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Trisha Wise-Draper
  • Collaborator
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Trisha Wise-Draper, Principal Investigator – University of Cincinnati
  • Overall Official(s)
    • Trisha Wise-Draper, MD, Principal Investigator, University of Cincinnati
  • Overall Contact(s)
    • UC Cancer Institute Clinical Trials Office, 513-584-7698, cancer@uchealth.com

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