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NCT03355560 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03355560
Other study ID # UCCI-HN-17-01
Secondary ID CA209-997
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 6, 2017
Est. completion date July 2024

Study information
Verified date February 2024
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 39
Est. completion date July 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nivolumab
Nivolumab 480 mg IV infusion

Locations
Country Name City State
United States UC Health Cincinnati Ohio
United States Karmanos Cancer Institute Detroit Michigan

Sponsors (2)
Lead Sponsor Collaborator
Trisha Wise-Draper Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with Grade 3 and 4 adverse events of nivolumab 28 weeks
Secondary Percentage of patients any grade adverse events of nivolumab 28 weeks
Secondary Disease free survival 1 year
Secondary Disease free survival 2 year
See also
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