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

NCT03355560

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: UCCI-HN-17-01
  • SECONDARY ID: CA209-997
  • NCT ID: NCT03355560

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivoNivolumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimentalNivolumab starting 4-11 weeks after surgery for 12 doses.
  • Nivolumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of patients with Grade 3 and 4 adverse events of nivolumab
Time Frame:28 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percentage of patients any grade adverse events of nivolumab
Time Frame:28 weeks
Safety Issue:
Description:
Measure:Disease free survival
Time Frame:1 year
Safety Issue:
Description:
Measure:Disease free survival
Time Frame:2 year
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Trisha Wise-Draper

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