Phase 2
N=39
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03355560 ↗Enrolled (actual)
39
Serious AEs
23.1%
Results posted
May 2026
Primary outcome: Primary: Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trisha Wise-Draper
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab |
17 | — |
| SECONDARY Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab |
37 | — |
| SECONDARY Disease Free Survival |
71.37 | — |
| SECONDARY Disease Free Survival |
71.37 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03355560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.