This research study is studying a combination of two immunotherapy drugs, as a possible treatment for locoregionally recurrent squamous cell carcinoma of the head and neck. The immunotherapy drugs involved in this study are: * Nivolumab (Opdivo™) * Lirilumab
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether it works in treating a specific disease. "Investigational" means that the drug/s is being studied. The purpose of this study is to evaluate effectiveness (how well the drug/s work) of nivolumab in combination with lirilumab in participants with SCCHN. Nivolumab and lirilumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. Both nivolumab and lirilumab have been demonstrated to activate the immune system to attack cancer cells in participants with different types of cancers. In November, 2016, the Food and Drug Administration (FDA) approved nivolumab for the treatment of participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Lirilumab is not FDA approved as of now.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
1-Year Disease-Free Survival Percentage
The percentage of patients who were alive and disease free at one year past salvage surgery. Patients who were alive at last contact prior to the one year mark are censored. Data analysis conducted through Kaplan Meier methods.
Time frame: 1 year since salvage surgery, up to 1 year and 23 days since treatment start
Response at Time of Salvage Surgery
Response is classified using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Complete Response - Disappearance of all lesions and pathologic lymph nodes. Partial Response - At least 30% decrease in sum of longest diameters (SLD) for the target lesions, no new lesions, and no progression of non-target lesions. Progressive Disease - At least 20% increase in SLD compared to smallest SLD in study or progression of non-target lesions or development of new lesions Stable Disease - No Partial Response and no Progressive Disease.
Time frame: At the time of salvage surgery, up to 23 days from treatment start date.
Median Disease-Free Survival Rate
The median time that patients were alive and disease free after salvage surgery. Patients who were alive at last contact are censored at last contact. Data analysis conducted through Kaplan Meier methods
Time frame: Up to 27.2 months post salvage surgery, up to 28 months total.
1-Year Overall Survival Percentage
Percentage of participants who were alive at 1 year since salvage surgery. Patients alive at last contact prior to 1 year were censored.
Time frame: 1 year post salvage surgery, up to 1 year and 23 days post treatment start.
Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score
The median change in Programmed Cell Death Ligand - 1 Combined Positive Score (PD-L1 CPS) from baseline to surgery. The score is derived from tumor tissue samples that measures the presence of both tumor and immune cell staining for the PD-L1 marker. Scored from 0-100, a higher score suggests the patient might respond better to treatment. A pathological responder is defined as having less than 50% viable tumor at the time of surgery.
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Time frame: Measured at baseline and then at time of salvage surgery, up to 23 days.