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

Sponsor
Trisha Wise-Draper (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03355560
Collaborator
Bristol-Myers Squibb (Industry)
39
Enrollment
2
Locations
1
Arm
64.8
Anticipated Duration (Months)
19.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 6, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab

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

Drug: Nivolumab
Nivolumab 480 mg IV infusion
Other Names:
  • Opdivo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients with Grade 3 and 4 adverse events of nivolumab [28 weeks]

    Secondary Outcome Measures

    1. Percentage of patients any grade adverse events of nivolumab [28 weeks]

    2. Disease free survival [1 year]

    3. Disease free survival [2 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karmanos Cancer Institute Detroit Michigan United States 48201
    2 UC Health Cincinnati Ohio United States 45219

    Sponsors and Collaborators

    • Trisha Wise-Draper
    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Trisha Wise-Draper, MD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Trisha Wise-Draper, Principal Investigator, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT03355560
    Other Study ID Numbers:
    • UCCI-HN-17-01
    • CA209-997
    First Posted:
    Nov 28, 2017
    Last Update Posted:
    Jul 1, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Nivolumab

    Study Results

    No Results Posted as of Jul 1, 2021