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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355560
Recruitment Status : Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : October 4, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Trisha Wise-Draper, University of Cincinnati

Study Description
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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
Head and Neck Cancer Drug: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 6, 2017
Estimated Primary Completion Date : September 23, 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab starting 4-11 weeks after surgery for 6 doses.
 Drug: Nivolumab
Nivolumab 480 mg IV infusion
Other Name: Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with Grade 3 and 4 adverse events of nivolumab [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients any grade adverse events of nivolumab [ Time Frame: 28 weeks ]
  2. Disease free survival [ Time Frame: 1 year ]
  3. Disease free survival [ Time Frame: 2 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355560


Locations
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United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Ohio
UC Health
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Trisha Wise-Draper
Bristol-Myers Squibb
Investigators
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Principal Investigator: Trisha Wise-Draper, MD University of Cincinnati
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03355560    
Other Study ID Numbers: UCCI-HN-17-01
CA209-997 ( Other Identifier: Bristol Meyers Squibb )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nivolumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action