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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • UC Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab	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.	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.
Disease Free Survival	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.	Median follow up was 22.1 months
Disease Free Survival		2 year

Collaborators and Investigators

• Sponsor: Trisha Wise-Draper
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Trisha Wise-Draper, MD, University of Cincinnati

Publications and helpful links

General Publications

• Leddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab
• Other Study ID Numbers: UCCI-HN-17-01; CA209-997 (Other Identifier: Bristol Meyers Squibb)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No