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Completed

NCT Number: NCT03355560

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

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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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karmanos Cancer Institute, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nivolumab

Drug

Nivolumab 480 mg IV infusion

Other names: Opdivo

Primary outcomes

  1. Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab

    Time frame: AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.

    As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.

Secondary outcomes

  1. Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab

    Time frame: AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.

    As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one adverse while on treatment of nivolumab for a minimum of 30 days following the last dose of study treatment. Adverse Events were not collected beyond the 30 days following the last dose.

  2. Disease Free Survival

    Time frame: Median follow up was 22.1 months

    The primary endpoint of this study was disease free survival (DFS) at 2-years as measured from the time of treatment allocation to the first evidence of any tumor or death from any cause.

    The "median follow-up of 22.1 months" reflects the actual duration of follow-up across participants at the time of data analysis. While the outcome measure was designed to be assessed at the 2-year mark, not all participants had reached exactly 24 months of follow-up when the data were analyzed. Therefore, the median follow-up time represents the central tendency of the follow-up duration for the cohort.

  3. Disease Free Survival

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Trisha Wise-Draper

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Nov 28, 2017
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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