Head and Neck Cancer
Conditions
Brief 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.
Interventions
DRUGNivolumab
Nivolumab 480 mg IV infusion
Sponsors
Trisha Wise-Draper
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab | 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. | As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab | AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months. | As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one adverse while on treatment of nivolumab for a minimum of 30 days following the last dose of study treatment. Adverse Events were not collected beyond the 30 days following the last dose. |
| Disease Free Survival | Median follow up was 22.1 months | The primary endpoint of this study was disease free survival (DFS) at 2-years as measured from the time of treatment allocation to the first evidence of any tumor or death from any cause. The "median follow-up of 22.1 months" reflects the actual duration of follow-up across participants at the time of data analysis. While the outcome measure was designed to be assessed at the 2-year mark, not all participants had reached exactly 24 months of follow-up when the data were analyzed. Therefore, the median follow-up time represents the central tendency of the follow-up duration for the cohort. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTrisha Wise-Draper, MD
University of Cincinnati
Baseline characteristics
| Characteristic | — |
|---|---|
| >10 pack year tobacco smoking history | 24 Participants |
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 39 |
| other Total, other adverse events | 37 / 39 |
| serious Total, serious adverse events | 9 / 39 |
Outcome results
None listed