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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Trisha Wise-Draper
Study ID
NCT03355560
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab 480 mg IV infusion

Study Details

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.

Key Dates

Start date
Dec 6, 2017
Status verified
Apr 2026
Primary completion
Jan 1, 2024
Completion
Apr 15, 2026

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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. ]

Locations (2)

FacilityCityStateZIP
Karmanos Cancer InstituteDetroitMichigan48201
UC HealthCincinnatiOhio45219

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