NCT03355560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

December 6, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
21 days until next milestone

Results Posted

Study results publicly available

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

6.1 years

First QC Date

November 22, 2017

Results QC Date

September 20, 2025

Last Update Submit

April 15, 2026

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab

    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

    Median follow up was 22.1 months

  • Disease Free Survival

    2 year

Study Arms (1)

Nivolumab

EXPERIMENTAL

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

Drug: Nivolumab

Interventions

NivolumabDRUG

Nivolumab 480 mg IV infusion

Also known as: Opdivo
Nivolumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

UC Health

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

  • 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.

    PMID: 35653116DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Trisha Wise-Draper M.D., Ph.D.
Organization
University of Cincinnati Cancer Center
wiseth@ucmail.uc.edu
(513) 558-2826

Study Officials

  • Trisha Wise-Draper, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 28, 2017

Study Start

December 6, 2017

Primary Completion

January 1, 2024

Study Completion

April 15, 2026

Last Updated

May 6, 2026

Results First Posted

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)