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Phase 2 Completed N=39 Treatment

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

Source: ClinicalTrials.gov NCT03355560 ↗
Enrolled (actual)
39
Serious AEs
23.1%
Results posted
May 2026
Primary outcomePrimary: Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab — 17 Participants

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.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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