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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab

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

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Nivolumab 480 mg IV infusion

Interventions

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Nivolumab

Nivolumab 480 mg IV infusion

Intervention Type DRUG

Other Intervention Names

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Opdivo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No