Description:
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.
Title
- Brief Title: Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
- 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 IDs
- ORG STUDY ID:
UCCI-HN-17-01
- SECONDARY ID:
CA209-997
- NCT ID:
NCT03355560
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo | Nivolumab |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
Nivolumab | Experimental | Nivolumab starting 4-11 weeks after surgery for 6 doses. | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of patients with Grade 3 and 4 adverse events of nivolumab |
Time Frame: | 28 weeks |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Percentage of patients any grade adverse events of nivolumab |
Time Frame: | 28 weeks |
Safety Issue: | |
Description: | |
Measure: | Disease free survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Measure: | Disease free survival |
Time Frame: | 2 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Trisha Wise-Draper |
Last Updated
July 1, 2021