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

Phase 2

Active, not recruiting

• Conditions: Head and Neck Cancer
• Interventions: Drug: Nivolumab

• Registration Number: NCT03355560
• Lead Sponsor: Trisha Wise-Draper

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-28
• Study Start: 2017-12-06
• Primary Completion: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Grade 3 and 4 adverse events of nivolumab	28 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients any grade adverse events of nivolumab	28 weeks
Disease free survival	2 year

Trial Locations

Locations (2)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

UC Health; 🇺🇸 Cincinnati, Ohio, United States