Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers

Inclusion Criteria

• Histologically proven salivary gland carcinoma (World Health Organization [WHO], 2005) arising from a previous head and neck primary site, and located within the head and neck region, lung or bone, and who are not candidates for curative intent therapy
• Demonstrated disease progression during, or after discontinuation, of the most recent line of systemic therapy. For patients who have received no prior systemic therapy, demonstrated progression in the 3 months prior to trial participation assessed by the treating physician
• Have received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting)
• Have a lesion/s deemed suitable by the treating physicians for stereotactic body radiation therapy (SBRT) with the intent of palliation or prevention of symptoms. This lesion must be:
• 1-3 non-overlapping sites in the head and neck region OR
• Metastatic lesions outside the head and neck (H&N) region in the lung or bone (a minimum of 1 and a maximum 5 lesions will be irradiated), provided there is no significant overlap between the lesions ** Patients should have RECIST 1.1 criteria measurable disease in addition to the lesion/s treated with SBRT. If the site/s of SBRT were previously radiated to high dose radiation therapy (RT) (> 50Gy), there should be > 6 month time interval between the last dose of radiation and the start of SBRT
• Have the ability to tolerate required SBRT-related procedures (e.g.: lie flat and hold position for treatment) as determined by the treating physician
• Be willing and able to provide written informed consent for the trial and comply with the study visit requirements
• Have measurable disease based on RECIST 1.1. (in addition to the lesion/s that will be treated with stereotactic radiation therapy)
• Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Tissue requirement will be waived if deemed contraindicated or not clinically available/accessible for resection per the treating physician (principal investigator [PI] approval required)
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Hemoglobin >= 9.0 g/dL (performed within 28 days of treatment initiation)
• Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L (>= 1500 per mm^3) (performed within 28 days of treatment initiation)
• Platelet count >= 100 x 10^9 /L (>= 100,000 per mm^3) (performed within 28 days of treatment initiation)
• Serum bilirubin = 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance (performed within 28 days of treatment initiation)
• Evidence of post-menopausal status OR negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• Women = 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
• Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Female subjects of childbearing potential should be willing to use 1 method of highly effective birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 180 days after the last dose of study medication. Subjects of childbearing pot